Feasibility of pure EFTR using an innovative new endoscopic suturing device: the Double-arm-bar Suturing System (with video)

Background

Endoscopic full-thickness resection (EFTR) requires a reliable full-thickness suturing device and an endoscopic counter-traction device to prevent the collapse of the digestive tract.

Objective

The present study aimed to assess the reliability of newly developed flexible endoscopy suturing devices and the feasibility of pure EFTR.

Methods

A total of 30 EFTRs were performed and allocated to three groups (N = 10 for each group). The full-thickness sutures were placed using over-the-scope clips (OTSCs), hand-sewn sutures, or the Double-arm-bar Suturing System (DBSS). Air leak tests were conducted in the three groups. The times required for the placement of one OTSC suture and single-stitch simple interrupted sutures (hand-sewn and DBSS sutures, respectively) were also compared.

Results

All 30 full-thickness sutures were completely and successfully placed. Regarding the air leak tests, the Mann–Whitney U test showed significant differences between OTSC and hand-sewn sutures (p = 0.003). There was also a significant difference between OTSC and DBSS sutures (p = 0.023). There was no significant difference between hand-sewn and DBSS sutures (p = 0.542). A significant difference was found in the suture time for single-stitch simple interrupted sutures among the OTSC, hand-sewn, and DBSS sutures. The Mann–Whitney U test revealed a significant difference between OTSC and hand-sewn sutures (p = 0.0001). There was no significant difference between OTSC and DBSS sutures (p = 0.533), while a significant difference was found between hand-sewn and DBSS sutures (p = 0.0001).

Conclusions

Pure EFTR is feasible if the mechanical counter traction system is used to expand a small operative field and DBSS is used to make full-thickness sutures. The high safety of full-thickness resection and full-thickness suturing allows for clinical applications of this method.     

Performance of the OTSC System in the endoscopic closure of iatrogenic gastrointestinal perforations: a systematic review

Background

Reliable closure is a prerequisite for conventional and innovative endoscopic procedures, such as NOTES. The purpose of this study is the systematic evaluation of the procedural and clinical success rates in closure of iatrogenic gastrointestinal perforations and acute anastomotic leaks by means of the over-the-scope-clip system (OTSC^®).

Design

PubMed and other sources were searched systematically for clinical and preclinical research on the evaluation of the OTSC System for closure of gastrointestinal perforations and leaks. Appraisal of studies for inclusion and data extraction was performed independently by two reviewers using an a priori determined data extraction grid. Major endpoints to be extracted were data on procedural success (successful clip application) and clinical access (durable closure of defect without secondary adjunct therapy).

Results

A total of 17 clinical research articles/abstracts and 22 preclinical research articles/abstracts were identified. The examined clinical studies comprised case series and clinical single-arm studies. The reviewed studies revealed a consistently high mean rate of procedural success of 80–100 % and durable clinical success of 57–100 %. An identified major drawback preventing successful clip application was occurrence of fibrotic or inflamed lesion edges. Usage of the OTSC System was accompanied by neither major clip-related nor application-related complication. In experimental settings, closure of larger perforations and gastric access sites of NOTES or endoscopic full-thickness resection were achieved with high rates of success.

Conclusions

Because randomized, clinical trials are not available in this field of indication, the evaluation is based on small case series. Nevertheless, by pooling all experience gained, we conclude that endoscopic closure of iatrogenic gastrointestinal perforations and acute anastomotic leaks by means of the OTSC System is a safe and effective method.     

Pure natural orifice transluminal endoscopic surgery (NOTES) with ultrasonography-guided transgastric access and over-the-scope-clip closure: a porcine feasibility and survival study

Background

Most natural orifice transluminal endoscopic surgery (NOTES) procedures to date rely on the hybrid technique with simultaneous laparoscopic access to protect against access-related complications and to achieve adequate triangulation for dissection. This is done at the cost of the potential benefits of this new minimally invasive technique. This study aimed to evaluate the feasibility and safety of a transgastric (TG) pure-NOTES procedure in a diagnostic setting.

Methods

A TG pure-NOTES procedure with endoscopic ultrasonograpy (EUS)-guided access and over-the-scope-clip (OTSC) closure was performed for 10 pigs in a survival and feasibility study. A full macroscopic necropsy with subsequent histologic evaluation was performed on postoperative day (POD) 14. The outcome parameters were uncomplicated follow-up assessment, survival, intraoperative complications, intraabdominal pathology, macroscopic full-thickness closure, and histology-proven full-thickness healing of the gastrotomy.

Results

An uncomplicated postoperative course was reported for 9 of the 10 pigs, and survival was reported for all 10 pigs. For all the pigs, EUS-guided access was performed successfully with a median duration of 25?min (range, 12–62?min) and without intraoperative complications or access-related lesions at necropsy. An OTSC closure was achieved with a median duration of 11?min (range, 3–28?min). The OTSC provided immediate closure, but according to the authors’ definition of a full-thickness healing evaluated by histologic examination, this was not achieved in any of the cases. Although all the animals survived until POD 14, intraabdominal chronic abscesses were present in 3 of the 10 pigs at necropsy.

Conclusions

The EUS-guided TG access proved to be feasible without access-related complications. Although OTSC provided an immediate closure, the histopathology raised concerns regarding the risk of perforation. Together with the high risk of intraabdominal infection, TG pure-NOTES is not yet ready for routine clinical practice.     

Stress response and well-being after open,laparoscopic, and NOTES transgastric uterine horn resection in a randomized porcine model

Background

NOTES is believed to induce less surgical trauma than open and laparoscopic surgery. The degree of surgical trauma can be assessed by measuring serum levels of acute-phase proteins such as CRP and TNF-α. We conducted a prospective randomized survival trial in which the inflammatory responses after laparoscopic, open, and NOTES transgastric uterine horn resection were compared. The aim of this study was to investigate whether NOTES procedures induce less inflammatory response.

Methods

Thirty pigs were randomized into three groups to undergo open, laparoscopic, or transgastric uterine horn resection. Weight, body temperature, and postoperative recovery were recorded and venous blood samples were taken for analysis of CRP and TNF-α at different time points. Analyses of CRP and TNF-α were performed using pig-specific ELISA assays.

Results

Procedure time was significantly longer for NOTES [median = 121 min (range = 94–155)] compared with that for open surgery [median = 22 min (14–27)] and laparoscopy [median = 37 min (20–45)] (p < 0.0001). There was a nonsignificant tendency for shorter recovery time for the NOTES animals. Twenty-seven animals survived for 4 weeks. One animal in each group was euthanized prior to 4 weeks. All animals gained weight during the 4-week period with no significant differences. Only animals in the NOTES group showed a significant weight gain during the first postoperative week (p = 0.007). On postoperative day (POD) 1, CRP was significantly lower in the NOTES group compared with the open and laparoscopic groups (mean = 0.72 ± 0.22, 0.98 ± 0.26, and 0.97 ± 0.20, respectively; p = 0.048). The CRP levels were normalized on day 14. Throughout the study there were no significant changes in TNF-α levels in the laparoscopic and NOTES groups. At POD 3 the open surgery group showed significantly higher TNF-α levels than the other groups (p = 0.036).

Conclusions

Despite the longer operating time, the transgastric NOTES approach seems to be less traumatic than open or laparoscopic uterine horn resection in this porcine model.     

Peritoneal inflammatory response of natural orifice translumenal endoscopic surgery (NOTES) versus laparoscopy with carbon dioxide and air pneumoperitoneum

Background

The immunologic and physiologic effects of natural orifice translumenal endoscopic surgery (NOTES) versus traditional surgical approaches are poorly understood. Previous investigations have shown that NOTES and laparoscopy share similar inflammatory cytokine profiles except for a possible late-phase tissue necrosis factor-α (TNF-α) depression with NOTES. The local peritoneal reaction and immunomodulatory influence of pneumoperitoneum agents in NOTES also are not known and may play an important role in altering the physiologic insult induced by NOTES.

Methods

In this study, 51 animals were divided into four study groups, which respectively underwent abdominal exploration via transgastric NOTES using room air (AIR) or carbon dioxide (CO₂) or via laparoscopy (LX) using AIR or CO₂ for pneumoperitoneum. Laparotomy and sham surgeries were additionally performed as control conditions. Measurements of TNF-α, interleukin-1β (IL-1β), and IL-6 were performed for peritoneal fluid collected after 0, 2, 4, and 6 h and on postoperative days (PODs) 1, 2, and 7.

Results

Of the 45 animals assessed, 6 were excluded because of technical operative complications. The findings showed that LX-CO₂ generated the most pronounced response with all three inflammatory markers. However, no significant differences were detected between LX-CO₂ and either NOTES group at these peak points. No differences were encountered between NOTES-CO₂ and NOTES-AIR. Subgroup comparisons showed significantly higher levels of TNF-α and IL-6 with NOTES-CO₂ than with LX-AIR on POD 1 (p = 0.022) and POD 2 (p = 0.002). The LX-CO₂ subgroup had significantly higher levels of TNF-α than the LX-AIR subgroup at 4 h (p = 0.013) and on POD 1 (p = 0.021). No late-phase TNF-α depression occurred in the NOTES animals.

Conclusion

The local inflammatory reaction to NOTES was similar to that with traditional laparoscopy, and the previously described late-phase systemic TNF-α depression in serum was not reproduced. At the peritoneal level, NOTES is no more physiologically stressful than laparoscopy. Furthermore, regardless of which gas was used, the role of the pneumoperitoneum agent did not affect the cytokine profile after NOTES, suggesting that air pneumoperitoneum is adequate for NOTES.     

Needs analysis for developing a virtual-reality NOTES simulator

Introduction and study aim

Natural orifice translumenal endoscopic surgery (NOTES) is an emerging surgical technique that requires a cautious adoption approach to ensure patient safety. High-fidelity virtual-reality-based simulators allow development of new surgical procedures and tools and train medical personnel without risk to human patients. As part of a project funded by the National Institutes of Health, we are developing the virtual transluminal endoscopic surgery trainer (VTEST?) for this purpose. The objective of this study is to conduct a structured needs analysis to identify the design parameters for such a virtual-reality-based simulator for NOTES.

Methods

A 30-point questionnaire was distributed at the 2011 National Orifice Surgery Consortium for Assessment and Research meeting to obtain responses from experts. Ordinal logistic regression and the Wilcoxon rank-sum test were used for analysis.

Results

A total of 22 NOTES experts participated in the study. Cholecystectomy (CE, 68 %) followed by appendectomy (AE, 63 %) (CE vs AE, p = 0.0521) was selected as the first choice for simulation. Flexible (FL, 47 %) and hybrid (HY, 47 %) approaches were equally favorable compared with rigid (RI, 6 %) with p < 0.001 for both FL versus RI and HY versus RI. The transvaginal approach was preferred 3 to 1 to the transgastric. Most participants preferred two-channel (2C) scopes (65 %) compared with single (1C) or three (3C) or more channels with p < 0.001 for both 2C versus 1C and 2C versus 3C. The importance of force feedback and the utility of a virtual NOTES simulator in training and testing new tools for NOTES were rated very high by the participants.

Conclusion

Our study reinforces the importance of developing a virtual NOTES simulator and clearly presents expert preferences. The results of this analysis will direct our initial development of the VTEST? platform.     

Perioperative inflammatory response in natural orifice translumenal endoscopic surgery

Background

Natural orifice translumenal endoscopic surgery (NOTES) could offer multiple advantages compared with the laparoscopic approach. One such potential advantage, not yet proven, is the inferior inflammatory response, which translates into less significant operative stress. This study aimed to compare the immuno-inflammatory response between transgastric NOTES and laparoscopy for simple surgical procedures (oophorectomy) with reference to the cytokine levels.

Methods

For this study, 20 female pigs were randomly assigned to either NOTES or laparoscopic oophorectomy. Seven animals were used as a control group and received only general anesthesia, with no other procedure performed. Blood samples were obtained before surgery, 1 h after the start of the procedure, and at the end of the intervention. The serum levels of IL1β and IL6 were determined using a porcine enzyme-linked immunosorbent assay (ELISA) kit. The mean operative time, intraoperative incidents, and postoperative complications were recorded. On postoperative day 14, the animals were killed, and gastric leak tests were performed.

Results

Both the NOTES and laparoscopic procedures were successfully completed. No gastric leaks were observed during necropsy. The transgastric oophorectomy required a significantly longer time to perform than the laparoscopic surgery. Compared with the NOTES procedures, laparoscopic oophorectomy resulted in significantly higher levels of interleukin-1β (IL1β) (42.34 ± 5.26 ng/ml with NOTES vs 46.93 ± 4.79 ng/ml with laparoscopy; p = 0.028) and IL6 (66.95 ± 7.29 ng/ml with NOTES vs 71.75 ± 4.76 ng/ml with laparoscopy, p = 0.049) during the postoperative phase. No statistical difference was detected between the pre- and postoperative cytokine levels in the NOTES group.

Conclusion

The study findings suggest that pure transgastric endoscopic surgery is a safe approach resulting in less perioperative inflammatory response than laparoscopy in the early postoperative phase.     

Survival study of natural orifice translumenal endoscopic surgery for rectosigmoid resection using transanal endoscopic microsurgery with or without transgastric endoscopic assistance in a swine model

Background

The feasibility of transanal rectosigmoid resection with transanal endoscopic microsurgery (TEM) was previously demonstrated in a swine nonsurvival model in which transgastric endoscopic assistance also was shown to extend the length of colon mobilized transanally.

Methods

A 2-week survival study evaluating transanal endoscopic rectosigmoid resection with stapled colorectal anastomosis was conducted with swine using the transanal approach alone (TEM group, n = 10) or a transanal approach combined with transgastric endoscopic assistance (TEM + TG group, n = 10). Gastrotomies were created using a needleknife and balloon dilation, then closed using prototype T-tags. Outcomes were evaluated and compared between the groups using Student’s t-test and Fisher’s exact test.

Results

Relative to the TEM group, the average length of rectosigmoid mobilized in the TEM + TG group was 15.6 versus 10.5 cm (p < 0.0005), the length of the resected specimen was 9 versus 6.2 cm (p < 0.0005), and the mean operative time was 254.5 versus 97.5 min (p < 0.0005). Intraoperatively, no organ injury or major bleeding was noted. Two T-tag misfires occurred during gastrotomy closure and four small staple line defects requiring transanal repair including one in the TEM group and three in the TEM + TG group (p = 0.2). Postoperatively, there was no mortality, and the animals gained an average of 3.4 lb. Two major complications (10%) were identified at necropsy in the TEM + TG group including an intraabdominal abscess and an abdominal wall hematoma related to T-tag misfire. Gastrotomy closure sites and colorectal anastomoses were all grossly healed, with adhesions noted in 60 and 70% and microabscesses in 50 and 20% of the gastrotomy sites and colorectal anastomoses, respectively.

Conclusions

Natural orifice translumenal endoscopic surgery (NOTES) for rectosigmoid resection using TEM with or without transgastric endoscopic assistance is feasible and associated with low morbidity in a porcine survival model. Transgastric assistance significantly prolongs the operative time but extends the length of the rectosigmoid mobilized transanally, with a nonsignificant increase in complication rates related to gastrotomy creation.     

Transvaginal natural orifice transluminal endoscopic surgery in the morbidly obese

Background

The objective of this study is to assess the safety and efficacy of transvaginal (TV) natural orifice transluminal endoscopic surgery (NOTES) operations in morbidly obese patients.

Methods

One hundred seven NOTES operations have been performed at our institution to date, of which 17 were completed in patients with body mass index (BMI) between 35 and 45 kg/m². These included 14 cholecystectomies, one appendectomy, and two ventral hernia repairs. The patients had average age of 36.2 years (range 19–62 years) and average BMI of 38.9 kg/m² (range 35.2–44.9 kg/m²). The mean number of previous abdominal operations was 1. The TV cholecystectomies were hybrid NOTES procedures, while TV appendectomy and ventral hernia repair were pure NOTES. All operations were completed with standard straight laparoscopic instruments.

Results

The mean operative time was 60 min for cholecystectomy, 41 min for TV appendectomy, and 90 min for ventral hernia repair. No significant difference was encountered between the operative time for NOTES cholecystectomies in obese versus nonobese (60 vs. 61 min, p = 0.86). No conversions to traditional laparoscopy or open surgery were made, and no major complications were encountered.

Conclusions

NOTES is an attractive alternative to laparoscopy in female patients with morbid obesity. The procedures are safe and have short operative times, good postoperative outcomes, and improved cosmesis compared with laparoscopy.     

Over-the-Scope Clip Application Yields a High Rate of Closure in Gastrointestinal Perforations and May Reduce Emergency Surgery

Background

Perforation of the gastrointestinal tract may cause various complications and may require emergency surgery, even in patients with significant comorbidities.

Methods

Seventeen consecutive patients with indication for surgery due to a visible gastrointestinal perforation were treated with OTSC application. In this study, cause of perforation, estimated size, location, rate of perforation closure, outcome and complications were reported.

Results

In 11 of 17 patients (64.7?%), OTSC application resulted in permanent closure of perforations, thus avoiding surgery. All 11 successful cases had smaller perforation lengths (5.5?±?1.9?mm, p?<?0.02), widths (3.7?±?0.9?mm) or area (21.1?±?9.1?mm²), had vital margins of perforations and 1.1?±?0.3 OTSC per patient were necessary. The six unsuccessful cases (35.3?%) showed larger perforation lengths (13.4?±?8.8?mm, p?<?0.02), widths (5?±?4.5?mm) and area (97.6?±?149?mm²), had necrotic or soft inflammatory margins and significantly more OTSC (2.3?±?0.5, p?=?0.018) were tried.

Conclusions

OTSC application yields a high rate of endoscopic perforation closure in patients with macroscopic gastrointestinal perforation, even in an emergency setting, representing an alternative to surgery, especially when the size of the lesion is not too large and when vital or solid perforation margins are expected.     

The use of the LigaSure device and the Stapler in closure of the small bowel: a comparative ex vivo study

Purpose

To evaluate the feasibility and effectiveness of the LigaSure device in closing divisions of the small bowel in an ex vivo porcine model.

Methods

Two types of closure were performed: stumps created by “muco-mucosa” fusion and stumps created by “sero-serosa” fusion. For each type of closure, different power levels of the LigaSure system were tested in combination with different numbers of applications and then compared with the Stapler group.

Results

With both types of intestinal closure, the highest value of burst pressure was obtained with the application of a power level of three bars and one frequency application. The high burst pressure of the muco-mucosa stump group was significantly lower than that of the Stapler group (41.8 ± 5.9 vs. 75.8 ± 5.9, respectively, p < 0.01). No differences were found between the high burst pressure of the sero-serosa stump group and the Stapler group (74.1 ± 5.5 vs. 75.8 ± 5.9, respectively, p = 0.2).

Conclusions

Our preliminary results showed that the LigaSure is an efficient tool for closing the intestines when sero-serosa stumps are created. The second step of our work will be to evaluate the feasibility of this tool in creating intestinal anastomoses.     

Prospective Randomized Trial of Hybrid NOTES Colectomy Versus Conventional Laparoscopic Colectomy for Left-sided Colonic Tumors

Background

We conducted a randomized study of a laparoscopic technique for removing left-sided colon tumors that can reduce postoperative pain and other wound-related complications compared to the conventional technique. It is a novel technique of hybrid natural orifice translumenal endoscopic surgery (NOTES) colectomy (HNC) whereby laparoscopic colonic mobilization, transection, and anastomosis are performed intracorporeally. The specimen is then delivered through the anus using the transanal endoscopic operation (TEO) device, precluding the need for mini-laparotomy. We compared the short-term outcomes of patients who underwent HNC with those who underwent conventional laparoscopic colectomy (CL).

Methods

Patients suffering left-sided colonic tumor were recruited and were randomized into two groups: HNC and CL. Operative data and complications were prospectively recorded and analyzed.

Results

During a 3-year period, we recruited 70 patients (35 per group). No significant difference was observed between the two groups with respect to operating time (105 vs. 100 min, p = 0.851), blood loss (30 vs. 30 ml, p = 0.954), or length of hospital stay (5 vs. 5 days, p = 0.990). The maximum pain score during the first week was significantly lower in the HNC group (1 vs. 2, p = 0.017). No patients in the HNC group developed wound infection, whereas four patients in the CL group did so (p = 0.005).

Conclusions

With this hybrid NOTES technique, selected patients with left-sided colonic tumors can enjoy the full benefits of minimally invasive surgery with significantly less wound pain and a lower wound infection rate than are observed with CL.     

Surgical site infection in spinal surgery: a comparative study between 2-octyl-cyanoacrylate and staples for wound closure

Background

Surgical site infection (SSI) after spinal surgery is a devastating complication. Various methods of skin closure are used in spinal surgery, but the optimal skin-closure method remains unclear. A recent report recommended against the use of metal staples for skin closure in orthopedic surgery. 2-Octyl-cyanoacrylate (Dermabond; Ethicon, NJ, USA) has been widely applied for wound closure in various surgeries. In this cohort study, we assessed the rate of SSI in spinal surgery using metal staples and 2-octyl-cyanoacrylate for wound closure.

Methods

This study enrolled 609 consecutive patients undergoing spinal surgery in our hospital. From April 2007 to March 2010 surgical wounds were closed with metal staples (group 1, n = 294). From April 2010 to February 2012 skin closure was performed using 2-octyl-cyanoacrylate (group 2, n = 315). We assessed the rate of SSI using these two different methods of wound closure. Prospective study of the time and cost evaluation of wound closure was performed between two groups.

Results

Patients in the 2-octyl-cyanoacrylate group had more risk factors for SSI than those in the metal-staple group. Nonetheless, eight patients in the metal-staple group compared with none in the 2-octyl-cyanoacrylate group acquired SSIs (p < 0.01). The closure of the wound in length of 10 cm with 2-octyl-cyanoacrylate could save 28 s and $13.5.

Conclusions

This study reveals that in spinal surgery, wound closure using 2-octyl-cyanoacrylate was associated with a lower rate of SSI than wound closure with staples. Moreover, the use of 2-octyl-cyanoacrylate has a more time saving effect and cost-effectiveness than the use of staples in wound closure of 10 cm in length.     

Transrectal robotic natural orifice translumenal endoscopic surgery (NOTES) applied to intestinal anastomosis in a porcine intestine model

Background

Natural orifice translumenal endoscopic surgery (NOTES) is a minimally invasive operation using devices such as flexible endoscopes and linear or circular staplers. Nevertheless, hand-sewn anastomosis in NOTES remains challenging. This study aimed to investigate the feasibility of transrectal robotic NOTES requiring intracorporeal small intestinal anastomosis and closure of the rectal anterior wall incision in a relevant human model.

Methods

The authors developed a flexible rectal proctoscope with a diameter of 43 mm for transrectal robotic NOTES. Small intestinal anastomosis was performed in a porcine intestinal transrectal NOTES model using two robotic arms and a camera inserted through the proctoscope and a rectal anterior wall incision. The quality of transrectal small intestinal anastomosis using the da Vinci surgical system (transrectal robotic NOTES group) was compared with that of transabdominal anastomosis using the da Vinci surgical system (transabdominal robot-assisted surgery group) and transrectal anastomosis using traditional transanal endoscopic microsurgery (TEM) instruments (TEM NOTES group). The quality of transrectal rectal anterior wall suturing in the transrectal robotic NOTES group was compared with that of the TEM NOTES group and the open surgical instruments group (open group).

Results

Robotic intracorporeal suturing was performed successfully in the porcine intestine model. During small intestinal anastomosis, burst pressure in the transrectal robotic NOTES group (67.7 ± 29.3 mmHg) was similar to that in the transabdominal robot-assisted surgery group (73.3 ± 18.2 mmHg) but significantly higher than in the TEM NOTES group (20.3 ± 24.0 mmHg; p < 0.01). During rectal anterior wall suturing, the burst pressure did not differ significantly between the transrectal robotic NOTES group (149.9 ± 81.1 mmHg) and the open group (195.0 ± 60.5 mmHg).

Conclusions

The preliminary safety and efficacy of transrectal robotic NOTES was established. Further studies are required to determine the practical feasibility of this procedure.     

A comparison of NOTES transvaginal and laparoscopic cholecystectomy procedures based upon task analysis

Background

A virtual reality-based simulator for natural orifice translumenal endoscopic surgery (NOTES) procedures may be used for training and discovery of new tools and procedures. Our previous study (Sankaranarayanan et al. in Surg Endosc 27:1607–1616, 2013) shows that developing such a simulator for the transvaginal cholecystectomy procedure using a rigid endoscope will have the most impact on the field. However, prior to developing such a simulator, a thorough task analysis is necessary to determine the most important phases, tasks, and subtasks of this procedure.

Methods

19 rigid endoscope transvaginal hybrid NOTES cholecystectomy procedures and 11 traditional laparoscopic procedures have been recorded and de-identified prior to analysis. Hierarchical task analysis was conducted for the rigid endoscope transvaginal NOTES cholecystectomy. A time series analysis was conducted to evaluate the performance of the transvaginal NOTES and laparoscopic cholecystectomy procedures. Finally, a comparison of electrosurgery-based errors was performed by two independent qualified personnel.

Results

The most time-consuming tasks for both laparoscopic and NOTES cholecystectomy are removing areolar and connective tissue surrounding the gallbladder, exposing Calot’s triangle, and dissecting the gallbladder off the liver bed with electrosurgery. There is a positive correlation of performance time between the removal of areolar and connective tissue and electrosurgery dissection tasks in NOTES (r = 0.415) and laparoscopic cholecystectomy (r = 0.684) with p < 0.10. During the electrosurgery task, the NOTES procedures had fewer errors related to lack of progress in gallbladder removal. Contrarily, laparoscopic procedures had fewer errors due to the instrument being out of the camera view.

Conclusion

A thorough task analysis and video-based quantification of NOTES cholecystectomy has identified the most time-consuming tasks. A comparison of the surgical errors during electrosurgery gallbladder dissection establishes that the NOTES procedure, while still new, is not inferior to the established laparoscopic procedure.     

Transanal rectosigmoid resection via natural orifice translumenal endoscopic surgery (NOTES) with total mesorectal excision in a large human cadaver series

Background

The authors’ group has previously described successful transanal rectosigmoid resection via natural orifice translumenal endoscopic surgery (NOTES) in both porcine and cadaveric models using the transanal endoscopic microsurgery platform. This report describes the largest cadaveric series to date as optimization of this approach for clinical application continues.

Methods

Between December 2008 and September 2011, NOTES transanal rectosigmoid resection with total mesorectal excision (TME) was successfully performed in 32 fresh human cadavers using transanal dissection alone (n = 19), with transgastric endoscopic assistance (n = 5), or with laparoscopic assistance (n = 8). The variables recorded were gender, body mass index (BMI), operative time, length of the mobilized specimen, integrity of the mesorectum and the resected specimen, and complications. Univariate statistical analysis was performed.

Results

Of the 32 cadavers, 22 were male with a mean BMI of 24 kg/m² (range 16.3–37 kg/m²). The mean operative time was 5.1 h (range 3–8 h), and the mean specimen length was 53 cm (range 15–91.5 cm). After the first five cadavers, specimen length significantly improved, and a trend toward decreased operative time was demonstrated. The mesorectum was intact in 100 % of the specimens. In nine cadavers, endoscopic dissection was complicated by organ injury. Evaluation by the operative approach demonstrated a significantly longer specimen with laparoscopic assistance (67.7 cm) than with transgastric assistance (45.4 cm) or transanal dissection alone (49.2 cm) (p = 0.013). Comparison of the technique used for inferior mesenteric pedicle division demonstrated both significantly decreased operative time (4.8 vs 6 h; p = 0.024) and increased specimen length (57.7 vs 39.6 cm; p = 0.025) when a stapler was used in lieu of a bipolar cautery device.

Conclusion

Transanal NOTES rectosigmoid resection with TME is feasible and demonstrates improvement in specimen length and operative time with experience. Transitioning to clinical application requires laparoscopic assistance to overcome limitations related to NOTES instrumentation, as well as procedural training with fresh human cadavers.     

Timing of premature physeal closure in Legg-Calve-Perthes Disease

Purpose

Premature physeal closure of the proximal femoral physis has been reported in Legg-Calve-Perthes Disease (LCPD). However, the timing of its occurrence had not yet been reported. We proposed (1) to determine the timing of premature physeal closure in unilateral LCPD with serial radiographic evaluation, and (2) to evaluate the relationship between the premature physeal closure and Herring classification, leg-length discrepancy (LLD), Stulberg classification, and trochanteric overgrowth.

Methods

We performed a retrospective study with serial radiographs of 27 patients diagnosed with LCPD. The difference in the timing of physeal closure between the hips was calculated. The involved hip was classified according to Herring classification. The LLD and ATD index at latest follow up was measured. The mean values were calculated and statistical comparison of variables was done using the Fisher’s exact test.

Results

The mean difference of physeal closure at the involved hip compared to the uninvolved side was 3.5 years (range, two to five years). Hips demonstrating premature physeal closure were associated with Herring B/C and C (p?=?0.01) and LLD >1 cm (p?=?0.02). There is no correlation between Stulberg classification, trochanteric overgrowth and premature physeal closure (p?=?0.06 and p?=?0.19).

Conclusions

We may expect premature physeal closure of the proximal femoral physis in patients with LCPD to occur 3.5 years earlier than normal hips. Presence of premature physeal closure can be an adjunct diagnostic tool in the prognostication of LCPD outcomes. Future studies directed toward premature physeal closure in LCPD and associated growth disturbances are necessary.     

Prospective Study Examining Clinical Outcomes Associated with a Negative Pressure Wound Therapy System and Barker’s Vacuum Packing Technique

Background

The open abdomen has become a common procedure in the management of complex abdominal problems and has improved patient survival. The method of temporary abdominal closure (TAC) may play a role in patient outcome.

Methods

A prospective, observational, open-label study was performed to evaluate two TAC techniques in surgical and trauma patients requiring open abdomen management: Barker’s vacuum-packing technique (BVPT) and the ABThera^TM open abdomen negative pressure therapy system (NPWT). Study endpoints were days to and rate of 30-day primary fascial closure (PFC) and 30-day all-cause mortality.

Results

Altogether, 280 patients were enrolled from 20 study sites. Among them, 168 patients underwent at least 48 hours of consistent TAC therapy (111 NPWT, 57 BVPT). The two study groups were well matched demographically. Median days to PFC were 9 days for NPWT versus 12 days for BVPT (p = 0.12). The 30-day PFC rate was 69 % for NPWT and 51 % for BVPT (p = 0.03). The 30-day all-cause mortality was 14 % for NPWT and 30 % for BVPT (p = 0.01). Multivariate logistic regression analysis identified that patients treated with NPWT were significantly more likely to survive than the BVPT patients [odds ratio 3.17 (95 % confidence interval 1.22–8.26); p = 0.02] after controlling for age, severity of illness, and cumulative fluid administration.

Conclusions

Active NPWT is associated with significantly higher 30-day PFC rates and lower 30-day all-cause mortality among patients who require an open abdomen for at least 48 h during treatment for critical illness.     

Long-Term Outcomes Comparing Surgery to Embolization-Ablation for Treatment of Solitary HCC <7 cm

Background

Resection has been the standard of care for patients with solitary hepatocellular carcinoma (HCC). Transarterial embolization and percutaneous ablation are alternative therapies often reserved for suboptimal surgical candidates. Here we compare long-term outcomes of patients with solitary HCC treated with resection versus combined embo-ablation.

Methods

We previously reported a retrospective comparison of resection and embo-ablation in 73 patients with solitary HCC <7 cm after a median follow-up of 23 months. This study represents long-term updated follow-up over a median of 134 months.

Results

There was no difference in survival among Okuda I patients who underwent resection versus embo-ablation (66 vs 58 months, p = .39). There was no difference between the groups in the rate of distant intrahepatic (p = .35) or metastatic progression (p = .48). Surgical patients experienced more complications (p = .004), longer hospitalizations (p < .001), and were more likely to require hospital readmission within 30 days of discharge (p = .03).

Conclusion

Over a median follow up of more than 10 years, we found no significant difference in overall survival of Okuda 1 patients with solitary HCC <7 cm who underwent surgical resection versus embo-ablation. Our data suggest that there may be a greater role for primary embo-ablation in the treatment of potentially resectable solitary HCC.     

Comparison of immediate postoperative pain after transvaginal versus traditional laparoscopic cholecystectomy

Background

Transvaginal cholecystectomy (TVC) is the most common natural orifice transluminal surgery (NOTES) performed in women, yet there is a paucity of data on intraoperative and immediate postoperative pain management. Previous studies have demonstrated that NOTES procedures are associated with less postoperative pain and faster recovery times. This study analyzes intraoperative and postoperative opioid use for TVC compared with traditional four-port laparoscopic cholecystectomies (LCs).

Methods

This is a retrospective analysis of consecutive TVC and LC female patients between August 2009 and August 2012 in an academic institution. We compared demographics, intraoperative and postoperative opioid use and times in the operating room (OR) and in the post anesthesia care unit (PACU).

Results

A total of 68 TVC and 67 LC patients were included in this study. The TVC and LC groups were similar in terms of age (both 41 years) and body mass index (29 and 31 kg/m², respectively). The intraoperative preparation, surgical, and emergence times were significantly longer for the TVC than for the LC (p ≤ 0.01). Compared with the LC group, the intraoperative opioid requirement was significantly greater (TVC 27 mg vs. LC 25 mg; p = 0.003), but after adjusting for anesthesia time, the difference in OR opioid consumption became non-significant (p = 0.08). The PACU opioid requirement (TVC 2.5 vs. LC 5 mg; p = 0.04) was significantly lower for the TVC group, and a greater proportion of patients did not need any pain medications (TVC 38 % vs. LC 21 %; p = 0.04), compared with the LC group. The average PACU pain scores were not significantly different between the groups (p = 0.45).

Conclusion

TVC patients did not experience more pain than LC patients. Although the average pain scores of TVC patients did not differ from those of the LC patients, TVC patients did require less pain medication in the PACU.