Pure natural orifice transluminal endoscopic surgery (NOTES) cholecystectomy

Enthusiasm for natural orifice transluminal endoscopic surgery (NOTES) has been partly tempered by the reality that most NOTES procedures to date have been laparoscopically assisted. After safely performing transvaginal cholecystectomy in an IACUC-approved porcine model, the authors embarked on an institution review board (IRB)-approved protocol for ultimate performance of pure NOTES cholecystectomy in humans. They describe their experience performing a true NOTES transvaginal cholecystectomy after safely accomplishing three laparoscopically assisted or hybrid procedures in humans. One of the patients was a 35-year-old woman presenting with symptoms of biliary colic. Ultrasound confirmed gallstones, and her liver enzymes were normal. Pneumoperitoneum to 15 mmHg was obtained via a transvaginal trocar placed through a colpotomy made under direct vision. A double-channel endoscope then was advanced into the abdomen. To overcome the retracting limitations of currently available endoscopes, the authors used an extra-long 5-mm articulating retractor placed into the abdomen via a separate colpotomy made under direct vision using the flexible endoscope in a retroflexed position. Endoscopically placed clips were used for control of both the cystic duct and the artery. These techniques obviated the need for any transabdominally placed instruments or needles. This patient was the first to undergo a completely NOTES cholecystectomy at the authors’ institution, and to their knowledge, in the United States. She was discharged on the day of surgery and at this writing has not experienced any complication after 1 month of follow-up evaluation. Performance of NOTES transvaginal cholecystectomy without aid of laparoscopic or needleoscopic instruments is feasible and safe for humans. Additional experience with this technique are required before studies comparing it with standard laparoscopy and hybrid techniques are appropriate.     

Natural orifice translumenal endoscopic surgery (NOTES) partial nephrectomy in a porcine model

Background  

This study aimed to evaluate the feasibility of natural orifice translumenal endoscopic surgery (NOTES) transgastric partial nephrectomy without hilar clamping in a porcine model.     

经阴道混合自然腔道内镜肾切除术(附光盘)

经自然腔道内镜手术(NOTES)以其创伤更小、恢复更快、美容效果更佳的优势,正成为外科手术发展的新方向、新选择。自2010年5月以来,我中心对经阴道NOTES技术进行了一系列探索,逐步完成了从混合NOTES向纯NOTES的过渡。现阶段因受到器械和操作技术等因素的限制,泌尿外科NOTES临床应用多集中在混合NOTES方面,此技术安全、可行,且对女性性功能和生育功能无影响,是已发展成熟的技术,值得临床选用。本文将详细介绍经阴道混合NOTES肾切除术。     

Pure ‘natural orifice transluminal endoscopic surgery’ for transvaginal nephrectomy in the porcine model

OBJECTIVES

To determine the technical feasibility and reproducibility of pure natural orifice transluminal endoscopic surgery (NOTES) transvaginal nephrectomy using NOTES‐specific instrumentation, with no transabdominal assistance.

MATERIALS AND METHODS

Five female farm pigs (mean weight 45 kg) had a right NOTES nephrectomy, using a single‐channel gastroscope in the first three pigs and a dual‐channel gastroscope in the remaining two. The peritoneal cavity was accessed through the posterior fornix of the vagina. Dissection was started at the lower pole of the kidney, and the ureter was retracted laterally and followed towards the hilum. An XL articulated 60 cm endo‐GIA stapler (US Surgical, Norwalk, CO, USA), inserted transvaginally via a separate vaginal incision, was used for tissue retraction and renal hilar transection. The kidney was freed, entrapped in an impermeable sac, and extracted intact transvaginally.

RESULTS

All five procedures were successful with no addition of a transabdominal laparoscopic port or open conversion. The total operative duration decreased from 200 min in the first pig to 60 min in the last (mean 113 min); the mean blood loss was <50 mL, the mean kidney length was 13.9 cm and the weight was 142 g. There were no intraoperative complications; at autopsy, there was no pelvic or bowel injury.

CONCLUSIONS

Pure NOTES transvaginal nephrectomy is feasible in the porcine model. It has the potential of a less morbid approach, providing truly scar‐less surgery. Further development of instrumentation is necessary.     

Transvaginal natural orifice transluminal endoscopic surgery (NOTES)-assisted laparoscopic adrenalectomy: first clinical experience

Background

This study aimed to describe the initial clinical experience of transvaginal natural orifice transluminal endoscopic surgery (NOTES)-assisted laparoscopic adrenalectomy (TNLA) and to evaluate its feasibility and efficacy.

Methods

Between May and December 2010, 11 consecutive women were subjected to TNLA for adrenal tumors at the authors?? center. With the patient under general anesthesia, a 5-mm trocar and a 10-mm trocar were inserted in the umbilical edge for conventional operating apparatus, and a 10-mm trocar was inserted in the posterior vaginal fornix for a conventional 30o laparoscope. Dissection was performed according to the method of a standard laparoscopic adrenalectomy. The adrenal gland, its tumor, or both were put into a homemade bag and then removed via the incision of the posterior vaginal fornix after complete resection.

Results

A total of 11 TNLAs were performed in this series. Only one conversion to open surgery was performed for one patient with Cushing disease, who was subjected to a splenectomy synchronously for an injury of the spleen. Except for this patient, no patients required a blood transfusion. The median operative time was 102?min (range 80?C310?min), and the median estimated blood loss was 80?ml (range 30?C800?ml). The median size of the mass in terms of the largest diameter was 4.7?cm (range 2.2?C6.6?cm). There was no difference between pre- and postoperative median Female Sexual Function Index (FSFI) total scores (P?=?0.102). All the patients except the one who had conversion to open surgery were very satisfied with the cosmetic result.

Conclusions

The findings show TNLA to be a feasible and effective surgical technique that results in excellent cosmesis. It may be an alternative technique for the treatment of properly selected female patients with adrenal tumor.     

Transgastric cecectomy in canine models: natural orifice transluminal endoscopic surgery (NOTES)

Background  

Natural orifice transluminal endoscopic surgery (NOTES) for bowel resection is a challenging procedure. We studied the feasibility and safety of NOTES by performing cecectomy in dogs, which is equivalent to simple bowel resection in man.     

Transvesical natural orifice transluminal endoscopic surgery (NOTES) nephrectomy with kidney morcellation: a proof of concept study

Study Type – Therapy (case series) Level of Evidence 4 What's known on the subject? and What does the study add? Until now, the transvaginal approach has been the only method of removing larger specimens from the abdominal cavity using natural orifice transluminal endoscopic surgery. There has been no means of extracting larger specimens in men and the means are restricted even in women, particularly in young women. The present study shows that the difficulty of large specimen retrieval can be overcome, irrespective of the diameter of the chosen port, through natural orifices using morcellation.

OBJECTIVE

• ? To show, in a porcine model, the feasibility of a complete transvesical natural orifice transluminal endoscopic surgery (NOTES) nephrectomy with kidney extraction after morcellation through the same port.

MATERIALS AND METHODS

• ? Transvesical nephrectomy and morcellation were performed in six pigs at Minho University, Braga, Portugal after institutional review board approval.
• ? The transvesical port and the cystotomy were created under the guidance of a ureteroscope, while the remaining steps were done under the guidance of an operating telescope.
• ? Dissection of the renal vessels and kidney was performed using dissection grasping forceps and a vessel sealing system (LigaSure^?; Covidien, Mansfield, MA, USA) and morcellation was done using a Piranha^? morcellator (Richard Wolf, Knittlingen, Germany).

RESULTS

• ? There were no complications related to the creation of transvesical access.
• ? The image provided by the telescope was superior to that of the ureteroscope, especially underwater. Morcellation was quick and effective, with the support of a fixing needle through the abdominal wall, designed to fix the kidney, after laceration of a bowel loop occurred in the first experiment.
• ? It was found that technical improvements are needed to ensure safety of NOTES morcellation.

CONCLUSIONS

• ? Kidney morcellation after nephrectomy, using a natural orifice exclusively, is feasible.
• ? Despite technical limitations, this proof of concept study can be regarded as a potential step towards the application of NOTES in urology.

     

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.     

Intramural acellular porcine dermal matrix (APDM)-assisted gastrotomy closure for natural orifice transluminal endoscopic surgery (NOTES)

Background

A highly reliable and safe means of gastric closure for natural orifice transluminal endoscopic surgery (NOTES) has yet to be developed. The authors have previously described the self-approximating transluminal access technique (STAT) as a means for gastrotomy closure in transgastric surgery. It has yet to be determined whether biologic mesh can be utilized in facilitating gastrotomy closure via STAT. The aim of this study was to determine the feasibility of implanting an acellular porcine dermal matrix (LifeCell) into the STAT tunnel and investigate whether it will become incorporated into the submucosal plane of the STAT tunnel.

Methods

Five pigs underwent transgastric left uterine horn resection utilizing STAT. For closure, the acellular porcine dermal matrix was implanted within the submucosal plane, occluding the seromuscular incision. The mucosal incision was then closed over the matrix with endoscopically placed clips. Necropsy was performed after a 3 week survival period. Histopathological evaluation of the tunnel and matrix was performed.

Results

The matrix was successfully implanted in all five animals. Average OR time was 151 ± 68 min. Average time to anchor and embed the matrix within the tunnel was 4 ± 1 and 9 ± 12 min, respectively. There was one duodenal perforation related to a balloon occlusion device. Postoperative course was unremarkable; the average weight gain at 3 weeks was 22 ± 5 lbs. On necropsy, one animal had some protrusion of the matrix at the serotomy, with adhesions to small bowel and liver. Histopathology revealed one clinically insignificant microabscess but otherwise demonstrated local inflammation and fibrovascular ingrowth into the matrix.

Conclusions

The porcine dermal matrix can be successfully implanted within the gastric submucosal plane and evidence of incorporation into the gastric wall by 3 weeks was demonstrated.     

经自然腔道内镜手术在腹部外科手术中的发展与展望

瘢痕一直被认为是手术后的必然产物。为了在手术中达到充分的暴露,大手术常会产生大瘢痕。但自20世纪80年代开始,随着腹腔镜微创外科技术的不断发展,人们意识到大手术也同样可以只留下小瘢痕,而且具有病人痛苦小、术后恢复快和美观等优点。人们逐渐改变了对以往手术入路的认识,"微创"才是未来外科发展的方向。近年来,一种挑战传统外科观念的全新技术吸引了腹腔镜和内镜医师们的极大兴趣,成为研究和争议的焦点,这就是被称为"无瘢痕手术"的经自然腔道内镜手术(natural orifice translumenal     

Quantifying mental workloads of surgeons performing natural orifice transluminal endoscopic surgery (NOTES) procedures

Background

During natural orifice transluminal endoscopic surgery (NOTES), surgeons often have difficulties orienting the surgical view and manipulating instruments accurately, which increases their level of mental and physical fatigue. This study quantified mental workload by measuring the spared mental resources of surgeons performing NOTES training tasks.

Methods

Assessment of mental workload was conducted in both a benchtop and a hybrid animal model. Using the benchtop model, surgeons were required to pass a ring as many times as possible in 6?min. Using the hybrid model, surgeons were required to dissect the gallbladder. While performing those primary tasks, the surgeon was required to identify true visual signals among many false signals displayed on an adjacent monitor. They were asked to repeat the trials using laparoscopy. The surgeons’ performance on the primary and secondary tasks using the NOTES and laparoscopic approaches were recorded and compared.

Results

The nine surgeons who completed the trials in the benchtop model successfully transferred 13?±?4 rings between targets using laparoscopy compared with a mean of 1.2?±?1.0 rings transferred using NOTES (P?P?=?0.005). Using the hybrid model, 10 surgeons achieved a 55% accuracy rate performing the laparoscopic task. This was found to be significantly higher (P?=?0.006) than when the task was performed using the NOTES platform (39%).

Conclusion

The results showed that performance of a task using the NOTES platform increases surgeons’ mental workload. Because difficulty performing NOTES is associated with flexible endoscopy, the authors expect that new operating systems providing stable platforms will help to decrease the mental workload of surgeons and enhance eye–hand coordination in performing NOTES.     

Natural orifice translumenal endoscopic surgery (NOTES) renal cryoablation in a porcine model

OBJECTIVE

To present our laboratory experience with natural orifice translumenal endoscopic surgery (NOTES) renal cryoablation.

MATERIALS AND METHODS

In two female farm pigs, we performed four procedures of NOTES renal cryoablation. In each pig, NOTES was performed through a transgastric approach and a transvaginal approach for each kidney, respectively. The pig was placed in the flank position and pneumoperitoneum obtained using a transabdominal Veress needle. In the first pig, we started with the left kidney with a transgastric approach: a dual‐channel video gastroscope (Olympus, Tokyo, Japan) was used, the stomach wall was punctured using a needle‐knife, a guidewire was passed into the abdominal cavity and the access dilated using a controlled radial expansion balloon. The bowel was mobilized medially and the Gerota’s fascia overlying the upper pole was dissected. Under direct endoscopic vision, a cryoablation probe was introduced percutaneously into the anterior upper pole of the kidney. The pig was then flipped to the right flank position and a transvaginal approach was used: the gastroscope was introduced through the posterior fornix of the vagina. For the second pig, we performed initially a transgastric right‐side cryoablation then a transvaginal left‐side cryoablation as described for the first pig.

RESULTS

All four procedures were performed successfully, with no intraoperative complications. No additional laparoscopic ports or open conversions were necessary. The vision of the kidney and the ice‐ball was adequate for all cases. The mean operative duration was 83 min. Stomach closure was tested watertight, and there were no abdominal or pelvic injuries found at autopsy.

CONCLUSIONS

NOTES can provide adequate minimal surgical dissection for safe and effective percutaneous renal cryoablation under direct videoscopic monitoring at kidney locations otherwise not accessible percutaneously. Both transgastric and transvaginal approaches can be used effectively for renal cryoablation providing a minimally invasive scar‐less surgery.     

Gastric lymphatic mapping for sentinel node biopsy by natural orifice transluminal endoscopic surgery (NOTES)

Background  Sentinel node biopsy is proposed as sufficiently reliable in determining the lymph node status of early gastric cancer to justify curtailed resection margins if negative. Its performance by natural orifice transluminal endoscopic surgery (NOTES) could therefore expand the patient cohort able to undergo solely endoscopic resection of their primary. Methods  A transvaginal NOTES technique was utilized in six pigs (mean weight 30 kg). The posterior colpotomy and pneumoperitoneum was created by a standard double-channel flexible videoendoscope which was then used to perform peritoneoscopy. Concomitant gastroscopy allowed selection of a site along the greater curvature for lymphatic mapping by submucosal injection of methylene blue (3 ml). Furthermore, torque upon this endoscope allowed the posterior surface of the stomach and retrogastric space to become accessible to the transvaginal endoscope. In surveying the mapping in vivo, the intraperitoneal scope could follow blue-stained efferent lymphatic channels to their first-order draining nodes (i.e., sentinel nodes). Conventional instruments worked down the scope’s channels were then used to perform the excisional biopsy. At procedure end, the animals underwent immediate laparotomy to ensure the safety and adequacy of the procedure. Results  Each procedure was technically successful. Colpotomy, pneumoperitoneum, and peritoneoscopy were promptly achieved (mean 8 min). Post injection, blue efferent lymphatic channels were immediately appreciable in every animal. Five animals had sentinel nodes in their retropyloric region while the last mapped cephalad towards the esophagogastric junction. Two animals had alternative drainage channels identifying additional sentinel nodes. All blue nodes were dissected cleanly by the intraperitoneal scope and retrieved intact per vaginam. Mean lymphadenectomy time was 19 min. At laparotomy, there was no hematoma, ongoing hemorrhage, or visceral injury in any pig. There were no residual, missed stained nodes or channels. Conclusion  NOTES sentinel node biopsy for the stomach is technically accomplishable in this experimental model. This proof of concept should encourage serious consideration of its applicability to clinical practice. Electronic supplementary material  The online version of this article (doi:) contains supplementary material, which is available to authorized users.     

Deep sedation in natural orifice transluminal endoscopic surgery (NOTES): a comparative study with dogs

Background

Natural orifice transluminal endoscopic surgery (NOTES) has been mostly performed with the animal under general and inhalational anesthesia (IA-NOTES). To date, NOTES using propofol sedation (PS-NOTES) has not been investigated. This study aimed to assess the feasibility and safety of PS-NOTES for transgastric oophorectomy with carbon dioxide insufflation and to compare its success rates with those of conventional IA-NOTES.

Methods

In this prospective randomized study, NOTES oophorectomy was performed for 19 female dogs randomized to two conditions: PS (study group) and IA (control group). Sedation success rates (ability to visualize and resect ovaries without converting to IA), operative success rates (ability to resect and retrieve both ovaries in full using only NOTES), and vital parameters including hemodynamic and respiratory changes were documented.

Results

In the PS-NOTES group (n?=?9), the sedation success rate was 100?%. The operative success rate was 67?% (6 of 9 animals) compared with 80?% (8 of 10 animals) in the IA-NOTES group. No purposeful movement occurred during surgical manipulation and no respiratory or cardiovascular complications in occured the PS group. Heart rate (HR) and end-tidal carbon dioxide (ETCO₂) were significantly higher in the PS group than in the IA group. Blood pressure (BP) was significantly higher in the PS group only during the middle part of the procedure. Only mild respiratory depression was noted in the PS group, as indicated by elevated but acceptable ETCO₂. Elevations in BP and HR are thought to be related to elevated CO₂ but did not appear to have an adverse impact on the course of the procedure. Recovery was uneventful for all the animals.

Conclusion

The use of PS-NOTES appears to be feasible, resulting in outcomes comparable with those for IA in dogs. Further studies are needed to determine the applicability of this concept in human NOTES.