NOTES transvaginal cholecystectomy: preliminary clinical application

Background Natural orifice translumenal endoscopic surgery (NOTES) is an emerging concept in the recent literature that could lead to potential benefits in clinical applications. Restricted to animal experiments, however, human procedures have not yet been published. Because of the technical and ethical challenges involved in perforation and closure of a healthy organ—as is also seen in operating via the transgastric route—and because of the lack of understanding of the physiopathology and infection risk with these approaches, they have not been applied in the clinical setting. Thus the present study, based on previous animal experiments, describes preliminary clinical application in four cases of transvaginal NOTES cholecystectomy, and discusses safety, feasibility, and potential benefits of the method. Methods Preliminary acute and survival animal experiments developed by the NOTES Research Group at our institution solved such technical problems for transvaginal NOTES as spatial orientation, insufflation, and instrumentation, making possible the introduction of NOTES as a clinical application. The trials were approved by ethics committee of our institution, and informed consent was obtained from all patients. Since 13 March 2007, four female patients with elective surgical indication for cholecystectomy have undergone transvaginal NOTES cholecystectomy. All intraoperative and postoperative parameters were documented. Vaginal access was achieved under direct vision with conventional instruments, and a 2-channel colonoscope was inserted into the abdominal cavity. After endoscopic insufflation to achieve pneumoperitoneum with CO₂, instruments were inserted through and alongside a colonoscope, allowing successful NOTES cholecystectomy in all patients, with vaginal extraction of the gallbladder. The vaginal wound was closed by direct vision using conventional instruments. Results The procedure was successful in all patients, with operative time of 45–115 min. Patients experienced low need for postoperative analgesia. Free oral intake was permitted 2 h after the procedure. There were no postoperative complications, and patients were discharged, according to the study protocol, 48 h after the procedure. Conclusions Preliminary results showed the feasibility and safety of the transvaginal NOTES method in this small initial study population. The technique, developed in our institution, and not transgastric NOTES, may be the preferred approach to serve as the basis for clinical studies.     

Reliable gastric closure after natural orifice translumenal endoscopic surgery (NOTES) using a novel automated flexible stapling device

Background  Reliable closure of the translumenal incision is one of the main challenges facing natural orifice translumenal endoscopic surgery (NOTES). This study aimed to evaluate the use of an automated flexible stapling device (SurgASSIST) for closure of the gastrotomy incision in a porcine model. Methods  A double-channel gastroscope was advanced into the stomach. A gastric wall incision was made, and the endoscope was advanced into the peritoneal cavity. After peritoneoscopy, the endoscope was withdrawn into the stomach. The SurgASSIST stapler was advanced orally into the stomach. The gastrotomy edges were positioned between the opened stapler arms using two endoscopic grasping forceps. Stapler loads with and without a cutting blade were used for gastric closure. After firing of the stapler to close the gastric wall incision, x-ray with contrast was performed to assess for gastric leakage. At the end of the procedure, the animals were killed for a study of closure adequacy. Results  Four acute animal experiments were performed. The delivery and positioning of the stapler were achieved, with technical difficulties mostly due to a short working length (60 cm) of the device. Firing of the staple delivered four rows of staples. Postmortem examination of pig 1 (when a cutting blade was used) demonstrated full-thickness closure of the gastric wall incision, but the cutting blade caused a transmural hole right at the end of the staple line. For this reason, we stopped using stapler loads with a cutting blade. In the three remaining animals (pigs 2–4), we were able to achieve a full-thickness closure of the gastric wall incision without any complications. Conclusions  The flexible stapling device may provide a simple and reliable technique for lumenal closure after NOTES procedures. Further survival studies are currently under way to evaluate the long-term efficacy of gastric closure with the stapler after intraperitoneal interventions. Presented in part at the Society of American Gastrointestinal Endoscopic Surgeons (SAGES) Annual Meeting, Las Vegas, Nevada, April 2007.     

Natural orifice translumenal endoscopic surgery (NOTES): dissection for the critical view of safety during transcolonic cholecystectomy

Background  Natural orifice translumenal endoscopic surgery (NOTES), an emerging field in minimally invasive surgery, is driving the development of new technology and techniques. The NOTES approach has several proposed benefits including potentially decreased abdominal pain, wound infections, and hernia formation [1–4]. Cholecystectomy is one of the most commonly performed NOTES procedures to date [5–7]. To perform a safe cholecystectomy and reduce potential bile duct injuries, the cystic duct and artery must first be identified. Establishing this critical view of safety before ligation and division has been shown to reduce bile duct injuries associated with laparoscopic cholecystectomy [8]. This video shows that the critical view of safety can be attained with endoscopic dissection. Methods  In the porcine model, transcolonic peritoneal access is gained using an endoscopic needleknife and balloon dilator. Once orientation is established, the gallbladder is retracted using percutaneous T-tags. The cystic duct and artery bundle are identified and then meticulously dissected using endoscopic graspers, hook cautery, biopsy forceps, and scissors. The individual cystic duct and artery are isolated and identified, establishing the critical view of safety. Endoscopic clip ligation and division are then performed, and the gallbladder is dissected free. Conclusions  Dissection of the critical view of safety can be performed in a completely endoscopic fashion using appropriate instrumentation. By achieving this critical view, the incidence of biliary injury during NOTES should be minimal and similar to the incidence of biliary injury during laparoscopic surgery. While completing this procedure, we identified several remaining technical limitations and deficiencies. Endoscopic retraction of tissue still is challenging with currently available instrumentation. Hemostatic endoscopic clips are not currently available for cystic artery and duct ligation. With the development of such instruments, cholecystectomy and other NOTES procedures will become technically more feasible. Electronic supplementary material  The online version of this article (doi:) contains supplementary material, which is available to authorized users.     

Transgastric cholecystectomy: From the laboratory to clinical implementation

After the first report by Kalloo et al on transgastric peritoneoscopy in pigs, it rapidly became apparent that there was no room for an under-evaluated concept and blind adoption of an appealing (r)evolution in minimal access surgery. Systematic experimental work became mandatory before any translation to the clinical setting. Choice and management of the access site, techniques of dissection, exposure, retraction and tissue approximation-sealing were the basics that needed to be evaluated before considering any surgical procedure or study of the relevance of natural orifice transluminal endoscopic surgery (NOTES). After several years of testing in experimental labs, the revolutionary concept of NOTES, is now progressively being experimented on in clinical settings. In this paper the authors analyse the challenges, limitations and solutions to assess how to move from the lab to clinical implementation of transgastric endoscopic cholecystectomy.     

Needlescopic cholecystectomy: lessons learned in 10 years of experience.

OBJECTIVES: Needlescopic cholecystectomy (NC) is a refinement of laparoscopic cholecystectomy (LC) using 2-mm instruments compared with the standard 5-mm and 10-mm ports. We review our experience with needlescopic cholecystectomy. METHODS: From 1994 to 2004, 303 patients underwent NC. All patients were operated on using 2-mm instruments and one 10-mm trocar for the laparoscope. The characteristics of patients, total operation time, complications, postoperative pain, and hospital course were documented. RESULTS: Patients' average age was 41.86 years; 262 were female and 41 were male. Mean BMI was 25.7. Mean length of surgery was 59.33 minutes. Intraoperative cholangiography was performed in all cases. Mean blood loss was 14.88 mL. One intraoperative complication occurred. Mean hospital stay was 22.68 hours. Postoperative pain was measured on a 0-10 pain scale; on day 0 it was 4.4 and on the first day it was 1.7. Analgesic doses required were 0 doses in 6.89%, 1 in 20.68%, 2 in 24.13%, 3 in 34.48%, 4 in 13.79%, and > 4 doses was not required. No postoperative complications occurred. At 3-month follow-up, patient satisfaction was 100%, and in 99% of patients scars were imperceptible. CONCLUSIONS: NC is safe and feasible without increased operative risk, with better cosmetic results, less pain, and good acceptance among patients.     

SPIDER surgical system for urologic procedures with laparoendoscopic single-site surgery: from initial laboratory experience to first clinical application

This case study describes our initial laboratory experience using the SPIDER surgical system (TransEnterix, Morrisville, NC, USA) for laparoendoscopic single-site surgery (LESS) urologic procedures and reports its first clinical application. The SPIDER system was tested in a laboratory setting and used for a clinical case of renal cyst decortication. Three tasks were performed during the dry lab session, and different urologic procedures were conducted in a porcine model. The time to complete the tasks and penalties were registered during the dry lab session. Perioperative outcomes and subjective assessment by the surgeons were registered.The surgeons had a positive experience with the SPIDER system, with a mean overall score of 3.6 (on a scale of 1-5). The surgeons were able to gain proficiency in performing tasks regardless of their level of expertise. The highest scores recorded were for ease of device insertion, instrument insertion and exchange, and triangulation. The lowest scores were for retraction. During the clinical case, the platform provided good triangulation without instrument clashing. However, retraction was challenging because of the lack of strength and precise maneuverability with the tip of the instruments fully deployed. The SPIDER system offers intuitive instrument maneuverability and restored triangulation without external instrument clashing. Further refinements are awaited to define its role in the urologic LESS armamentarium.     

Hybrid transvaginal cholecystectomy, NOTES, and minilaparoscopy: analysis of a prospective clinical series

Introduction  Natural orifice transluminal endoscopic surgery (NOTES) makes it possible to perform intraperitoneal surgical procedures with a minimal number of access points in the abdominal wall. It is not yet possible to perform these interventions without the help of abdominal wall entryways, so these procedures are hybrids, a fusion of minilaparoscopy and transluminal endoscopic surgery. In this paper we present a prospective clinical series of 15 patients who underwent transvaginal hybrid cholecystectomy for cholelithiasis. Methods  This was a prospective clinical series of 15 consecutive female patients, nonrandomly chosen and without a control group, who underwent a fusion transvaginal NOTES and minilaparoscopy procedure with two entryways for cholelithiasis. One was umbilical and measured 5 mm in diameter, and the other was in the right upper quadrant and measured 3 mm in diameter. Results  The scheduled surgical intervention was performed on the 15 patients in whom it had been indicated. There were no intraoperative complications. One patient had mild hematuria that resolved in less than 12 h; there were no other complications after average follow-up of 124 days. Nine patients were discharged in 24 h, and two were discharged less than 12 h after the procedure. Discussion  Hybrid transvaginal cholecystectomy is a good surgical model for minimally invasive surgery, a combination of NOTES and minilaparoscopy. It can be performed in surgical settings where laparoscopy is practised regularly, using the instruments normally used for endoscopy and laparoscopic surgery. Owing to the reproducibility of the intervention and the ease of vaginal closure, hybrid transvaginal cholecystectomy will permit further development of NOTES in the future.     

Natural orifice translumenal endoscopic surgery (NOTES) applied totally to sigmoidectomy: an original technique with survival in a porcine model

Background  Natural orifice translumenal endoscopic surgery (NOTES) continues to evolve. This study investigated the feasibility and outcome of performing localized sigmoidectomy in its entirety via NOTES. Methods  A survival study of five male minipigs (mean weight, 30 kg) was conducted. After anesthesia, a gastrotomy was created by a per os double-channel endoscope, and full peritoneoscopy was performed. A Berci needle then was inserted transparietally to allow maintenance and monitoring of the pneumoperitoneum. Using a transanal probe to facilitate intestinal retraction, the mesentery was dissected with instruments worked through the channels of the transgastric endoscope. The anvil of a circular stapler then was passed per anum into the colon above the point of intended transection. A penetrating transrectal trocar was placed to allow entry of a linear stapler into the peritoneum through a colotomy, and the sigmoid was cross-stapled proximally. The strut of the anvil then was snugged into a colotomy made at this staple line. The specimen was delivered via the anus by a “pull-through” technique. The distal sigmoidal margin was cross-stapled extracorporeally, ensuring that the colotomy was included within the specimen. Retrograde passage of the circular stapler head per anus allowed colocolonic reanastomosis by its mating with the anvil already in situ. The gastrotomy was closed with a previously validated prosthesis. Postoperatively, all the animals were recovered and monitored for well-being during convalescence. Endoscopy (gastroscopy and sigmoidoscopy), laparoscopy, and laparotomy were performed on postoperative day 14 as follow-up measures. Results  Each operation was satisfactorily completed. The mean operative time was 76 min (range, 44–95 min). All the animals prospered postoperatively. Follow-up examination showed full healing of all anastomoses and gastrotomy sites. There was no evidence of luminal stricturing, peritonitis, or intraabdominal sepsis in any animal. Conclusions  Using this experimental model, colonic resection and reanastomosis can be performed safely within the NOTES format. Presented at S032 NOTES Sigmoid Resection at SAGES, April 9–12, 2008.     

Hydro-Jet assisted laparroscopic cholecystectomy: initial experience in a porcine model.

BACKGROUND AND OBJECTIVES: Hydro-Jet technology has long been used for cutting various materials like metal and wood in the industrial field. In the medical field, this technology has been applied successfully for selective cutting of the parenchyma of the liver. However, to our knowledge, no data exist on the use of the Hydro-Jet technique for laparoscopic cholecystectomy. The purpose of this study was to evaluate a new dissection technique using a high-pressure water stream (Hydro-Jet) and a new dissection probe for laparoscopic cholecystectomy. METHODS: Thirty pigs underwent laparoscopic cholecystectomy. Pigs were randomized to receive either the conventional or Hydro-Jet assisted dissection technique. The feasibility of this technique and the features of surgical dissection were evaluated and compared between the 2 groups. RESULTS: Laparoscopic cholecystectomy was successful in all animals with no need for conversion to open surgery. The mean operative time was 28 and 36 minutes for Hydro-Jet versus conventional dissection, respectively. Complications using the Hydro-Jet and conventional techniques included 6% and 20% gallbladder perforation and 6.5% and 13% liver laceration, respectively. The use of the Hydro-Jet for cholecystectomy had clear technical advantages over conventional dissection. The Hydro-Jet resulted in a selective dissection of fibrous and connective tissue preserving blood vessels for later ligation. Therefore, the dissection was performed in a relatively bloodless field. The ease of dissection using the new bent tipped dissector represents another advantage. Finally, the continuous water flow allowed a clear view for the operator. CONCLUSIONS: This study shows that Hydro-jet dissection represents an excellent alternative to the conventional technique for laparoscopic cholecystectomy. The improved anatomical dissection combined with an almost bloodless operating field secondary to continuous water flow may decrease dissection-related complications.     

NOTES: approach to the liver and spleen

Background  Minimally invasive abdominal surgery means minimal trauma to the abdominal wall, thus reducing postoperative pain and wound complications, and facilitating earlier mobilization and shorter hospitalization in comparison with conventional surgery. Natural orifice translumenal endoscopic surgery (NOTES) has the potential to further reduce the invasiveness of surgery in human patients. Here we report an experimental study of NOTES to access the liver and spleen, discuss its current status, and review the related literature. Methods  The utility of transgastric peritoneoscopy was evaluated using one 15-kg pig and four 8-kg dogs on the basis of acute experiments. Under general anesthesia with endotracheal intubation, a forward-viewing, double-channel endoscope was advanced into the peritoneal cavity through a gastric hole. Liver biopsy from the edge of the liver was performed using routine biopsy forceps. Splenectomy was performed using a laparoscopically assisted procedure, and then the spleen was pulled into the stomach using an endoscopic polypectomy snare after enlargement of the gastric orifice. The animals were then sacrificed and necropsy was performed. Results  There were no complications during incision of the gastric wall and entry into the peritoneal cavity. Peritoneoscopy gave satisfactory visualization of the abdominal cavity in all directions. Liver biopsy was performed successfully without any bleeding and adequate samples were obtained in all cases. Splenectomies were also accomplished uneventfully, except for injury of the splenic parenchyma due to excessive force during pulling into the stomach. Necropsy revealed no particular damage to other intraperitoneal organs related to this transgastric procedure. Conclusion  Although NOTES is a feasible procedure and offers several advantages to patients, surgeons and endoscopists need to resolve several key issues before its clinical introduction for routine surgical work and to establish a training system for NOTES in order to avoid critical complications.     

经脐入路“两孔法”腹腔镜胆囊切除术的临床应用(附11例报告)

目的:探讨经脐入路"两孔法"腹腔镜胆囊切除术(laparoscopic cholecystectomy,LC)的可行性及应用价值。方法:为11例胆囊息肉样病变患者行经脐入路"两孔法"LC。结果:手术时间40～55min,平均46min,术中出血10～15ml,平均12ml。无并发症发生,腹部无明显手术疤痕。结论:经脐入路"两孔法"LC治疗胆囊良性疾病,手术时间较长,技术要求更高,但更具微创性,美容效果更佳,尤其适合有较高美容要求的患者。     

胆囊切除致胆管损伤210例诊治经验

目的 探讨医源性胆管损伤的诊断、治疗和预防方法。方法 回顾性分析1990—2006年湖南省人民医院肝胆科收治的210例胆囊切除至胆管损伤的临床资料。结果 胆囊切除时胆囊三角区解剖不清103例，占49％（103／210）。医源性胆管损伤的诊断主要依赖于临床症状、体征、腹部穿刺和影像学检查，B超是使用最普遍的检查手段，确诊率为85％（126／149），MRCP可显示损伤部位胆管的平面、长度及胆管是否变异，确诊率达100％（45／45）。根据损伤的平面将损伤分为6个类型，以Ⅲ型最多见，占81％（171／210）。176例获随访平均3年7个月，效果优良率达88％（154／176）。结论 切断胆囊管前先辨清胆总管、肝总管，胆囊切除后再辨清胆总管、肝总管是否完整，这是预防医源性胆管损伤的关键，根据损伤类型决定再手术时机及手术方式。     

静脉全麻复合硬膜外麻醉用于腹腔镜胆囊切除术的临床观察

目的:探讨静脉全麻复合硬膜外麻醉用于腹腔镜胆囊切除术(laparoscopic cholecystectomy,LC)的麻醉效果,并与单纯静脉全麻比较。方法:随机将LC60例患者分为对照组(静脉全麻)与观察组(静脉全麻复合硬膜外麻醉),每组30例。记录麻醉前、麻醉后(气管插管后或硬膜外平面固定后期气腹前)、气腹后5min及术毕时的SBP、DBP、HR、呼之睁眼时间、拔管时间、术后恶心呕吐(PONV)发生例数及8h内的平均VAS评分、两组异丙酚的用量。结果:两组患者术中血流动力学变化无显著性差异;观察组患者苏醒质量、PONV、8h平均VAS评分及异丙酚量与对照组有显著性差异。结论:LC全麻复合硬膜外麻醉对循环和呼吸的干扰小,清醒质量高且经济安全。     

腹腔镜胆囊动脉入路与传统入路胆囊切除术的对比分析

目的探讨分析腹腔镜胆囊动脉入路与传统入路胆囊切除术的临床资料。 方法选取2015年3月至2017年5月行腹腔镜胆囊切除术的临床病例240例,根据不同的手术入路方式分为动脉入路组与传统组,动脉入路组患者行腹腔镜下胆囊动脉入路胆囊切除术,传统组患者行腹腔镜下传统入路胆囊切除术,每组各120例。采用SPSS 18.0统计软件对数据进行分析,两组的手术时间、术中出血量、住院时间计量资料以( ±s)表示,采用独立t检验,术后并发症的发生率采用χ²检验,以P<0.05为差异有统计学意义。 结果动脉入路组手术时间和住院时间分别为(43.8±11.1) min和(6.3±2.1) d,与传统组比较,差异无统计学意义(P>0.05);动脉入路组的术中出血量为(5.2±3.3) ml,明显少于传统组(17.4±7.4) ml,差异有统计学意义(P＝0.000);动脉入路组与传统组患者术后并发症发生率分别为2.5%和5.8%,两组差异无统计学意义(P>0.05),但动脉入路组未出现胆管损伤病例。 结论腹腔镜下胆囊动脉入路胆囊切除术可精确胆囊三角解剖,避免胆管损伤,降低术后并发症的发生。