Natural Orifice Translumenal Endoscopic Surgery (NOTES) Transvaginal Cholecystectomy in a Morbidly Obese Patient

Transvaginal natural orifice translumenal endoscopic surgery (NOTES) is a new diagnostic and potentially therapeutic method of surgical endoscopy. The first case of NOTES transvaginal cholecystectomy in a morbid obese patient in the literature is described. IRB approval was obtained at the institution for transvaginal NOTES clinical trials. A 58-year-old female patient with cholelithiasis, hypertension, and type II diabetes, and BMI of 35.8 kg/m(2) was submitted to the technique. After transvaginal access, a two-channel gastroscope was introduced into the abdominal cavity along with a laparoscopic trocar. There were 2 umbilical punctures for use of 3 mm laparoscopic equipment. Operative time was 85 min. There was no use of postoperative analgesia, and the patient was discharged on the third postoperative day. Transvaginal NOTES is a feasible alternative method for cholecystectomy in the morbidly obese, although available technology is limited for natural orifice surgery.     

Pure Natural Orifice Translumenal Endoscopic Surgery (NOTES) Transvaginal Nephrectomy

Natural orifice translumenal endoscopic surgery (NOTES) within urology has largely been limited to experimental animal studies and diagnostic procedures in humans. Attempts to complete a pure NOTES transvaginal nephrectomy have thus far been unsuccessful. We report the first clinical experience with pure NOTES transvaginal nephrectomy.     

Natural Orifice Translumenal Endoscopic Surgery: A Critical Review

Natural orifice translumenal endoscopic surgery (NOTES) involves the intentional puncture of one of the viscera (e.g., stomach, rectum, vagina, urinary bladder) with an endoscope to access the abdominal cavity and perform an intraabdominal operation. Early laboratory work focused on feasibility studies, including such accomplishments as pure transgastric splenectomy and gastrojejunostomy. Contemporary laboratory work is investigating the infectious and immunologic implications of NOTES and honing the tools and techniques required for complex abdominal operations. Today NOTES has entered the clinical arena in a few cases: the first clinical series of transgastric peritoneoscopy has recently been published; multiple groups are accumulating patients in studies of NOTES cholecystectomy, either via the transgastric or transvaginal route; and a series of transgastric appendectomies has been well publicized, yet it remains unpublished. Although clinical NOTES is gaining momentum, the field should remain in check while rigorous laboratory work is performed and cogent clinical trials are undertaken. The zeal for NOTES should not take precedence over the welfare of the patient.     

Surgeon Perceptions of Natural Orifice Translumenal Endoscopic Surgery (NOTES)

Introduction  If proven feasible and safe, Natural Orifice Translumenal Endoscopic Surgery (NOTES) would still need acceptance by surgeons if it were to become a mainstream approach. Methods  Three hundred fifty-seven surgeons responded to a preliminary survey describing NOTES and were asked to rate the importance of various surgical considerations and (assuming availability and safety) if they would choose to undergo and/or perform cholecystectomies by NOTES or laparoscopy and why. Results  The risk of having a complication was considered most important. NOTES was theorized to be riskier and to require greater skill than laparoscopy but to potentially cause less pain and convalescence. Nearly three-fourths (72%) of surgeons expressed interest in NOTES training which correlated with younger age, SAGES membership, minimally invasive surgery specialization, and flexible endoscopic volume. Forty-four percent would like to introduce NOTES cholecystectomy into their practices. Among those not preferring NOTES, 88% would adopt NOTES if data showed improved outcomes over laparoscopy. Finally, only 24% would choose to undergo cholecystectomy themselves by NOTES, believing it to be too new and riskier than laparoscopy. Discussion  The risk of having a complication is the greatest concern among surgeons, and safety will affect NOTES acceptance. Conclusion  The results of this survey seem to justify more focused future investigations. Poster presentation at Digestive Disease Week, Washington, D.C., May 21, 2007.     

经自然腔道内镜手术实验研究

目的探讨NOTES完成动物腹部多种手术成功与失败的原因,为其应用于临床提供实验依据。方法回顾分析2007年8月～2009年9月完成的全部动物实验数据。研究分为急性实验和存活实验2部分,采用雌性小型猪和成年杂种犬,分别开展了单纯NOTES和腹腔镜辅助的NOTES。进行诊断性腹腔探查和肝脏活检术,治疗性胆囊切除、输卵管结扎切除、卵巢切除、脾切除和胃空肠吻合等腹部手术。记录术中和术后并发症的发生情况,以及操作过程中遇到的技术难题。结果采用37只小型猪和16只杂种犬,完成急性实验22例,存活实验31例。共开展各种NOTES手术91例次,其中单一经胃路径25例次,单一经结肠路径8例次,经胃和结肠联合路径16例次,经胃和阴道联合路径6例次,传统腹腔镜辅助经胃路径26例次,单孔腹腔镜辅助经胃路径10例次。完成诊断性腹腔探查术33例,成功率100%（33/33）,肝脏活检术11例,成功率100%（11/11）,输卵管结扎切除术11例,成功率100%（11/11）,卵巢切除术6例,成功率100%（6/6）,胆囊切除术27例,成功率44.4%（12/27）。另行脾切除术1例和胃空肠吻合术2例,均未成功。总的并发症发生率为39.6%（21/53）,其中穿孔8例,脏器损伤5例,出血4例,腹腔感染3例,腹压过高导致动物死亡1例。结论NOTES用于诊断性腹腔探查和简单治疗是安全有效的,但完成腹部较复杂的手术尚不可行。腹腔镜辅助NOTES的方法或许是此项技术从动物实验过渡到临床应用的桥梁。     

Complete Endoscopic Closure of Gastrotomy After Natural Orifice Translumenal Endoscopic Surgery Using the NDO Plicator

Background The NDO Plicator is a device developed for endoscopic treatment of gastroesophageal reflux disease (GERD) by approximation of tissues together with a double-pledgeted U-stitch. It was theorized that this device may facilitate transgastric natural orifice translumenal endoscopic surgery (NOTES) because closure of the transgastric defect remains a key component for advancement of this new technology. Methods A standardized 12-mm gastrotomy was created endoscopically in four pigs using a combination of needle-knife cautery and balloon dilation. As the endoscope was removed, a Savary soft-tipped wire was introduced into the stomach, and the NDO Plicator was subsequently advanced over the wire. Each defect was identified, and the device was positioned. If necessary, the Plicator’s tissue grasper was used to hold the superior aspect of the gastrotomy and bring the opposed borders of the defect within the jaws of the device. The device was fired three times, leaving three pledgeted suture bundles to close the gastric defect. After closure, each animal was explored, and the integrity of the closure was assessed. The animals underwent in vivo contrast fluoroscopy and ex vivo burst pressure testing studies for assessment of leakage at the closure site. Results The first animal was used to test feasibility, refine techniques, and develop a standard procedure. All of the next three animals studied showed complete sealing of the gastrotomy site without evidence of contrast extravasation on multiplanar fluoroscopic imaging. Each stomach was excised, submerged in water, and subjected to a pressurized air leak test. No leaks were noted until pressures exceeded 55 mmHg. Conclusion This study supports the use of the NDO Plicator for closure of standardized gastric defects in a porcine model. In addition to closing NOTES gastrotomies, the NDO Plicator may be a particularly useful tool for obtaining complete closure of gastric perforations and anastomotic leaks, and for performing stomal reduction after gastric bypass procedures. The mechanical properties of a closure are not the only factor determining whether a leak will develop. Tissue opposition, ischemia, and tension are important factors that are not easily or reliably measured. The physiologic relevance of gastric bursting pressure is not known. Therefore, corollary animal studies with longer-term evaluation are necessary before research proceeds to clinical trials. This article was presented at the 2007 Scientific Session of the Society of American Gastrointestinal and Endoscopic Surgeons (SAGES) Annual Meeting in April 2007 in Las Vegas, Nevada.     

Natural Orifice Translumenal Endoscopic Surgery with a miniature in vivo surgical robot

Background  The application of flexible endoscopy tools for Natural Orifice Translumenal Endoscopic Surgery (NOTES) is constrained due to limitations in dexterity, instrument insertion, navigation, visualization, and retraction. Miniature endolumenal robots can mitigate these constraints by providing a stable platform for visualization and dexterous manipulation. This video demonstrates the feasibility of using an endolumenal miniature robot to improve vision and to apply off-axis forces for task assistance in NOTES procedures. Methods  A two-armed miniature in vivo robot has been developed for NOTES. The robot is remotely controlled, has on-board cameras for guidance, and grasper and cautery end effectors for manipulation. Two basic configurations of the robot allow for flexibility during insertion and rigidity for visualization and tissue manipulation. Embedded magnets in the body of the robot and in an exterior surgical console are used for attaching the robot to the interior abdominal wall. This enables the surgeon to arbitrarily position the robot throughout a procedure. Results  The visualization and task assistance capabilities of the miniature robot were demonstrated in a nonsurvivable NOTES procedure in a porcine model. An endoscope was used to create a transgastric incision and advance an overtube into the peritoneal cavity. The robot was then inserted through the overtube and into the peritoneal cavity using an endoscope. The surgeon successfully used the robot to explore the peritoneum and perform small-bowel dissection. Conclusion  This study has demonstrated the feasibility of inserting an endolumenal robot per os. Once deployed, the robot provided visualization and dexterous capabilities from multiple orientations. Further miniaturization and increased dexterity will enhance future capabilities. Electronic supplementary material  The online version of this article (doi:) contains supplementary material, which is available to authorized users. Presented at the 2008 Society of American Gastrointestinal and Endoscopic Surgeons (SAGES) Meeting, Philadelphia, Pennsylvania, April 9–12, 2008.     

经自然孔道内镜手术在泌尿外科中的应用

一直以来,泌尿外科医师在经人体自然孔道进行手术操作方面走在外科的前列.经尿道电切、输尿管镜下取石等手术在取得令人满意的疗效同时又大大降低了手术所带来的创伤.随着内镜技术的进步,经自然孔道内镜手术作为一项新的微创手术技术应运而生.经自然孔道肾切除术及肾盂成形术等手术也逐渐从动物模型研究走向临床.本文将介绍经自然孔道内镜手术在泌尿外科中应用的现状及其研究进展.     

A Comprehensive Review of Single-Incision Laparoscopic Surgery (SILS) and Natural Orifice Transluminal Endoscopic Surgery (NOTES) Techniques for Cholecystectomy

Introduction  Surgery of the gallbladder has evolved tremendously over the last century. Laparoscopic cholecystectomy is the gold standard for gallbladder removal and the most common laparoscopic procedure worldwide. In recent times, innovative techniques of natural orifice transluminal endoscopic surgery (NOTES) and single-incision laparoscopic surgery (SILS) have been applied in gallbladder removal as a step towards even more less-invasive procedures. Discussion  While NOTES and SILS represent the advent of essentially scarless surgery, limited applications of these technologies in human subjects exists. In this article, we present a comprehensive review of the potential benefits, limitations and risks of these novel techniques. Conclusion  While much remains unknown and unanswered surrounding these procedures, it is clear that extensive research and development with regards to the ethics and the technical aspects of these procedures as well as randomized studies to compare them with traditional laparoscopy are essential.     

Current Evidence in Gastrointestinal Surgery: Natural Orifice Translumenal Endoscopic Surgery (NOTES)

Background

Natural orifice translumenal endoscopic surgery (NOTES) is a technique that uses transvisceral access to perform surgical procedures entirely through a natural orifice. Despite the increasing awareness of NOTES, there remain obstacles to its technical feasibility and widespread acceptance. Furthermore, with the paucity of high-level supporting evidence, NOTES currently remains an experimental technique.

Objective

This article reviews the goals, applications, technical and practical challenges, and future direction of NOTES in gastrointestinal surgery.     

NOTES: issues and technical details with introduction of NOTES into a small general surgery residency program.

BACKGROUND AND OBJECTIVES: Natural orifice translumenal endoscopic surgery (NOTES) is a development of recent origin. In 2004, Kalloo et al first described NOTES investigation in an animal model. Since then, several investigators have pursued NOTES study in animal survival and nonsurvival models. Our objectives for this project included studying NOTES intervention in a laboratory environment using large animal (swine) models and learning to do so in a safe, controlled manner. Ultimately, we intend to introduce NOTES methodology into our surgical residency training program. The expertise of an experienced laparoscopic surgeon, fellowship-trained laparoendoscopic surgeon, and veterinarian along with a senior surgical resident was utilized to bring the input of several disciplines to this study. The Institutional Animal Care and Use Committee (IACUC) of Northeastern Ohio Universities College of Medicine and Pharmacy (NEOUCOM/COP) approved this study. METHODS: A series of 5 laboratory sessions using mixed breed farm swine varying in weight from 37 kg to 43.1 kg was planned for the initial phase of NOTES introduction into our residency program. Animals were not kept alive in this investigation. All animals were anesthetized using a standard swine protocol and euthanized following guidelines issued by the American Veterinary Medical Association Panel on Euthanasia. Equipment included a Fujinon EVE endoscope 0.8 cm in diameter with a suction/irrigation channel and one working channel. Initially, a US Endoscopy gastric overtube, 19.5 mm OD and 50 cm in length, was used to facilitate passage of the endoscope. However, this device was found to have insufficient length. Subsequently, commercially available 5/8" diameter clear plastic tubing, 70 cm to 80 cm in length, was adapted for use as an overtube. Standard endoscopic instruments included Boston Scientific biopsy forceps, needle-knife, papillotome, endoscopic clip applier, and Valley Lab electrosurgical unit. A Karl Storz laparoscope and tower were used for laparoscopic observation of NOTES maneuvers. Necropsy was performed to determine specific details of surgical intervention. RESULTS: NOTES intervention is feasible in an animal model. Insight into the potential of NOTES was obtained in this investigation. CONCLUSIONS: NOTES investigation in a controlled, laboratory setting using an animal model proved to have value for our program. A steep learning curve was encountered despite the availability of an investigator familiar with elementary NOTES procedures. The authors strongly suggest investigators adopt the ASGE/SAGES working group recommendations for a multidisciplinary team possessing advanced therapeutic endoscopic and advanced laparoscopic skills to study NOTES before human investigation. Animal laboratory facilities to perform research and training should be available to the multidisciplinary team for exploration of NOTES techniques and procedures. Institutional Review Board (IRB) approval must be obtained before introduction of NOTES procedures in human patients.     

Natural Orifice Surgery: Transdouglas surgery--a new concept

BACKGROUND: During the 20th century, laparoscopic procedures replaced most traditional abdominal operations and achieved high-quality standards. It seemed that the optimal surgical method had been achieved; however, a new concept, which might possibly become even safer and simpler is now being developed, the concept of Natural Orifice Surgery (NOS). The existing natural openings of the body started to be used for introduction of surgical instruments for diagnostic purposes and surgical procedures, avoiding penetrating the abdominal wall. Parallel to the American Natural Orifice Surgery Consortium for Assessment and Research (NOSCAR) group, is the New European Surgical Academy (NESA) established in Berlin on June 23, 2006. It is the first European-based NOS working group with participation of scientists and surgeons from different disciplines and countries. After the published experimental achievements had been presented and discussed, the working group decided to concentrate mainly on the transvaginal/transdouglas access in women. DATABASE: A new surgical instrument, the Transdouglas Endoscopic Device (TED) has been designed. This is a flexible multichannel instrument enabling single-entry surgical, urological, and gynecological operations. TED respects the anatomy of the pelvis. To get to the upper abdomen, an S-shaped device was designed, bending first to the front, and then backwards. For the lower abdomen, the U-shaped mode of the instrument was designed. The wide diameter of the device (35 mm) and its multichannel design enables simultaneous use of different instruments, therefore avoiding hybrid procedures. Various surgical and gynecological procedures have been successfully simulated, and the manufacturing of the device is in progress. Preclinical studies will start soon. CONCLUSIONS: Transvaginal/transdouglas surgery is expected to be a valid alternative to traditional endoscopic procedures in women. It seems that NOS will create a spectrum of innovative and high-quality procedures performed by an interdisciplinary team and will improve patient safety.     

Systemic Inflammatory Response After Natural Orifice Translumenal Surgery: Transvaginal Cholecystectomy in a Porcine Model

Objective:

We analyzed circulating TNF-α and IL-6 to determine systemic inflammatory responses associated with transvaginal cholecystectomy in a porcine model.

Methods:

Six female pigs were used for a survival study after transvaginal cholecystectomy (NOTES group) using endoscopic submucosal dissection (ESD) instruments and a single-channel endoscope. Blood was drawn preoperatively and 24 hours and 48 hours postoperatively. Four pigs were used as controls. In addition, laparoscopic cholecystectomy was performed in 2 pigs for laparoscopic control.

Results:

In all 6 pigs in the NOTES group, no major intraoperative complications occurred. No significant differences were found between control, laparoscopic, and NOTES groups in terms of preoperative IL-6 level (P=0.897) and at 24 hours (P=0.790), and 48 hours postoperatively (P=0.945). Similarly, there was no significant difference in mean preoperative (P=0.349) and mean day 2 postoperative TNF-α levels (P=0.11). But a significant increase in day 1 postoperative TNF-α levels in the laparoscopic group compared with that in the control and NOTES groups was observed (P=0.049). One limitation of our study is that the sample size was relatively small.

Conclusion:

NOTES is safe in animal models in terms of anatomical and cellular level changes with minimal systemic inflammatory host responses elicited. Further study needs to be carried out in humans before NOTES can be recommended for routine use.     

Human NOTES Cholecystectomy: Transgastric Hybrid Technique

Background  Natural orifice translumenal endoscopic surgery (NOTES) is an emerging field in minimally invasive surgery that is driving the development of new technology and techniques. There are several proposed benefits to the NOTES approach, including potentially decreased abdominal pain, wound infections, and hernia formation Ko and Kalloo (Chin J Dig Dis 7:67–70, 2006); Wagh et al. (Clin Gastroenterol Hepatol 3(9):892–896, 2005); ASGE/SAGES Working Group on Natural Orifice Transluminal Endoscopic Surgery (Gastrointest Endosc 63(2):199–203, 2006); and Pearl and Ponsky (J GI Surg 12:1293–1300, 2008). Cholecystectomy has been one of the most commonly performed NOTES procedures to date, with the majority being performed through the transvaginal approach Marescaux et al. (Arch Surg 142:823–826, 2007); Zorron et al. (Surg Endosc 22:542–547, 2008); and Ramos et al. (Endoscopy 40:572–575, 2008). Transgastric approaches for cholecystectomy have been shown to be technically feasible in animal models and in several unpublished human patients Sumiyama et al. (Gastrointest Endosc 65(7):1028–1034, 2007). This video demonstrates the technique by which we perform transgastric NOTES hybrid cholecystectomy in human patients. Method  Patients with symptomatic gallstone disease are enrolled under an IRB approved protocol. A diagnostic EGD is performed to confirm normal anatomy. Peritoneal access is gained using a needle-knife cautery and balloon dilation under laparoscopic visualization. Dissection of the critical view of safety is performed endoscopically. The cystic duct and artery are clipped laparoscopically and the gallbladder is dissected off of the liver. The gastrotomy is closed intralumenally and over-sewed laparoscopically. The gallbladder is extracted out the mouth. Results  This technique was used to successfully perform four NOTES hybrid transgastric cholecystectomies without operative complications. Conclusions  NOTES hybrid transgastric cholecystectomy can be performed safely in human patients. This procedure is still technically challenging given the current instrumentation that is available. In order to perform a pure NOTES transgastric cholecystectomy, a safe blind access method, improved retraction, endoscopic hemostatic clips, and reliable closure methods need to be developed. Electronic supplementary material  The online version of this article (doi:) contains supplementary material, which is available to authorized users. Presented at SSAT/DDW, May 2008, San Diego, CA.     

Natural Orifice Transluminal Endoscopic Surgery

Natural orifice transluminal endoscopic surgery (NOTES) has generated healthy and vigorous debate about the introduction of an entirely novel method of surgical therapy. Although there are many reasons for scepticism, there is undoubted interest in this field from both the medical profession and general public. Those Associations currently involved in laparoscopic and endoscopic surgery wish to safeguard patients and the reputation of the profession by issuing clear guidance and support for those wishing to undertake NOTES. The purpose of this document is to review the current status of both NOTES and hybrid NOTES, while at the same time identifying obstacles in both clinical research and training. Furthermore, it aims to provide a consensus statement on behalf of the main UK specialty associations involved in this field of surgery. The primary aim of this consensus statement is to provide a framework within which to develop, safely and effectively, what must still be considered an experimental technique.     

Thyroidectomy Using Pure Natural Orifice Transluminal Endoscopic Surgery in a Porcine Model

Surgical procedures for thyroid disease that provide cosmetically acceptable results are in demand. Natural orifice transluminal endoscopic surgery (NOTES) is performed through natural orifices and thus avoids incision of the body wall. This study aimed to develop an incision‐free surgical procedure for thyroid lobectomy using pure NOTES with an oral approach. In six pig carcasses, an incision was made between the mandible and subcutaneous tissue under direct vision. After subcutaneous dissection and identification of the hyoid bone, the operative field was developed under endoscopic view. After the thyrohyoid membrane was identified, dissection was continued along the thyroid cartilage until the cricoid cartilage was identified and the thyroid isthmus was reached. An original retractor was inserted between dissected tissues to lift and fix the carcass. The thyroid gland was successfully removed through the incision. Similar macroscopic and histological findings were observed on the normal and treated sides, with no damage to the recurrent laryngeal nerves. The times required for securing the operative field and thyroidectomy improved with each operation. This study suggests the feasibility and safety of using pure NOTES for thyroidectomy through a subcutaneous route with an original retractor.     

经口腔前庭腔镜NOTES手术治疗甲状腺良性病变：附6例报告

目的:探讨经口腔前庭腔镜NOTES手术治疗甲状腺良性疾病的可行性。方法:2013年10月—2014年9月,对6例甲状腺良性病变患者采用经口腔前庭入路腔镜甲状腺NOTES手术。甲状腺结节位于右叶3例,左叶3例,均为单发结节;囊性结节1例,实性结节4例,混合性1例;结节直径1~4 cm。术前诊断甲状腺腺瘤1例,结节性甲状腺肿5例。结果:6例患者均成功实施经口腔前庭腔镜甲状腺NOTES手术,平均手术时间122(100~150)min;平均术中出血30(10~40)m L。其中甲状腺部分切除5例,单侧甲状腺大部分切除1例,无1例中转开放手术。病理诊断甲状腺腺瘤1例,结节性甲状腺肿5例。术后无神经或甲状旁腺损伤等严重并发症;平均住院时间8.2(8~10)d;随访3~13个月无局部复发。结论:经口腔前庭腔镜NOTES手术治疗甲状腺良性疾病是可行的,且切口隐蔽,美容效果满意。