Hybrid transvaginal cholecystectomy: a novel approach

Natural Orifice Transluminal Endoscopic Surgery (NOTES) allows cholecystectomy to be performed by means of a flexible scope introduced through the stomach, rectus, bladder, or vagina. However, available endoscopes have several limitations if used in the peritoneal cavity. The hybrid technique reported overcomes these limitations by using conventional 5-mm laparoscopic instruments through the umbilical scar and transabdominal sutures for retraction. After creating the pneumoperitoneum with a Veress needle, a 5-mm port is introduced into the umbilicus followed by a 5-mm, 30° scope. A culdotomy then is performed under direct and laparoscopic views. The flexible endoscope is inserted into the pelvis through the vagina and advanced to expose the gallbladder. Three or more transabdominal sutures are placed through the gallbladder wall for retraction. Cholecystectomy then is performed using conventional 5-mm laparoscopic instruments through the 5-mm umbilical port. Finally, stay sutures are removed and the specimen is retrieved through the vagina. Six patients successfully have undergone this new procedure. In our opinion this hybrid approach increases safety, overcomes the limitation of the current instrumentation, and maintains most of the advantages of Natural Orifice Transluminal Endoscopic Surgery.     

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.     

Total transvaginal endoscopic abdominal wall hernia repair: a NOTES survival study

Hypothesis Natural orifice transluminal endoscopic surgery (NOTES) has gained widespread interest as a potentially less invasive alternative to laparoscopic surgery or, else, an evolution as the next-generation surgery. The main objective of this study was to assess the safety of transluminal abdominal wall hernia repair for potential human application by specifically investigating the feasibility and challenges of using a transvaginal approach. Design NOTES ventral hernia repair via a transvaginal approach. Setting University Hospital (National University Health System, Singapore). Participants The study utilized five female pigs (30–40 kg) between 5 and 7 months of age, which underwent abdominal wall hernia repair using a transvaginal approach. Intervention The procedures were performed using a double-channel endoscope under general endotracheal anesthesia. A mesh was placed and fixed to the abdominal wall using standard laparoscopic and endoscopic equipment. The animals survived for 2 weeks and were then euthanized and a necropsy performed. Main outcome measures To assess the safety and feasibility of NOTES ventral hernia repair in a survival experimental model. Results All of the procedures could be safely performed using the standard equipment. At the necropsy, all meshes were well in place and mild adhesions were recorded in one animal with a small abscess in the subcutaneous area. Conclusion This novel approach seems technically challenging but feasible using equipment and accessories currently available for conventional laparoscopic and interventional endoscopy with low intra-abdominal contamination and sepsis. New procedure-specific instruments and equipment need to be developed to allow the surgeon safer access and more degrees of instrument freedom.     

Completely transvaginal NOTES cholecystectomy using magnetically anchored instruments

Introduction Natural orifice translumenal endoscopic surgery (NOTES) is an evolving field and suitable instruments are lacking. The purpose of this study was to perform transvaginal cholecystectomies using instruments incorporated into a magnetic anchoring and guidance system (MAGS). Methods Non-survival procedures were conducted in pigs (n = 4). Through a vaginotomy created under direct vision, a rigid access port was inserted into the peritoneal cavity and used to maintain a CO₂ pneumoperitoneum. MAGS instruments were deployed through the port and held in place on the peritoneal surface using magnetic coupling via an external handheld magnet which was optionally exchanged for an 18ga percutaneous threaded needle anchor; instruments included a tissue retractor (a clip-fixated magnet or flexible graspers) and a cautery dissector. A gastroscope was used for visualization. Results The first two procedures ended prematurely due to instrumentation shortcomings and inadvertent magnetic coupling between instruments; one case required a laparoscopic rescue. Three new forms of instrumentation were developed: (1) a longer access port (50 cm) which provided easier deployment of instruments and suitable reach, (2) a more robust cauterizer with a longer, more rigid, pneumatically deployed tip with better reach and sufficient torque to allow blunt dissection, and (3) a more versatile tissue retractor with bidirectional dual flexible graspers which provided excellent cephalad fundus retraction and inferiolateral infundibulum retraction. With these modifications, 100% of the cholecystectomy was completed in the third and fourth animals using only a NOTES/MAGS approach. Retrieval of the tissue retractor resulted in a rectal injury in the third animal but further procedural modifications resulted in a successful procedure in the fourth animal with no complications. Conclusions While still under development with more refinements needed, completely transvaginal cholecystectomy using MAGS instruments is feasible. By offering triangulation and rigidity, MAGS may facilitate a NOTES approach while alleviating shortcomings of a flexible platform.     

Evaluation for transvaginal and transgastric NOTES cholecystectomy in human and animal natural orifice translumenal endoscopic surgery

Background/purpose  Natural orifice translumenal endoscopic surgery (NOTES) is a novel concept using an endoscope via a translumenal access for abdominal surgery. This study was designed to evaluate the feasibility and technical aspects of NOTES cholecystectomy from our experience on humans and animals. Methods  NOTES cholecystectomies were performed in 12 animal experiments, including 8 pigs (6 by transgastric and 2 by transvaginal accesses) and 4 dogs (4 transvaginal accesses), and a human female cadaver. Results  The entire gallbladder could be removed under direct vision in all experiments. The average time was 60 min by transgastric and 40 min by transvaginal in animals. It was 87 min for human transvaginal cholecystectomy. In all animal and human procedures, there was no major complication concerning the operation. Discussion  The transvaginal route may be the easiest route for abdominal NOTES. Percutaneous endoscopic gastrostomy (PEG) allowed the safe performance of a controlled gastric perforation and shortened the time. The hybrid method allowed performance of a safe procedure and shortened the time. Conclusions  Transvaginal and transgastric NOTES cholecystectomy is technically feasible and safe in both humans and animals. New instrumentation needs to be developed to perform a pure NOTES cholecystectomy without transabdominal assistance.     

Pure NOTES transvaginal appendectomy with gasless laparoscopy

Background

The vagina is the most widely used approach to natural orifice transluminal endoscopic surgery. However, a gas leak can significantly affect transvaginal operations during pneumoperitoneum laparoscopy. We tried to establish the proper technique for transvaginal appendectomy under gasless laparoscopy.

Materials and methods

Five patients with chronic appendicitis were selected to receive gasless laparoscopic transvaginal appendectomy with concurrent vaginal hysterectomy. An abdominal wall-lifting device was applied after removal of the uterus, and the appendix was removed transvaginally. Clinical data such as operative duration, bleeding volume, morbidity, and hospital stay duration were analyzed.

Results

All procedures were performed successfully, without intraoperative or major postoperative complications. The appendectomy portion of the procedure took approximately 20–30 minutes, with minimal blood loss. All patients were discharged, scar-free, 3 d after surgery.

Conclusions

Transvaginal appendectomy with gasless laparoscopy after vaginal hysterectomy appears to be a feasible and safe modification of established techniques, with acceptable outcomes.     

经阴道内镜胆囊切除术的实验研究

目的:探讨在动物模型上完成经阴道联合经脐入路内镜胆囊切除术的安全性及可行性。方法:用6只3~5个月、体重28~30kg的三元杂交雌猪行经阴道内镜胆囊切除术。实验猪取仰卧位,经脐部切口穿刺两个自制直径5mm Trocar,插入腹腔镜探查腹腔,并在腔镜直视下从阴道后穹窿穿刺自制5mm Trocar及操作器械。在腔镜下解剖胆囊三角,电刀游离胆囊,分离出胆囊管,用可吸收线圈套器圈扎胆囊管后用超声刀离断胆囊管,切除胆囊标本后由阴道取出。阴道切口不予缝合。实验动物术后24h开始进食,饲养1周后处死解剖。结果:6例手术均成功完成,手术时间24~42m in,平均(31.7±10.6)m in。术中无明显出血及周围脏器损伤。术后饲养1周,均生长良好,未见明显并发症。尸检见手术创面及阴道切口愈合良好,腹壁未见疤痕。结论:经阴道联合经脐胆囊切除术安全可行,此手术径路具有手术效率高、美容效果好等优点。     

Adrenalectomy using natural orifice translumenal endoscopic surgery (NOTES): A transvaginal retroperitoneal approach

Background  Endoscopic adrenalectomy currently is performed using either a retroperitoneal or transperitoneal approach. The retroperitoneal approach is ideal for patients with small lesions who have undergone previous intraabdominal surgery. This study aimed to explore transvaginal retroperitoneal right and left adrenalectomies in porcine and cadaver models. Methods  Right and left adrenalectomies were performed for two female pigs. With the pig supine under general anaesthesia, the retroperitoneal space was entered with a double-channel endoscope (Storz) through a posterior colpotomy. A retroperitoneal tunnel was fashioned using blunt dissection with the assistance of low carbon dioxide insufflation up to the inferior pole of the kidney. Dissection of the upper renal pole allowed access to the adrenal gland. Using blunt dissection, a plane was created between the aorta on the left and the adrenal gland and inferior vena cava on the right. The left main middle vascular pedicle was identified and taken between clips, whereas an endoloop was used on the right side. The specimen was retrieved intact with a polypectomy snare. The same access then was reproduced with two female cadavers. Results  Transvaginal retroperitoneal adrenalectomies were successfully accomplished with a transvaginal approach using natural orifice translumenal endoscopic surgery (NOTES). The operative time was 70 min, and there was no injury to the retroperitoneal structures. The access was effectively reproduced in the cadaver model, with prompt identification of the retroperitoneal anatomic landmarks. Conclusion  Transvaginal retroperitoneal NOTES adrenalectomy is feasible in the porcine model. It reaches the adrenal proper anatomic plane with no need for dissection or retraction of the surrounding organs. This technique might be especially valuable for patients with multiple previous abdominal operations and obese patients in that allows direct access to the adrenal gland and minimizes the cardiovascular and pulmonary risk related to carbon dioxide pneumoperitoneum. Although the operation was successfully validated with cadavers, further experiments and better tools are needed before NOTES transvaginal retroperitoneal access is considered for humans. Electronic supplementary material  The online version of this article (doi:) contains supplementary material, which is available to authorized users.     

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.     

NOTES Hybrid Transvaginal Radical Nephrectomy for Tumor: Stepwise Progression Toward a First Successful Clinical Case

Background

Natural orifice translumenal endoscopic surgery (NOTES) has been used to perform nephrectomy in the laboratory; however, clinical reports to date have used multiple abdominal trocars to assist the transvaginal procedure.

Objective

To present our stepwise technique development and the first successful clinical case of NOTES transvaginal radical nephrectomy for tumor with umbilical assistance without extraumbilical skin incisions.

Design, setting, and participants

The four transvaginal NOTES procedures were performed at two institutions after obtaining institutional review board approval. Various operative steps were developed experimentally in three clinical cases, and on March 7, 2009, we performed the first successful case of NOTES hybrid transvaginal radical nephrectomy without any extraumbilical skin incisions. Using one multichannel access port in the vagina and one in the umbilicus, laparoscopic visualization, intraoperative tissue dissection, and hilar control were performed transvaginally and transumbilically. The intact specimen was extracted transvaginally.

Measurements

All perioperative data were accrued prospectively. A stepwise progression to the successful completion of the fourth case is systematically presented.

Results and limitations

Intraoperatively, at incrementally more advanced stages of the procedure, the first three NOTES clinical cases were electively converted to standard laparoscopy because of rectal injury during vaginal entry, of failure to progress, and of gradual bleeding during upper-pole dissection after transvaginal hilar control, respectively. The fourth case was successfully completed via transvaginal and umbilical access without conversion to standard laparoscopy. Operative time was 3.7 h, estimated blood loss was 150 cm³, and hospital stay was 1 d. Final pathology confirmed a 220-g, pT1b, 7-cm, grade 2, clear-cell renal cell carcinoma with negative margins. The patient was readmitted for an intraabdominal collection that responded to drainage and antibiotics.

Conclusions

We report our stepwise progression and the initial successful clinical case of NOTES hybrid transvaginal radical nephrectomy for tumor, assisted with only one umbilical trocar. Although transvaginal nephrectomy is feasible in the highly selected patient with favorable intraoperative circumstances, considerable refinements in technique and technology are necessary if this approach is to advance beyond mere anecdote.     

Cholecystectomy by a combined transgastric and transparietal approach using two flexible endoscopes

Objective  This experimental study was designed to assess the technical feasibility and benefits of our novel approach for transgastric NOTES (natural orifice translumenal endoscopic surgery) cholecystectomy. Methods  Four pigs were subjected to NOTES cholecystectomy by the combined transgastric and transparietal approach using two flexible endoscopes. Under the guidance of a transparietal endoscope inserted through a trocar placed in the right upper abdomen, a gastrotomy was constructed, and a peroral endoscope was advanced into the peritoneal cavity through the gastrotomy and moved on retroflexion toward the gallbladder. Gallbladder excision with ligation of the cystic artery and duct using endoclips was performed using the peroral endoscope. After gastrotomy closure with endoclips inside the stomach, intraperitoneal lavage were carried out using the transparietal endoscope. Results  A complete gallbladder excision was carried out without major adverse events in all cases. The gastrotomies were successfully closed using endoclips (n = 3) or by the omentum-plug method (n = 1). Conclusion  This approach is technically feasible and makes transgastric NOTES cholecystectomy easier and safer.     

Natural orifice transluminal endoscopic surgery: The transvaginal route moving forward from cholecystectomy

The advent of minimally invasive surgery and the advances in endoluminal flexible endoscopy have converged to generate a new concept in digestive surgery, whose acronym natural orifice transluminal endoscopic surgery (NOTES), has become a familiar term in the surgical community. NOTES has been performed through the mouth, the bladder, the rectum and the vagina. Of these four approaches, the vagina has gained most popularity for several reasons. It is not only readily accessible and easy to decontaminate but it also provides safe entry and simple closure. The transvaginal approach has been described in the experimental and the clinical setting as an option for cholecystectomy, nephrectomy, splenectomy, segmental gastrectomy, retroperitoneal exploration and bariatric surgery. However, larger series are needed to delineate the exact risks of this approach, and to transcend cultural barriers that impede its wider introduction. Prospective randomized trials will shed light on the definitive role of the vaginal approach in minimal invasive surgery of the future.     

Natural orifice translumenal endoscopic surgery (NOTES) for innovation in hepatobiliary and pancreatic surgery: preface

Introduction  Natural orifice translumenal endoscopic surgery (NOTES) has captured the interest of interventional endoscopists and may represent the next stage of evolution of minimally invasive surgery. It provides the potential for performance of incisionless operations. It is gaining momentum both in the animal laboratory and in human case reports. Developments in the field of NOTES have led to the formation of the Natural Orifice Surgery Consortium for Assessment and Research (NOSCAR) in 2006. Materials and methods  In this special issue, the current trends in NOTES in the field of hepatobiliary and pancreatic surgery are featured, including NOTES cholecystectomy, hepatectomy splenectomy, pancreatic necrosectomy, and the future of NOTES. In this issue, we discuss the potential benefits of these procedures in hepatobiliary and pancreatic surgery. Conclusion  We have just started the evaluation process for this new technology. The concept of NOTES is becoming established and is enormously advantageous for the patient. Both the surgeon and gastroenterologist should contribute to developing NOTES in making use of their specialties.     

经脐单孔腹腔镜胆囊切除术（附12例报告及文献复习）

目的探讨经脐单孔腹腔镜胆囊切除术的临床应用前景。方法报告2008年5~8月首都医科大学附属北京友谊医院普外科完成12例经脐单孔腹腔镜胆囊切除术的手术方法及临床效果。结果12例手术均获成功,无并发症发生,术后恢复好,病人满意。结论经脐单孔腹腔镜胆囊切除术操作难度较大,但具有无瘢痕等优点,有技术条件的医院可以在慎重选择病例的基础上开展。     

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.     

经阴道自然腔道内镜卵巢囊肿剥除术十例临床分析

目的评估经阴道自然腔道内镜(natural orifice transluminal endoscopic surgery,NOTES)卵巢囊肿剥除术的可行性、安全性及术后恢复情况。 方法回顾分析2017年9－12月在上海市第一妇婴保健院妇科行NOTES卵巢囊肿剥除术患者10例,所有患者取阴道后穹窿入路2.5 cm切口,置入硅胶密封圈后,装上Port,建立气腹后用传统腹腔镜行患侧卵巢囊肿剥除术。统计卵巢囊肿大小、手术时间、术前与术后血色素差值、术中出血量、术后24 h视觉模拟疼痛评分(visual analog scale,VAS)及术后恢复排气时间。 结果其中1例患者因双侧卵巢成熟性囊性畸胎瘤合并多囊卵巢综合征,由于卵巢门出血略活跃、缝合困难影响手术进展,中转为传统腹腔镜手术之外,其他患者均经阴道腹腔镜完成,手术均无并发症、无输血。9例患者的平均手术时间78.3 min,术前与术后血色素的平均差值18.3 g/L,平均术中出血量23.3 ml,术后24 h VAS平均0.55分,术后平均恢复排气时间17.5 h,平均住院时间4.7 d。 结论NOTES卵巢囊肿剥除术后患者的切口疼痛感较轻,具有术后恢复快、腹部无瘢痕、美观的优势,合适的病例选择加上灵活的手术技巧,NOTES卵巢良性囊肿剥除是安全可行的。