Bryan J. Sandler

Natural orifice surgery: initial clinical experience

BackgroundNatural orifice translumenal endoscopic surgery (NOTES) has moved quickly from preclinical investigation to clinical implementation. However, several major technical problems limit clinical NOTES including safe access, retraction and dissection of the gallbladder, and clipping of key structures. This study aimed to identify challenges and develop solutions for NOTES during the initial clinical experience.MethodsUnder an Institutional Review Board (IRB)-approved protocol, patients consented to a natural orifice operation for removal of either the gallbladder or the appendix via either the vagina or the stomach using a single umbilical trocar for safety and assistance.ResultsNine transvaginal cholecystectomies, one transgastric appendectomy, and one transvaginal appendectomy have been completed to date. All but one patient were discharged on postoperative day 1 as per protocol. No complications occurred.ConclusionThe limited initial evidence from this study demonstrates that NOTES is feasible and safe. The addition of an umbilical trocar is a bridge allowing safe performance of NOTES procedures until better instruments become available. The addition of a flexible long grasper through the vagina and a flexible operating platform through the stomach has enabled the performance of NOTES in a safe and easily reproducible manner. The use of a uterine manipulator has facilitated visualization of the cul de sac in women with a uterus to allow for safe transvaginal access.

Outcomes of Robotic-Assisted Transhiatal Esophagectomy for Esophageal Cancer After Neoadjuvant Chemoradiation

BACKGROUND We previously reported our experience performing robotic-assisted transhiatal esophagectomy (RATE) in patients with early-stage esophageal cancer who had had no preoperative treatment. The purpose of this report was to determine if RATE could be performed safely with good outcomes for esophageal cancer in a more recent series of patients, the majority of whom were treated with neoadjuvant chemoradiation. SUBJECTS AND METHODS This was a retrospective review of patients with adenocarcinoma of the distal esophagus or gastroesophageal junction who underwent RATE between November 2006 and November 2012 at a single tertiary-care hospital. Main outcome measures included operative and oncologic parameters, morbidity, and mortality. RESULTS In total, 23 patients underwent RATE, consisting of 20 men and 3 women with a median age of 64 years (range, 40-81 years). The majority of patients (19/23 [83%]) underwent neoadjuvant chemoradiation, although 1 patient had preoperative chemotherapy only, and 3 patients went straight to surgery. Median operative time was 231 minutes (range, 179-319 minutes), and median estimated blood loss was 100 mL (range, 25-400 mL). There were no conversions to open surgery. Complications included seven strictures, two anastomotic leaks, and two pericardial/pleural effusions requiring drainage. One patient required pyloroplasty 3 months after esophagectomy. One patient died from pulmonary failure 21 days after surgery (30-day mortality rate of 4%). The median length of stay was 9 days (range, 7-37 days). Seven of the 19 patients who underwent preoperative chemoradiation had a complete response on final pathology. The mean lymph node yield was 15 (range, 5-29), and surgical margins were negative for cancer in 21 cases. CONCLUSIONS RATE can be performed safely with good oncologic outcomes following neoadjuvant chemoradiation in patients with esophageal cancer. This technique has become our choice of operation for most patients with esophageal cancer.

SAGES TAVAC safety and effectiveness analysis: da Vinci ® Surgical System (Intuitive Surgical, Sunnyvale, CA).

AbstractBackgroundThe da Vinci® Surgical System (Intuitive Surgical, Sunnyvale, CA, USA) is a computer-assisted (robotic) surgical system designed to enable and enhance minimally invasive surgery. The Food and Drug Administration (FDA) has cleared computer-assisted surgical systems for use by trained physicians in an operating room environment for laparoscopic surgical procedures in general, cardiac, colorectal, gynecologic, head and neck, thoracic and urologic surgical procedures. There are substantial numbers of peer-reviewed papers regarding the da Vinci® Surgical System, and a thoughtful assessment of evidence framed by clinical opinion is warranted.Methods The SAGES da Vinci® TAVAC sub-committee performed a literature review of the da Vinci® Surgical System regarding gastrointestinal surgery. Conclusions by the sub-committee were vetted by the SAGES TAVAC Committee and SAGES Executive Board. Following revisions, the document was evaluated by the TAVAC Committee and Executive Board again for final approval.ResultsSeveral conclusions were drawn based on expert opinion organized by safety, efficacy, and cost for robotic foregut, bariatric, hepatobiliary/pancreatic, colorectal surgery, and single-incision cholecystectomy.ConclusionsGastrointestinal surgery with the da Vinci® Surgical System is safe and comparable, but not superior to standard laparoscopic approaches. Although clinically acceptable, its use may be costly for select gastrointestinal procedures. Current data are limited to the da Vinci® Surgical System; further analyses are needed.

Antireflux Action of Nissen Fundoplication and Stretch-Sensitive Mechanism of Lower Esophageal Sphincter Relaxation

BACKGROUND & AIMS Surgical fundoplication is an effective treatment for gastroesophageal reflux disease. One of the proposed mechanisms for its antireflux action is that it reduces lower esophageal sphincter (LES) relaxation. We investigated whether fundoplication works through a stretch-sensitive mechanism of LES relaxation. METHODS Studies were performed in rats. Intravenous and arterial lines were placed and tracheal intubation was performed. A midline laprotomy was performed to place sutures through the esophagus to exert axial stretch on the LES, and the vagus nerve was isolated in the neck for electrical stimulation. The LES pressure was monitored with a 2F solid-state pressure transducer placed through a gastrostomy. Cranial displacement of the LES was recorded using piezoelectric crystals. Data were recorded before and after 360-degree Nissen fundoplication. RESULTS Axial stretch and vagus nerve stimulation induced cranial displacement of the LES as well as LES relaxation in a dose-dependent manner. LES relaxation and axial stretch were each significantly reduced after fundoplication (P < .01). Nitric-oxide-induced LES relaxation was not affected by fundoplication. Removal of fundoplication restored axial stretch- and vagus nerve-stimulated LES relaxation as well as LES cranial displacement. CONCLUSIONS Fundoplication reduces LES relaxation by interfering with axial stretch on the LES. Based on this mechanism of the antireflux actions of fundoplication, it might be possible to design new surgical strategies to treat reflux disease and reduce complications of fundoplication surgery.

Quality and safety in obesity surgery-15 years of Roux-en-Y gastric bypass outcomes from a longitudinal database.

BACKGROUND Most population-based studies lack long-term data, making the reporting of true mortality and outcome rates difficult. An accurate estimate of these rates in a high-risk population is critical for obtaining informed consent, especially for an elective procedure such as Roux-en-Y gastric bypass (RYGB). OBJECTIVES To examine the longitudinal outcomes of RYGB. SETTING The California Office of Statewide Health Planning and Development (OSHPD) longitudinal database. METHODS The OSHPD longitudinal database was queried for patients who underwent RYGB between 1995 and 2009. The primary outcome was mortality rates at 1, 5, and 10 years. Secondary outcomes were marginal ulcer and reoperation. The Cox hazard proportional analysis was used to determine adjusted survival and long-term outcomes for laparoscopic RYGB compared with open RYGB. RESULTS The study included 129,432 RYGB patients. Rates of laparoscopy increased from 3% to 35% from 1995 to 2004 and then steeply increased to 80% in 2005 and to 93% in 2009. Overall mortality rate at 1, 5, and 10 years was 2.2%, 4.4%, and 8.1%, respectively; the rates of marginal ulcer were .3%, .7%, and 1%, respectively; and the reoperation rates were .3%, .8%, and 1.2%, respectively. Predictors of poor outcomes were male gender, age, smoking, alcohol, Medicare, Medi-Cal insurance, and Asian or Native American race. The laparoscopic approach was protective against death (hazard ratio [HR] 95% confidence interval [95%CI]: .63[.58-.69]) and long-term complications (HR .78[.72-.85]). CONCLUSIONS This longitudinal population study showed high rates of mortality following RYGB, with improved long-term outcomes when the laparoscopic approach was used.

Magnetic lower esophageal sphincter augmentation device removal

Implantation of a magnetic lower esophageal sphincter augmentation device is now an alternative to fundoplication in the surgical management of gastroesophageal reflux disease (GERD). Although successful management of GERD has been reported following placement of the device, there are instances when device removal is needed. The details of the technique for laparoscopic magnetic lower esophageal sphincter device removal are presented to assist surgeons should device removal become necessary.

Intraoperative Endoscopic Botox Injection During Total Esophagectomy Prevents the Need for Pyloromyotomy or Dilatation

BACKGROUND Esophagectomy may lead to impairment in gastric emptying unless pyloric drainage is performed. Pyloric drainage may be technically challenging during minimally invasive esophagectomy and can add morbidity. We sought to determine the effectiveness of intraoperative endoscopic injection of botulinum toxin into the pylorus during robotic-assisted esophagectomy as an alternative to surgical pyloric drainage. MATERIALS AND METHODS We performed a retrospective analysis of patients with adenocarcinoma and squamous cell carcinoma of the distal esophagus or gastroesophageal junction who underwent robotic-assisted transhiatal esophagectomy (RATE) without any surgical pyloric drainage. Patients with and without intraoperative endoscopic injection of 200 units of botulinum toxin in 10 cc of saline (BOTOX group) were compared to those that did not receive any pyloric drainage (noBOTOX group). Main outcome measure was the incidence of postoperative pyloric stenosis; secondary outcomes included operative and oncologic parameters, length of stay (LOS), morbidity, and mortality. RESULTS From November 2006 to August 2014, 41 patients (6 females) with a mean age of 65 years underwent RATE without surgical drainage of the pylorus. There were 14 patients in the BOTOX group and 27 patients in the noBOTOX group. Mean operative time was not different between the comparison groups. There was one conversion to open surgery in the BOTOX group. No pyloric dysfunction occurred in the BOTOX group postoperatively, and eight stenoses in the noBOTOX group (30%) required endoscopic therapy (P < .05). There were no differences in incidence of anastomotic strictures or anastomotic leaks. One patient in group noBOTOX required pyloroplasty 3 months after esophagectomy. There was one death in the noBOTOX group postoperatively (30-day mortality 2.4%). Mean LOS was 9.6 days, and BOTOX patients were discharged earlier (7.4 versus 10.7, P < .05). CONCLUSION Intraoperative endoscopic injection of botulinum toxin into the pylorus during RATE is feasible, safe, and effective and can prevent the need for pyloromyotomy.

736 Initial Experience With an Innovative Endoscopic Clipping System

There are few options for the treatment of fistulas, leaks, and perforations endoscopically. Here we describe our experience with an endoscopic clipping system. A retrospective review of all cases using the Over-The-Scope-Clip system (Ovesco Endoscopy AG, Tuebingen, Germany) was performed. The system was utilized in ten patients with gastrointestinal surgical complications. Four patients had gastric leaks following sleeve gastrectomy, one had a post-operative colonic leak, two had gastro-gastric fistulas following gastric bypass, and three had esophageal perforations. Two leak patients had complete resolution, one had a contained leak following clip placement that was clinically insignificant, and the fourth patient had a persistent leak despite two clipping procedures. Two patients had gastro-gastric fistulas following roux-en-y gastric bypass surgery and, while they both had initial success, the fistulas recurred. One patient presented with anastomotic leak following colon resection but the system was unable to reach the treatment site. Three patients were successfully treated for esophageal perforation. There were no complications. This over-the-scope endoscopic clip system is simple to use, safe, and successful in approximating tissue to treat traditionally difficult surgical complications. Further experience and longer follow-up are needed to assess its indications as related to defect size and location.

Feasibility and technique for transvaginal natural orifice transluminal endoscopic surgery liver resection: A porcine model

Introduction: Natural orifice transluminal endoscopic surgery (NOTES) is a challenging minimally invasive procedure. Although laparoscopic techniques for liver resection are gaining acceptance worldwide, few studies have investigated NOTES liver resection. We used a porcine model to assess the feasibility and safety of transvaginal NOTES liver resection (TV NOTES LR). Materials and Methods: Nine female pigs underwent TV NOTES LR. A nonsurvival acute porcine model with general anesthesia was used in all cases. Using hybrid NOTES technique, we placed only 1 umbilical 12-mm umbilical trocar in the abdominal wall, which was used to create pneumoperitoneum. A laparoscope was then advanced to obtain intra-abdominal visualization. A 15-mm vaginal trocar was inserted under direct laparoscopic vision, and a flexible endoscope was introduced through the vaginal trocar. A long, flexible grasper and endocavity retractor were used to stably retract the liver. The liver edge was partially transected using energy devices inserted through the umbilical trocar. To transect the left lateral lobe, a flexible linear stapler was inserted alongside the vaginal trocar. A specimen extraction bag was deployed and extracted transvaginally. Blood loss, bile leakage, operative time, and specimen size were evaluated. Necropsy studies were performed after the procedures. Results: Eighteen transvaginal NOTES partial liver resections and 4 transvaginal NOTES left lateral lobectomies were successfully performed on 9 pigs. Mean operative time was 165.8 minutes, and mean estimated blood loss was 76.6 mL. All TV NOTES LRs were performed without complications or deaths. Necropsy showed no bile leakage from remnant liver. Conclusions: Our porcine model suggests that TV NOTES LR is technically feasible and safe and has the potential for clinical use as a minimally invasive alternative to conventional laparoscopic liver resection.

Screening pre-bariatric surgery patients for esophageal disease with esophageal capsule endoscopy

AIM To determine if esophageal capsule endoscopy (ECE) is an adequate diagnostic alternative to esophagogastroduodenoscopy (EGD) in pre-bariatric surgery patients. METHODS We conducted a prospective pilot study to assess the diagnostic accuracy of ECE (PillCam ESO2, Given Imaging) vs conventional EGD in pre-bariatric surgery patients. Patients who were scheduled for bariatric surgery and referred for pre-operative EGD were prospectively enrolled. All patients underwent ECE followed by standard EGD. Two experienced gastroenterologists blinded to the patients history and the findings of the EGD reviewed the ECE and documented their findings. The gold standard was the findings on EGD. RESULTS Ten patients with an average body mass index of 50 kg/m(2) were enrolled and completed the study. ECE identified 11 of 14 (79%) positive esophageal/gastroesophageal junction (GEJ) findings and 14 of 17 (82%) combined esophageal and gastric findings identified on EGD. Fishers exact test was used to compare the findings and no significant difference was found between ECE and EGD (P = 0.64 for esophageal/GEJ and P = 0.66 for combined esophageal and gastric findings respectively). Of the positive esophageal/GEJ findings, ECE failed to identify the following: hiatal hernia in two patients, mild esophagitis in two patients, and mild Schatzki ring in two patients. ECE was able to identify the entire esophagus in 100%, gastric cardia in 0%, gastric body in 100%, gastric antrum in 70%, pylorus in 60%, and duodenum in 0%. CONCLUSION There were no significant differences in the likelihood of identifying a positive finding using ECE compared with EGD in preoperative evaluation of bariatric patients.