Garth R. Jacobsen

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.

The role of robotic surgery in morbid obesity.

The purpose of this review was to form a collaborative opinion regarding the utility of robotic technology, specifically the da Vinci robot (Intuitive Surgical, Inc., Sunnyvale, CA), for bariatric surgery. Eleven surgeons are currently using the da Vinci system to perform laparoscopic bariatric surgery. The surgeons were queried about the type of robotic bariatric surgery and number of cases performed, complications, and any available outcomes data. They were also asked to give their opinion of the current state of robotic bariatric surgery. Ten of the 11 surgeons responded. Six surgeons are currently using the system for Roux-en-Y gastric bypass, three for laparoscopic adjustable gastric banding, and three for biliary pancreatic diversion. Robotic technology is successfully being applied to bariatric surgery in a few advanced minimally invasive surgery centers throughout the United States.

Incisionless revision of post-Roux-en-Y bypass stomal and pouch dilation: multicenter registry results.

BACKGROUND Surgical revision for weight regain after Roux-en-Y gastric bypass (RYGB) has been tempered by the high complication rates associated with standard approaches. Endoluminal revision of stoma and pouch dilation should intuitively confer a better risk profile. However, questions of clinical safety, durability, and weight loss need to be answered. We report our multicenter intraoperative experience and postoperative follow-up to date using the Incisionless Operating Platform for this patient subset. METHODS The patients who had regained significant weight >or=2 years after RYGB after losing >or=50% of excess body weight after RYGB were endoscopically screened for stomal and/or pouch dilation. Qualified patients underwent incisionless revision using the Incisionless Operating Platform to reduce the stoma and pouch size by placing anchors to create tissue plications. Data on the safety, intraoperative performance, postoperative weight loss, and anchor durability were recorded to date as a part of 2 years of postoperative follow-up. RESULTS A total of 116 consecutive patients were prospectively studied. Anchors were successfully placed in 112 (97%) of 116 patients, with an average intraoperative stoma diameter and pouch length reduction of 50% and 44%, respectively. The operating room time averaged 87 minutes. No significant complications occurred. At 6 months after the procedure (n = 96), an average of 32% of weight regain that had occurred after RYGB had been lost. The percentage of excess weight loss averaged 18%. The 12-month esophagogastroduodenoscopy results confirmed the presence of the anchors and durable tissue folds. CONCLUSIONS Incisionless revision of stoma and pouch dilation using the Incisionless Operating Platform can be performed safely. The data to date have demonstrated mild-to-moderate weight loss, and the early 12-month endoscopic images have confirmed anchor durability. Patients were actively followed up to document the long-term durability of this intervention in the entire patient subset.

Robotic-assisted thoracoscopic resection of esophageal leiomyoma

Esophageal leiomyoma represents 70–80% of all benign esophageal tumors but only approximately 0.5% of all esophageal neoplasms; optimal surgical treatment consists of local resection. We present the first reported robotic-assisted thoracoscopic resection of two patients with esophageal leiomyoma using the daVinci Surgical System. Operative technique and technical considerations are presented.

Long-term Outcomes of Patients Receiving a Magnetic Sphincter Augmentation Device for Gastroesophageal Reflux

BACKGROUND & AIMS Based on results from year 2 of a 5-year trial, in 2012 the US Food and Drug Administration approved the use of a magnetic device to augment lower esophageal sphincter function in patients with gastroesophageal reflux disease (GERD). We report the final results of 5 years of follow-up evaluation of patients who received this device. METHODS We performed a prospective study of the safety and efficacy of a magnetic device in 100 adults with GERD for 6 months or more, who were partially responsive to daily proton pump inhibitors (PPIs) and had evidence of pathologic esophageal acid exposure, at 14 centers in the United States and The Netherlands. The magnetic device was placed using standard laparoscopic tools and techniques. Eighty-five subjects were followed up for 5 years to evaluate quality of life, reflux control, use of PPIs, and side effects. The GERD-health-related quality of life (GERD-HRQL) questionnaire was administered at baseline to patients on and off PPIs, and after placement of the device; patients served as their own controls. A partial response to PPIs was defined as a GERD-HRQL score of 10 or less on PPIs and a score of 15 or higher off PPIs, or a 6-point or more improvement when scores on vs off PPI were compared. RESULTS Over the follow-up period, no device erosions, migrations, or malfunctions occurred. At baseline, the median GERD-HRQL scores were 27 in patients not taking PPIs and 11 in patients on PPIs; 5 years after device placement this score decreased to 4. All patients used PPIs at baseline; this value decreased to 15.3% at 5 years. Moderate or severe regurgitation occurred in 57% of subjects at baseline, but only 1.2% at 5 years. All patients reported the ability to belch and vomit if needed. Bothersome dysphagia was present in 5% at baseline and in 6% at 5 years. Bothersome gas-bloat was present in 52% at baseline and decreased to 8.3% at 5 years. CONCLUSIONS Augmentation of the lower esophageal sphincter with a magnetic device provides significant and sustained control of reflux, with minimal side effects or complications. No new safety risks emerged over a 5-year follow-up period. These findings validate the long-term safety and efficacy of the magnetic sphincter augmentation device for patients with GERD. ClinicalTrials.gov no: NCT00776997.

Factors Associated With General Surgery Residents’ Desire to Leave Residency Programs: A Multi-institutional Study

IMPORTANCE General surgical residency continues to experience attrition. To date, work hour amendments have not changed the annual rate of attrition. OBJECTIVE To determine how often categorical general surgery residents seriously consider leaving residency. DESIGN, SETTING, AND PARTICIPANTS At 13 residency programs, an anonymous survey of 371 categorical general surgery residents and 10-year attrition rates for each program. Responses from those who seriously considered leaving surgical residency were compared with those who did not. MAIN OUTCOMES AND MEASURES Factors associated with the desire to leave residency. RESULTS The survey response rate was 77.6%. Overall, 58.0% seriously considered leaving training. The most frequent reasons for wanting to leave were sleep deprivation on a specific rotation (50.0%), an undesirable future lifestyle (47.0%), and excessive work hours on a specific rotation (41.4%). Factors most often cited that kept residents from leaving were support from family or significant others (65.0%), support from other residents (63.5%), and perception of being better rested (58.9%). On univariate analysis, older age, female sex, postgraduate year, training in a university program, the presence of a faculty mentor, and lack of Alpha Omega Alpha status were associated with serious thoughts of leaving surgical residency. On multivariate analysis, only female sex was significantly associated with serious thoughts of leaving residency (odds ratio, 1.2; 95% CI, 1.1-1.3; P = .003). Eighty-six respondents were from historically high-attrition programs, and 202 respondents were from historically low-attrition programs (27.8% vs 8.4% 10-year attrition rate, P = .04). Residents from high-attrition programs were more likely to seriously consider leaving residency (odds ratio, 1.8; 95% CI, 1.0-3.0; P = .03). CONCLUSIONS AND RELEVANCE A majority of categorical general surgery residents seriously consider leaving residency. Female residents are more likely to consider leaving. Thoughts of leaving seem to be associated with work conditions on specific rotations rather than with overall work hours and are more prevalent among programs with historically high attrition rates.

Minimally invasive treatment of esophageal cancer: laparoscopic staging to robotic esophagectomy.

Minimally invasive surgical (MIS) procedures have become commonplace in modern surgical practice. The term minimally invasive surgery has been and continues to be interchangeably applied to describe laparoscopic, laparoscopic-assisted, thoracoscopic, and telesurgical (robotic) procedures. Minimally invasive surgical procedures for the treatment of benign and malignant disorders of the esophagus are being developed, refined, and clinically applied in parallel with the exponential availability of novel technologies and instrumentation. Herein, we review the progression from lapa-roscopic/thoracoscopic esophagectomy to telesurgical esophagectomy, presently termed minimally invasive esophagectomy, and describe the telesurgical procedure as well as early the clinical outcome experience.

Multicenter, prospective, longitudinal study of the recurrence, surgical site infection, and quality of life after contaminated ventral hernia repair using biosynthetic absorbable mesh: The COBRA study

OBJECTIVE The aim of the study was to evaluate biosynthetic absorbable mesh in single-staged contaminated (Centers for Disease Control class II and III) ventral hernia (CVH) repair over 24 months. BACKGROUND CVH has an increased risk of postoperative infection. CVH repair with synthetic or biologic meshes has reported chronic biomaterial infections and high hernia recurrence rates. METHODS Patients with a contaminated or clean-contaminated operative field and a hernia defect at least 9 cm had a biosynthetic mesh (open, sublay, retrorectus, or intraperitoneal) repair with fascial closure (n = 104). Endpoints included overall Kaplan-Meier estimates for hernia recurrence and postoperative wound infection rates at 24 months, and the EQ-5D and Short Form 12 Health Survey (SF-12). Analyses were conducted on the intent-to-treat population, and health outcome measures evaluated using paired t tests. RESULTS Patients had a mean age of 58 years, body mass index of 28 kg/m, 77% had contaminated wounds, and 84% completed 24-months follow-up. Concomitant procedures included fistula takedown (n = 24) or removal of infected previously placed mesh (n = 29). Hernia recurrence rate was 17% (n = 16). At the time of CVH repair, intraperitoneal placement of the biosynthetic mesh significantly increased the risk of recurrences (P ≤ 0.04). Surgical site infections (19/104) led to higher risk of recurrence (P < 0.01). Mean 24-month EQ-5D (index and visual analogue) and SF-12 physical component and mental scores improved from baseline (P < 0.05). CONCLUSIONS In this prospective longitudinal study, biosynthetic absorbable mesh showed efficacy in terms of long-term recurrence and quality of life for CVH repair patients and offers an alternative to biologic and permanent synthetic meshes in these complex situations.This is an open-access article distributed under the terms of the Creative Commons Attribution-Non Commercial-No Derivatives License 4.0, where it is permissible to download and share the work provided it is properly cited. The work cannot be changed in any way or used commercially. http://creativecommons.org/licenses/by-nc-nd/4.0.Objective: The aim of the study was to evaluate biosynthetic absorbable mesh in single-staged contaminated (Centers for Disease Control class II and III) ventral hernia (CVH) repair over 24 months. Background: CVH has an increased risk of postoperative infection. CVH repair with synthetic or biologic meshes has reported chronic biomaterial infections and high hernia recurrence rates. Methods: Patients with a contaminated or clean-contaminated operative field and a hernia defect at least 9 cm2 had a biosynthetic mesh (open, sublay, retrorectus, or intraperitoneal) repair with fascial closure (n = 104). Endpoints included overall Kaplan-Meier estimates for hernia recurrence and postoperative wound infection rates at 24 months, and the EQ-5D and Short Form 12 Health Survey (SF-12). Analyses were conducted on the intent-to-treat population, and health outcome measures evaluated using paired t tests. Results: Patients had a mean age of 58 years, body mass index of 28 kg/m2, 77% had contaminated wounds, and 84% completed 24-months follow-up. Concomitant procedures included fistula takedown (n = 24) or removal of infected previously placed mesh (n = 29). Hernia recurrence rate was 17% (n = 16). At the time of CVH repair, intraperitoneal placement of the biosynthetic mesh significantly increased the risk of recurrences (P ⩽ 0.04). Surgical site infections (19/104) led to higher risk of recurrence (P < 0.01). Mean 24-month EQ-5D (index and visual analogue) and SF-12 physical component and mental scores improved from baseline (P < 0.05). Conclusions: In this prospective longitudinal study, biosynthetic absorbable mesh showed efficacy in terms of long-term recurrence and quality of life for CVH repair patients and offers an alternative to biologic and permanent synthetic meshes in these complex situations.

Robotic surgery update

BackgroundMinimally invasive surgical techniques have revolutionized the field of surgery. Telesurgical manipulators (robots) and new information technologies strive to improve upon currently available minimally invasive techniques and create new possibilities.MethodsA retrospective review of all robotic cases at a single academic medical center from August 2000 until November 2002 was conducted. A comprehensive literature evaluation on robotic surgical technology was also performed.ResultsRobotic technology is safely and effectively being applied at our institution. Robotic and information technologies have improved upon minimally invasive surgical techniques and created new opportunities not attainable in open surgery.ConclusionsRobotic technology offers many benefits over traditional minimal access techniques and has been proven safe and effective. Further research is needed to better define the optimal application of this technology. Credentialing and educational requirements also need to be delineated.

Stoma size critical to 12-month outcomes in endoscopic suturing for gastric bypass repair

BACKGROUND Roux-en-Y gastric bypass (RYGB) is the most frequently performed bariatric procedure. However, weight regain after RYGB is common and often associated with pouch and stoma dilation. Historically, revision surgery has a greater risk of morbidity and mortality than the primary procedure. Endoscopic repair appears to be a safer option; however, current knowledge is limited regarding the longer term outcomes. Our objective was to prospectively collect the 12-month post-RYGB outcomes data after repair of dilated gastric tissue with an incisionless tissue approximation system in an open-label, single-group study at 9 U.S. sites. METHODS Adults ≥ 2 years after RYGB, with weight regain and pouch and/or stoma dilation underwent tissue plication with an endolumenal anchoring system to tighten dilated gastric tissue. The outcomes were captured, with statistical modeling used to identify the predictors of success. RESULTS Of the 116 subjects, 112 (97%) had anchors successfully placed (mean 5.9 anchors/subject). The mean stoma diameter and pouch length after the procedure was 11.5 mm (50% reduction) and 3.3 cm (44% reduction), respectively. At 12 months after repair (n = 73), the mean weight loss and percentage of excess weight loss was 5.9 ± 1.1 kg and 14.5% ± 3.1%, respectively. Anchor presence was confirmed endoscopically in 61 (92%) of 66 patients at 1 year. Those with a dilated stoma (>12 mm) who had a postrepair diameter of <10 mm (n = 22, 30% of 66) had more than double the excess weight loss compared with the rest of the cohort (24% versus 10%, P = .03). No serious adverse events occurred. CONCLUSION The 12-month outcomes have demonstrated the safety and durability of this method of gastric bypass repair. Aggressive reduction of stoma dilation was associated with superior weight loss.