Robotic Versus Laparoscopic Techniques for Revisional Bariatric Surgery

NCT03673410 | Unknown

• 1 other identifier: Robotic revisional surgery
• Study Type: interventional
• Target: 60
• Locations: 0 countries
• Sites: N/A

Brief Summary

Obesity has become a significant health problem in Canada. When conservative efforts to lose weight fail, bariatric surgical procedures are often considered. Today, the most common bariatric procedures in North America are Laparoscopic Roux-en-Y gastric bypass (LRYGB) and Laparoscopic Sleeve Gastrectomy (LSG). For many reasons, an initial bariatric procedure may require surgical revision. Some reasons include weight regain, failed weight loss or other acute and chronic complications not related to weight loss. In these cases, it may be indicated that a procedure be reversed inor converted to another type of bariatric procedure. Regardless of the planned intervention, revisional surgery is always more difficult than the initial procedure mainly due to surgical scarring and altered anatomy. Though revisional bariatric surgery has been shown to be safe, our hope is to improve the safety profile by utilizing robotic surgery. Robotic surgery can facilitate more complex procedures by providing superior imaging and freedom of movement during the procedure. The aim of our study is to evaluate prospectively the outcomes of robotic compared to laparoscopic revisional bariatric surgery in terms of perioperative outcomes such as complication rates, operative time and readmissions as well as weight loss/comorbidity resolution (diabetes, hypertension, sleep apnea) where applicable.

Conditions

Bariatric Surgery; Robotic Surgery

Outcome Measures

Primary Outcomes (3)

• Short term complication rate

  Any complication - Complication will be defined by the Clavien-Dindo classification and our primary outcome will be long-term complications higher than grade III. These will include leaks and bleeds. Only complications related to the procedure, such as therapeutic endoscopy or reoperation will be counted. 3\)

  30 days from surgery

• Readmission

  Readmission to the center within 30 days of the original procedure

  30 days from surgery

• Long-term reintervention

  Reinterventions for chronic surgical complications (such as stricture) will be assessed through the bariatric clinic. Only reintenrtventinos related to the original procedure will be counted.

  5 years

Secondary Outcomes (5)

• Weight loss in kgs

  1, 3, 5 years

• BMI change (in kg/m2)

  1, 3 and 5 years

• Diabetes resolution

  1, 3 and 5 years

• Hypertension resolution

  1, 3, and 5 years

• Sleep apnea resolution

  1, 3, and 5 years

Study Arms (2)

Laparoscopic revisional bariatric surgery

ACTIVE COMPARATOR

Patients requiring revisional bariatric surgery will be treated with a standard of care laparoscopic procedure.

Procedure: Laparoscopic bariatric surgery - revisional

Robotic revisional bariatric surgery

EXPERIMENTAL

Patients requiring revisional bariatric surgery will be treated with the same procedure but performed robotically.

Procedure: Robotic bariatric surgery - revisional

Interventions

Robotic bariatric surgery - revisional PROCEDURE

Using robotic techniques during any revesional bariatric surgery

Robotic revisional bariatric surgery

Laparoscopic bariatric surgery - revisional PROCEDURE

Using laparoscopic techniques during any revesional bariatric surgery

Laparoscopic revisional bariatric surgery

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• The subject previously met National Institutes of Health criteria for bariatric surgery11 and received a bariatric surgical procedure.
• The subject is under consideration to undergo a revisional bariatric procedure after for failed sustained weight loss, weight regain or other chronic issues requiring revision.
• The subject is able and willing to give written consent
• The subject must be 18-70 years of age
• The subject must be willing and able to participate in the study procedures and to understand and sign the informed consent

You may not qualify if:

• The subject has a contraindication to general anesthesia
• The revision does not occur within the first 90 days of the initial bariatric procedure
• The subject has any medical condition, which in the judgment of the Investigator and/or designee makes the subject a poor candidate for the investigational procedure
• The subject is a pregnant or lactating female (Women of child bearing potential must take a pregnancy test prior to surgery)
• The subject has an history of alcohol abuse (\>30 g/day in men or \>20 g/day in women)
• Any subject who is considered to be part of a vulnerable population (e.g. prisoners or those with psychological concerns or those without sufficient mental capacity)
• The subject is unable or unwilling to comply with the study requirements or follow-up schedule
• The subject has conditions which, in the opinion of the investigator, will not be appropriate for the study (e.g. severe cardiovascular disease, history of gastrointestinal (GI) malignancy, history of upper GI surgery, open cholecystectomy, history of intestinal surgery, immunosuppression, or non-ambulatory)
• The subject has an estimated life expectancy of less than 6 months

Sponsors & Collaborators

• McMaster University: lead

Study Officials

• Dennis Hong, MD Msc

  McMaster University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Karen Barlow

CONTACT

905-522-1155; kbarlow@stjosham.on.ca

Dennis Hong, MD MSc

CONTACT

(905) 522-1155; dennishong70@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Once consent has been signed, the patient will be assigned to any of the two groups, using a computer-based randomization on REDCap and the patient will be assigned to the corresponding study arm.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: We will randomise 60 patients between robotic (30 patients) and laparoscopic revisional bariatric surgery (30 patients) to evaluate those procedures in terms of perioperative safety, weight loss and comorbidity resolution.

Study Record Dates

• First Submitted: September 5, 2018
• First Posted: September 17, 2018
• Study Start: January 1, 2019
• Primary Completion: July 31, 2020
• Study Completion: July 31, 2025
• Last Updated: September 17, 2018

Record last verified: 2018-09

Data Sharing

• IPD Sharing: Will not share