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Robotic Versus Laparoscopic Techniques for Revisional Bariatric Surgery

NCT03673410 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 60

Last updated 2018-09-17

No results posted yet for this study

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

Interventions

PROCEDURE

Robotic bariatric surgery - revisional

Using robotic techniques during any revesional bariatric surgery

PROCEDURE

Laparoscopic bariatric surgery - revisional

Using laparoscopic techniques during any revesional bariatric surgery

Sponsors & Collaborators

Principal Investigators

  • Dennis Hong, MD Msc · McMaster University

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
70 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-01-01
Primary Completion
2020-07-31
Completion
2025-07-31

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03673410 on ClinicalTrials.gov