MedTrace Logo

Hand-sewn and Linear-stapled Roux-en-Y Gastric Bypass: Outcomes

NCT03199352 · Status: WITHDRAWN · Type: OBSERVATIONAL

Last updated 2023-08-22

No results posted yet for this study

Summary

The technique of laparoscopic Roux-en-Y gastric bypass (RYGB) has evolved significantly over the past few decades to minimize complication risks such as strictures. Three different anastomotic techniques are currently widely used hand-sewn (HS), linear-stapled (LS) and circular stapled (CS). Studies are contradictory as to the best technique to avoid complications. Many studies have focused on the stricture and infection rates of these procedures, and minimized the examination of ulceration, gastritis, and anastomotic leak. The purpose of this study is to prospectively examine how the use of linear-stapled and hand-sewn anastomotic techniques affect complication rates of marginal ulceration, gastritis, leak and stricture in patients who undergo RYGB. The goal of this study is to compare the long-term complication rates between hand-sewn robotic RYGB and linear-stapled laparoscopic RYGB. Eligible patients are men and women age 19-65 who are to undergo RYGB, have a BMI between 35-45, and RYGB is the primary procedure. The main outcomes to be measured are complications in marginal ulceration, gastritis, leak, and stricture rate at 2 and 6 weeks, and 3, 6, 9, 12, and 24 months postoperatively.

Conditions

  • Roux-en-y Anastomosis Site

Interventions

OTHER

RYGB hand-sewn

Patients will have the RYGB anastomosis hand-sewn

OTHER

RYGB linear-staple

Patients will have the RYGB anastomosis performed using a linear staple.

Sponsors & Collaborators

  • University of Nebraska

    lead OTHER

Principal Investigators

  • Vishal Kothari, MD · University of Nebraska

Eligibility

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

Timeline & Regulatory

Start
2018-08-06
Primary Completion
2020-11-12
Completion
2020-11-12

More Related Trials

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 NCT03199352 on ClinicalTrials.gov