WithdrawnNot Applicable

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

Stopped: No participants enrolled

0Started 2018-08-06

Plain-language 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.

Who can participate

Age range

19 Years – 70 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * Men and women age 19-70 who will receive their weight loss procedure at UNMC * BMI of 35-45 * RYGB as the primary procedure Exclusion Criteria: * RYGB performed as a revisional procedure * Prior foregut surgery * H/o smoking, unless the patient quit more than 10 years ago * Complication of bariatric procedure post-operatively that would significantly affect weight loss (extended period of TPN, clinically significant leak, major organ failure, severe protein malnutrition or failure to thrive)

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Stricture Rate

Timeframe: 1 year

Trial details

NCT IDNCT03199352

SponsorUniversity of Nebraska

Sponsor typeOTHER

Study typeOBSERVATIONAL

Primary completion2020-11-12

View on ClinicalTrials.gov More Roux-en-y Anastomosis Site trials