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

NCT03199352 | Withdrawn

• 1 other identifier: 0280-17-FB
• Study Type: observational
• Target: N/A
• Locations: 0 countries
• Sites: N/A

Brief 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

Outcome Measures

Primary Outcomes (1)

• Stricture Rate

  Examine the development of stricture at the anastomosis. Stricture will be determined by esophagogastroduodenoscopy (EGD) at 1 year post-surgery.

  1 year

Secondary Outcomes (2)

• Leak rate

  1 year

• Quality of Life impact

  1 year

Study Arms (2)

RYGB: Hand-sewn

This group would receive a Roux-en-y gastric bypass with the anastomosis hand-sewn using a minimally-invasive robotic surgical approach

Other: RYGB hand-sewn

RYGB: linear-staple

This group would receive a Roux-en-y gastric bypass with the anastomosis sewn with a linear stapler using a laparoscopic surgical approach

Other: RYGB linear-staple

Interventions

RYGB hand-sewn OTHER

Patients will have the RYGB anastomosis hand-sewn

RYGB: Hand-sewn

RYGB linear-staple OTHER

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

RYGB: linear-staple

Eligibility Criteria

• Age: 19 Years - 70 Years
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Eligible participants who have access to care at UNMC.

You may qualify if:

• Men and women age 19-70 who will receive their weight loss procedure at UNMC
• BMI of 35-45
• RYGB as the primary procedure

You may not qualify if:

• 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)

Sponsors & Collaborators

• University of Nebraska: lead

Study Officials

• Vishal Kothari, MD

  University of Nebraska

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 22, 2017
• First Posted: June 26, 2017
• Study Start: August 6, 2018
• Primary Completion: November 12, 2020
• Study Completion: November 12, 2020
• Last Updated: August 22, 2023

Record last verified: 2023-08

Data Sharing

• IPD Sharing: Will not share