Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03199352
Recruitment Status : Enrolling by invitation
First Posted : June 26, 2017
Last Update Posted : May 2, 2019
Sponsor:
Information provided by (Responsible Party):
Vishal Kothari, University of Nebraska

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.

Condition or disease Intervention/treatment
Roux-en-y Anastomosis Site Other: RYGB hand-sewn Other: RYGB linear-staple

  Show Detailed Description

Layout table for study information
Study Type : Observational
Estimated Enrollment : 63 participants
Observational Model: Other
Time Perspective: Prospective
Official Title: Comparison of Hand-sewn and Linear-stapled Roux-en-Y Gastric Bypass: Outcomes in Stricture, Ulceration, and Gastritis
Actual Study Start Date : August 6, 2018
Estimated Primary Completion Date : July 31, 2020
Estimated Study Completion Date : July 31, 2020

Group/Cohort Intervention/treatment
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
Patients will have the RYGB anastomosis 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
Patients will have the RYGB anastomosis performed using a linear staple.




Primary Outcome Measures :
  1. Stricture Rate [ Time Frame: 1 year ]
    Examine the development of stricture at the anastomosis. Stricture will be determined by esophagogastroduodenoscopy (EGD) at 1 year post-surgery.


Secondary Outcome Measures :
  1. Leak rate [ Time Frame: 1 year ]
    Examine leak development at the anastomosis site. Leak is determined by clinical findings of pain, tachycardia, fever, and confirmed by a barium swallow study that indicates a hole at the anastomosis site

  2. Quality of Life impact [ Time Frame: 1 year ]
    Examine the quality of life impact of the surgery, using the SF-36 questionnaire



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   19 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Sampling Method:   Probability Sample
Study Population
Eligible participants who have access to care at UNMC.
Criteria

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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03199352


Locations
Layout table for location information
United States, Nebraska
University of Nebraska Medical Center
Omaha, Nebraska, United States, 68198
University of Nebraska Medical Center
Omaha, Nebraska, United States, 986245
Sponsors and Collaborators
University of Nebraska

Layout table for additonal information
Responsible Party: Vishal Kothari, Assistant Professor of Surgery, University of Nebraska
ClinicalTrials.gov Identifier: NCT03199352     History of Changes
Other Study ID Numbers: 280-17-FB
First Posted: June 26, 2017    Key Record Dates
Last Update Posted: May 2, 2019
Last Verified: April 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: We do not currently plan to make individual participant data available to other researchers.

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No