Evaluation of Patients Who Underwent Sleeve Gastrectomy With Jejunoileal Anastomosis for the Treatment of Morbid Obesity

September 29, 2019 updated by: cihan gokler, Inonu University
Laparoscopic sleeve gastrectomy operations performed for morbid obesity are among the most common methods in the world. Gastric or intestinal bypass surgery with or without sleeve gastrectomy is thought to be more effective in controlling both weight loss and metabolic diseases. For this purpose, Roux-en-y gastric bypass, transit bipartition, duodenal switch, jejunoileal bypass are performed. The aim of this study was to evaluate the effects of jejunoileal bypass surgery on weight loss and metabolic diseases in patients with sleeve gastrectomy.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Bariatric surgery results in more and more long-term weight loss than traditional treatment in moderate and severe obesity. Due to morbid obesity, jejunoileal bypass has been applied since 1970. Laparoscopic sleeve gastrectomy and jejunoileal anastomosis are among the rare techniques described in 2012. There are few studies on this technique.

Between 2015 and 2018, jejunoileal bypass operations with laparoscopic sleeve gastrectomy for morbid obesity will be evaluated in Inonu University gastroenterology surgery clinic. The patients' age, gender, body mass index, weight loss in follow-up periods, whether there is back weight gain, the effects on metabolic diseases, early and late complications will be evaluated.

Study Type

Observational

Enrollment (Actual)

2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Turkey
      • Malatya, Turkey, 4090
        • Cihan Gökler

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 60 years (ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

Patients aged between 18 and 60 years with a body mass index greater than 40, no comorbidity or a body mass index of 35-40, with a comorbidity (diabetes mellitus, hypertension, obstructive sleep apnea)

Description

Inclusion Criteria:All patients who underwent the sleeve gastrectomy with jejunoileal bypass between 2015-2018 for the treatment morbid obesity

Exclusion Criteria:other operations for morbid obesity except sleeve gastrectomy with jejunoileal bypass

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Excess weight loss
Time Frame: 2 years
body mass index (BMI) 25 was considered ideal. The ratio of the value above this value to the value that arrived at the end of 2 years was calculated. Over 80% was considered successful.
2 years
diabetes remission
Time Frame: 2 years
  1. Complete remission absence antidiabetic medications, HbA1c level below 6%, fasting blood glucose value below 100 mg / dl
  2. partial remission Subdiabetic hyperglycemia (HbA1c 6%-6.4%, FBG 100-125 mg/dL) in the absence antidiabetic medications
  3. Unchanged The absence of remission or improvement as described earlier
2 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Inonu University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

February 10, 2019

Primary Completion (ACTUAL)

May 3, 2019

Study Completion (ACTUAL)

May 3, 2019

Study Registration Dates

First Submitted

May 3, 2019

First Submitted That Met QC Criteria

May 3, 2019

First Posted (ACTUAL)

May 6, 2019

Study Record Updates

Last Update Posted (ACTUAL)

October 1, 2019

Last Update Submitted That Met QC Criteria

September 29, 2019

Last Verified

May 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2019/3-10

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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