Long Term Results After Sleeve Gastrectomy

April 24, 2018 updated by: Sonja Chiappetta, MD, Sana Klinikum Offenbach

Long Term Results After Sleeve Gastrectomy as a Primary Procedure in Obesity Surgery

Today sleeve gastrectomy is the most performed bariatric procedure worldwide. Since 2005 it is gaining popularity as a single procedure. Long term data is scarce. In this retrospective study long term follow-up in relation to weight loss, comorbidities, re-do and revisional surgery is getting analyzed.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Today sleeve gastrectomy is the most performed bariatric procedure worldwide. Since 2005 it is gaining popularity as a single procedure. Long term data is scarce.

Re-Do and revisional surgery in form of re-sleeve, gastric bypass (mini -gastric bypass, roux-en y gastric bypass) and biliopancreatic diversion (BPD) is described in the current literature due to weight regain and reflux. The investigators want to analyze the frequency of this re-do/revisional surgery and want to compare weight loss and improvement in comorbidities.

Study Type

Observational

Enrollment (Actual)

40

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 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

Patients who underwent sleeve gastrectomy since 2007, being the first szrgical treatment for severe obesity are studied in the long term follow-up

Description

Inclusion Criteria:

  • s.a. sleeve gastrectomy since 2007

Exclusion Criteria:

-

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

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
sleeve gastrectomy
laparoscopic sleeve gastrectomy
Other: laparoscopic sleeve gastrectomy
laparoscopic sleeve gastrectomy

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Incidence of revisional surgery
Time Frame: up to 9 years after surgery
up to 9 years after surgery

Secondary Outcome Measures

Outcome Measure
Time Frame
Excess weight loss in %
Time Frame: up to 9 years after surgery
up to 9 years after surgery
Incidence of Gastroesophageal Reflux Disease
Time Frame: up to 9 years after surgery
up to 9 years after surgery

Collaborators and Investigators

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

Sponsor

Sana Klinikum Offenbach

Investigators

  • Study Director: Rudolf A Weiner, Prof., Sana Klinikum Offenbach

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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

January 1, 2007

Primary Completion (Actual)

December 1, 2015

Study Completion (Actual)

October 1, 2016

Study Registration Dates

First Submitted

October 26, 2016

First Submitted That Met QC Criteria

October 26, 2016

First Posted (Estimate)

October 27, 2016

Study Record Updates

Last Update Posted (Actual)

April 25, 2018

Last Update Submitted That Met QC Criteria

April 24, 2018

Last Verified

April 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • FF 1/2016

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

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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