Long Term Results After Sleeve Gastrectomy | NCT02947412

Studies
Long Term Results After Sleeve Gastrectomy

NCT02947412

Sponsor

Sana Klinikum Offenbach

Status

Completed

Last Update Posted

Apr 25, 2018Actual

Enrollment

40Actual

Phase

Not provided

Conditions

Obesity

Interventions

laparoscopic sleeve gastrectomy

Countries

Not provided

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Apr 2018

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jan 2007

Primary Completion Date

Dec 2015Actual

Completion Date

Oct 2016Actual

First Submitted Date

Oct 26, 2016

First Submission Date that Met QC Criteria

Oct 26, 2016

First Posted Date

Oct 27, 2016Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Apr 24, 2018

Last Update Posted Date

Apr 25, 2018Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Sonja Chiappetta, MD, Dr. Sonja Chiappetta, Dr. Christine Stier, Prof. Rudolf Weiner, Sana Klinikum OffenbachPrincipal Investigator

Lead Sponsor

Sana Klinikum OffenbachOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

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.

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.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

40Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
sleeve gastrectomy		laparoscopic sleeve gastrectomy	Other: laparoscopic sleeve gastrectomy

Interventions

Name	Type	Description	Arm Group Labels	Other Names
laparoscopic sleeve gastrectomy	Other	laparoscopic sleeve gastrectomy	sleeve gastrectomy

Outcomes Module

Primary Outcomes

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

Secondary Outcomes

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

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

s.a. sleeve gastrectomy since 2007

Exclusion Criteria:

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

65 Years

Standard Ages

AdultOlder Adult

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

Sampling Method

Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Rudolf A Weiner, Prof.	Sana Klinikum Offenbach	Study Director

Locations

Not provided

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
26316928	Background	Biter LU, Gadiot RP, Grotenhuis BA, Dunkelgrun M, van Mil SR, Zengerink HJ, Smulders JF, Mannaerts GH. The Sleeve Bypass Trial: a multicentre randomized controlled trial comparing the long term outcome of laparoscopic sleeve gastrectomy and gastric bypass for morbid obesity in terms of excess BMI loss percentage and quality of life. BMC Obes. 2015 Aug 26;2:30. doi: 10.1186/s40608-015-0058-0. eCollection 2015.
21890430

ID	Term
D050177	Overweight
D044343	Overnutrition
D009748	Nutrition Disorders
D009750	Nutritional and Metabolic Diseases