NCT02947412

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.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
40

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Jan 2007

Longer than P75 for all trials

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2007

Completed
8.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2015

Completed
10 months until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2016

Completed
25 days until next milestone

First Submitted

Initial submission to the registry

October 26, 2016

Completed
1 day until next milestone

First Posted

Study publicly available on registry

October 27, 2016

Completed
Last Updated

April 25, 2018

Status Verified

April 1, 2018

Enrollment Period

8.9 years

First QC Date

October 26, 2016

Last Update Submit

April 24, 2018

Conditions

Keywords

sleeve gastrectomylong-term follow-upgastroesophageal reflux disease after sleeverevisional surgery

Outcome Measures

Primary Outcomes (1)

  • Incidence of revisional surgery

    up to 9 years after surgery

Secondary Outcomes (2)

  • Excess weight loss in %

    up to 9 years after surgery

  • Incidence of Gastroesophageal Reflux Disease

    up to 9 years after surgery

Study Arms (1)

sleeve gastrectomy

laparoscopic sleeve gastrectomy

Other: laparoscopic sleeve gastrectomy

Interventions

laparoscopic sleeve gastrectomy

sleeve gastrectomy

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability 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

You may qualify if:

  • s.a. sleeve gastrectomy since 2007

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (5)

  • 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.

    PMID: 26316928BACKGROUND
  • Sarela AI, Dexter SP, O'Kane M, Menon A, McMahon MJ. Long-term follow-up after laparoscopic sleeve gastrectomy: 8-9-year results. Surg Obes Relat Dis. 2012 Nov-Dec;8(6):679-84. doi: 10.1016/j.soard.2011.06.020. Epub 2011 Jul 20.

    PMID: 21890430BACKGROUND
  • Abelson JS, Afaneh C, Dolan P, Chartrand G, Dakin G, Pomp A. Laparoscopic Sleeve Gastrectomy: Co-morbidity Profiles and Intermediate-Term Outcomes. Obes Surg. 2016 Aug;26(8):1788-93. doi: 10.1007/s11695-015-2002-2.

  • Ramos AC, Bastos EL, Ramos MG, Bertin NT, Galvao TD, de Lucena RT, Campos JM. MEDIUM-TERM FOLLOW-UP RESULTS WITH LAPAROSCOPIC SLEEVE GASTRECTOMY. Arq Bras Cir Dig. 2015;28 Suppl 1(Suppl 1):61-4. doi: 10.1590/S0102-6720201500S100017.

  • Perrone F, Bianciardi E, Benavoli D, Tognoni V, Niolu C, Siracusano A, Gaspari AL, Gentileschi P. Gender Influence on Long-Term Weight Loss and Comorbidities After Laparoscopic Sleeve Gastrectomy and Roux-en-Y Gastric Bypass: a Prospective Study With a 5-Year Follow-up. Obes Surg. 2016 Feb;26(2):276-81. doi: 10.1007/s11695-015-1746-z.

MeSH Terms

Conditions

Obesity

Condition Hierarchy (Ancestors)

OverweightOvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Rudolf A Weiner, Prof.

    Sana Klinikum Offenbach

    STUDY DIRECTOR

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Dr. Sonja Chiappetta, Dr. Christine Stier, Prof. Rudolf Weiner

Study Record Dates

First Submitted

October 26, 2016

First Posted

October 27, 2016

Study Start

January 1, 2007

Primary Completion

December 1, 2015

Study Completion

October 1, 2016

Last Updated

April 25, 2018

Record last verified: 2018-04

Data Sharing

IPD Sharing
Will not share