Clinical trial NCT02947412: Long Term Results After Sleeve Gastrectomy
Official title: Long Term Results After Sleeve Gastrectomy as a Primary Procedure in Obesity Surgery
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Obesity
Keywords: sleeve gastrectomy
long-term follow-up
gastroesophageal reflux disease after sleeve
revisional surgery
Lead sponsor: Sana Klinikum Offenbach
Sponsor class: OTHER
First posted: 2016-10-27
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: RETROSPECTIVE
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

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.

Eligibility criteria: Inclusion Criteria:

* s.a. sleeve gastrectomy since 2007

Exclusion Criteria:

-

Primary outcomes:
measure: Incidence of revisional surgery
timeFrame: up to 9 years after surgery
Secondary outcomes:
measure: Excess weight loss in %
timeFrame: up to 9 years after surgery
measure: Incidence of Gastroesophageal Reflux Disease
timeFrame: up to 9 years after surgery
Other outcomes:
Locations:
Study officials:
affiliation: Sana Klinikum Offenbach
name: Rudolf A Weiner, Prof.
role: STUDY_DIRECTOR
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.