Female Fertility Outcome Following Bariatric Surgery: Five Years Follow up

Completed

• Conditions: Female Fertility and Bariatric Surgery
• Interventions: Procedure: Laparoscopic Sleeve Gastrectomy

• Registration Number: NCT04392661
• Lead Sponsor: Tanta University

Brief Summary

Maternal morbid obesity is an important risk factor in modern obstetrics, it has been associated with higher infertility rates and obstetrics complications. Bariatric surgery proven to achieve long term weight loss with improvement in all obesity related morbidities. This study was to compare the 5 years outcomes of laparoscopic sleeve gastrectomy (LSG) and laparoscopic Roux-en-Y gastric bypass (LRYGB) in terms of fertility outcomes, breast feeding, weight loss, safety, and resolution of obesity related co-morbidity.

Detailed Description

This study included 197 adult morbidly obese females, 111 underwent LSG (group I) and 86 LRYGB (group II). After 5 years follow up, the following were looked at: percentage excess weight loss (%EWL), comorbidity improvement or resolution, postoperative complications or mortality, fertility outcomes and breast feeding.

Study Timeline

• Study Start: 2012-01
• Primary Completion: 2014-12
• Study Completion: 2019-08
• Status Verified: 2020-05
• Study First Submitted: 2020-05-14
• Study First Submitted QC: 2020-05-14
• Study First Posted: 2020-05-19
• Last Update Submitted: 2020-05-22
• Last Update Posted: 2020-05-27

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 197

Inclusion Criteria

• Patients with primary goal of conceiving and complaining from infertility either primary or secondary as well as those who were seeking weight loss in preparation for marriage

Exclusion Criteria

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Laparoscopic Sleeve Gastrectomy (group I)	Laparoscopic Sleeve Gastrectomy	111 morbid obese females underwent LSG (group I). After 5 years follow up, the following were looked at: percentage excess weight loss (%EWL), comorbidity improvement or resolution, postoperative complications or mortality, fertility outcomes and breast feeding.
Laparoscopic Roux-en-Y Gastric Bypass (group II)	Laparoscopic Sleeve Gastrectomy	86 morbid obese females underwent LRYGB (group II). After 5 years follow up, the following were looked at: percentage excess weight loss (%EWL), comorbidity improvement or resolution, postoperative complications or mortality, fertility outcomes and breast feeding.

Primary Outcome Measures

Name	Time	Method
Measuring the number of females that got pregnant from79 females seeking pregnancy	Five years follow-up	effect of LSG and LRYGB on female fertility and getting pregnant
percentage excess weight loss after bariatric surgery	Five years follow-up	effect of LSG and LRYGB on percentage excess weight loss after bariatric surgery on females

Secondary Outcome Measures

Name	Time	Method
comorbidity improvement or resolution after bariatric surgery	Five years follow-up	effect of LSG and LRYGB on comorbidities on females
postoperative complications or mortality after bariatric surgery	Five years follow-up	postoperative complications or mortality after LSG and LRYGB in obese females