Female Fertility Outcome Following Bariatric Surgery: Five Years Follow up

Female Fertility Outcome Following Bariatric Surgery: Five Years Follow up, Single Center Study

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.

Study Overview

• Status: Completed
• Conditions: Female Fertility and Bariatric Surgery
• Intervention / Treatment: Procedure: Laparoscopic Sleeve Gastrectomy

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 Type: Observational
• Enrollment (Actual): 197

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 40 years (Adult)
• Accepts Healthy Volunteers: N/A
• Genders Eligible for Study: Female

• Sampling Method: Non-Probability Sample

Study Population

In the LSG group, 14 patients (12.6%) suffered from infertility, and 24 patients (21.6%) were at pre-marriage stage. This is versus 15 patients (17.4%), and 26 patients (30.2%) in the LRYGB group respectively.

Description

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 Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Laparoscopic Sleeve Gastrectomy (group I); 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.	Procedure: Laparoscopic Sleeve Gastrectomy; bariatric surgeries and data collection; Other Names: Laparoscopic Roux-en-Y Gastric Bypass
Laparoscopic Roux-en-Y Gastric Bypass (group II); 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.	Procedure: Laparoscopic Sleeve Gastrectomy; bariatric surgeries and data collection; Other Names: Laparoscopic Roux-en-Y Gastric Bypass

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Tanta University

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2012
• Primary Completion (Actual): December 1, 2014
• Study Completion (Actual): August 1, 2019

Study Registration Dates

• First Submitted: May 14, 2020
• First Submitted That Met QC Criteria: May 14, 2020
• First Posted (Actual): May 19, 2020

Study Record Updates

• Last Update Posted (Actual): May 27, 2020
• Last Update Submitted That Met QC Criteria: May 22, 2020
• Last Verified: May 1, 2020

More Information

Terms related to this study

• Other Study ID Numbers: Fertility & bariatric surgery

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No