Female Fertility Outcome Following Bariatric Surgery: Five Years Follow up
1 other identifier
observational
197
0 countries
N/A
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for all trials
Started Jan 2012
Longer than P75 for all trials
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
January 1, 2012
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2014
CompletedStudy Completion
Last participant's last visit for all outcomes
August 1, 2019
CompletedFirst Submitted
Initial submission to the registry
May 14, 2020
CompletedFirst Posted
Study publicly available on registry
May 19, 2020
CompletedMay 27, 2020
May 1, 2020
2.9 years
May 14, 2020
May 22, 2020
Conditions
Outcome Measures
Primary Outcomes (2)
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 Outcomes (2)
comorbidity improvement or resolution after bariatric surgery
Five years follow-up
postoperative complications or mortality after bariatric surgery
Five years follow-up
Study Arms (2)
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.
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.
Interventions
bariatric surgeries and data collection
Eligibility Criteria
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.
You may qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Tanta Universitylead
Study Design
- Study Type
- observational
- Observational Model
- CASE CROSSOVER
- Time Perspective
- RETROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Lecturer of general and pediatric surgery
Study Record Dates
First Submitted
May 14, 2020
First Posted
May 19, 2020
Study Start
January 1, 2012
Primary Completion
December 1, 2014
Study Completion
August 1, 2019
Last Updated
May 27, 2020
Record last verified: 2020-05
Data Sharing
- IPD Sharing
- Will not share