Female Fertility Outcome Following Bariatric Surgery: Five Years Follow up

NCT ID: NCT04392661

Last Updated: 2020-05-27

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

197 participants

Study Classification

OBSERVATIONAL

Study Start Date

2012-01-31

Study Completion Date

2019-08-31

Brief Summary

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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

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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.

Conditions

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Female Fertility and Bariatric Surgery

Study Design

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Observational Model Type

CASE_CROSSOVER

Study Time Perspective

RETROSPECTIVE

Study Groups

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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 Sleeve Gastrectomy

Intervention Type PROCEDURE

bariatric surgeries and data collection

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.

Laparoscopic Sleeve Gastrectomy

Intervention Type PROCEDURE

bariatric surgeries and data collection

Interventions

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Laparoscopic Sleeve Gastrectomy

bariatric surgeries and data collection

Intervention Type PROCEDURE

Other Intervention Names

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Laparoscopic Roux-en-Y Gastric Bypass

Eligibility Criteria

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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

\-
Minimum Eligible Age

18 Years

Maximum Eligible Age

40 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Tanta University

OTHER

Sponsor Role lead

Responsible Party

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Mohamed Ali Shehata

Lecturer of general and pediatric surgery

Responsibility Role PRINCIPAL_INVESTIGATOR

Other Identifiers

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Fertility & bariatric surgery

Identifier Type: -

Identifier Source: org_study_id

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