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Impact of Bariatric Surgery in Patients With Morbid Obesity

NCT04009356 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 300

Last updated 2022-03-09

No results posted yet for this study

Summary

The main objective is to compare the prevalence of anal incontinence (AI) before and after bariatric surgery in obese patients.

Inclusion: Patients who are scheduled for a bariatric surgical procedure after a multidisciplinary evaluation for about 1 year (following french national recommendations).

Primary objective: After inclusion, all patients will fill in a specific self-questionnaire evaluating AI (PFDI-20 score) before surgery and at 6 months after surgery.

Investigators will evaluate the prevalence of anal incontinence before and at 6months after surgery using this PFDI- 20 score.

In those patients with preoperative anal incontinence (only in patients with 3 positive answers to question n°9,10, and 11 of PFDI-20 score self-questionnaire), a pelvic MRI will be performed before and at 6 months after surgery. Consequently, no further imaging exam will be performed in patients without preoperative anal incontinence (less than 3 positive answers to question n°9,10, and 11),

Secondary objectives:

* to evaluate the AI severity variation before and at 6 months after bariatric surgery regarding the percentage of postoperative weight loss.
* to compare the quality of life (PFIQ-7 score) related to AI day before and at 6 months after bariatric surgery.

Conditions

  • Obesity, Morbid
  • Anal Incontinence
  • Image, Body

Interventions

PROCEDURE

bariatric surgical procedures

gastric bypass, sleeve, banding,biliopancreatic diversion

Sponsors & Collaborators

  • Central Hospital, Nancy, France

    lead OTHER

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-01-22
Primary Completion
2021-08-01
Completion
2022-01-01

Countries

  • France

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04009356 on ClinicalTrials.gov