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IVBIA: Impact of Bariatric Surgery in Patients With Morbid Obesity

Sponsor
Central Hospital, Nancy, France (Other)
Overall Status
Completed
CT.gov ID
NCT04009356
Collaborator
(none)
300
Enrollment
1
Location
23.3
Actual Duration (Months)
12.9
Patients Per Site Per Month

Study Details

Study Description

Brief 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.

Condition or Disease Intervention/Treatment Phase
  • Procedure: bariatric surgical procedures

Detailed Description

This study is proposed to all obese patients evaluated for potential bariatric surgery during a multidisciplinary evaluation for about 1 year following current french national recommendations.

Demographics are collected from medical records (age, sex, weight, height, diabetes, sleep apnea syndrome, hypertension, lipid disorders, distal neuropathy, depression, number of pregnancies, history of vaginal delivery, traumatic delivery, caesarean section, hysterectomy, urinary incontinence surgery, proctologic surgery, presence of rectal prolapse (operated or not), cholecystectomy, digestive resection, menopause, history of urinary or fecal or gaseous leakage, current treatments, tobacco consumption, diet.

Data are collected by self-questionnaire to all included patient during the preoperative consultation (about 6 weeks before bariatric surgery) and during the 6-months postoperative clinical visit scheduled during the regular follow-up.

Study Design

Study Type:
Observational
Actual Enrollment :
300 participants
Observational Model:
Cohort
Time Perspective:
Prospective
Official Title:
Impact of Bariatric Surgery in Patients With Morbid Obesity. Prospective Study With Comparison Before and After
Actual Study Start Date :
Jan 22, 2020
Actual Primary Completion Date :
Aug 1, 2021
Actual Study Completion Date :
Jan 1, 2022

Outcome Measures

Primary Outcome Measures

  1. Prevalence of anal incontinence before and after bariatric surgery (%) [at 6 month postoperatively]

    PFDI-20 score (pelvic floor distress inventory) from zero to 12 (0: no incontinence and 12: severe incontinence)

Secondary Outcome Measures

  1. Severity of anal incontinence before and after surgery (score) [at 6 month postoperatively]

    PFDI-20 score (pelvic floor distress inventory) from zero to 12 (0: no incontinence and 12: severe incontinence)

  2. quality of life related to anal incontinence (score) [at 6 month postoperatively]

    PFIQ-7 (pelvic floor impact questionnaire) from 0 to 16 (0: no incontinence and 16: severe incontinence)

  3. Pelvic imaging (MRI) [before and at 6 month postoperatively]

    MRI

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 65 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
Inclusion Criteria:

  • BMI>40 kg/m2

  • BMI> 35 kg/m2 with comorbidity ( high blood pressure, diabetes, dyslipidemia, sleep apnea syndrome)

Exclusion Criteria:

  • anal incontinence due to chronic diarrhea

  • transit constipation

  • peripheral neuropathy (diabetes ...)

  • patient opposition

  • any previous bariatric surgical procedure

  • any pelvic surgical procedure performed during the study period (between preoperative and postoperative period at 6 months)

Contacts and Locations

Locations

Site City State Country Postal Code
1 CHRU Nancy - Département Chirurgie Viscérale, Métabolique et Cancérologique CVMC (7ème étage) Nancy France 54511

Sponsors and Collaborators

  • Central Hospital, Nancy, France

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Laurent BRUNAUD, Principal investigator, Professor of Surgery, Central Hospital, Nancy, France
ClinicalTrials.gov Identifier:
NCT04009356
Other Study ID Numbers:
  • ID-RCB:2019-A01229-48
First Posted:
Jul 5, 2019
Last Update Posted:
Mar 9, 2022
Last Verified:
Mar 1, 2022
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:
Fecal Incontinence
Obesity
Obesity, Morbid

Study Results

No Results Posted as of Mar 9, 2022