Impact of Bariatric Surgery in Patients With Morbid Obesity

Obesity, Morbid Clinical Trial

— IVBIA  

Official title:

Impact of Bariatric Surgery in Patients With Morbid Obesity. Prospective Study With Comparison Before and After

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04009356
• Other study ID #: ID-RCB:2019-A01229-48
• Status: Completed
• Start date: January 22, 2020
• Est. completion date: January 1, 2022

Study information

• Verified date: March 2022
• Source: Central Hospital, Nancy, France
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 300
• Est. completion date: January 1, 2022
• Est. primary completion date: August 1, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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)

Related Conditions & MeSH terms

• Anal Incontinence
• Fecal Incontinence
• Image, Body
• Obesity
• Obesity, Morbid

Intervention

Procedure:
• bariatric surgical procedures
gastric bypass, sleeve, banding,biliopancreatic diversion

Locations

Country	Name	City	State
France	CHRU Nancy - Département Chirurgie Viscérale, Métabolique et Cancérologique CVMC (7ème étage)	Nancy

Sponsors (1)

Lead Sponsor	Collaborator
Central Hospital, Nancy, France

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Prevalence of anal incontinence before and after bariatric surgery (%)	PFDI-20 score (pelvic floor distress inventory) from zero to 12 (0: no incontinence and 12: severe incontinence)	at 6 month postoperatively
Secondary	Severity of anal incontinence before and after surgery (score)	PFDI-20 score (pelvic floor distress inventory) from zero to 12 (0: no incontinence and 12: severe incontinence)	at 6 month postoperatively
Secondary	quality of life related to anal incontinence (score)	PFIQ-7 (pelvic floor impact questionnaire) from 0 to 16 (0: no incontinence and 16: severe incontinence)	at 6 month postoperatively
Secondary	Pelvic imaging (MRI)	MRI	before and at 6 month postoperatively