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Impact of Bariatric Surgery in Patients With Morbid Obesity (IVBIA)

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ClinicalTrials.gov Identifier: NCT04009356
Recruitment Status : Not yet recruiting
First Posted : July 4, 2019
Last Update Posted : July 8, 2019
Sponsor:
Information provided by (Responsible Party):
Laurent BRUNAUD, Central Hospital, Nancy, France

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
Obesity, Morbid Anal Incontinence Image, Body 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.


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Study Type : Observational
Estimated 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
Estimated Study Start Date : August 1, 2019
Estimated Primary Completion Date : August 1, 2021
Estimated Study Completion Date : February 1, 2022

Resource links provided by the National Library of Medicine



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


Primary Outcome Measures :
  1. Prevalence of anal incontinence before and after bariatric surgery (%) [ Time Frame: 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) [ Time Frame: 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) [ Time Frame: 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) [ Time Frame: before and at 6 month postoperatively ]
    MRI



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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients who are scheduled for a bariatric surgical procedure after a multidisciplinary evaluation for about 1 year (following HAS national recommendations).
Criteria

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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04009356


Contacts
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Contact: agathe Postillon, MD 0383153109 ext +33 agathe.postillon@gmail.com
Contact: laurent Brunaud, MD 0383153109 ext +33 l.brunaud@chru-nancy.fr

Sponsors and Collaborators
Central Hospital, Nancy, France

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Responsible Party: Laurent BRUNAUD, Principal investigator, Professor of Surgery, Central Hospital, Nancy, France
ClinicalTrials.gov Identifier: NCT04009356     History of Changes
Other Study ID Numbers: ID-RCB:2019-A01229-48
First Posted: July 4, 2019    Key Record Dates
Last Update Posted: July 8, 2019
Last Verified: July 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Obesity, Morbid
Fecal Incontinence
Obesity
Overnutrition
Nutrition Disorders
Overweight
Body Weight
Signs and Symptoms
Rectal Diseases
Intestinal Diseases
Gastrointestinal Diseases
Digestive System Diseases