Obesity, MorbidIVBIANCT04009356
Impact of Bariatric Surgery in Patients With Morbid Obesity
An observational study of Obesity, Morbid and Anal Incontinence, run by Central Hospital, Nancy, France at 1 site in France.
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). Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Obesity, Morbid, Anal Incontinence, Image, Body
- What is being tested?
- bariatric surgical procedures
- Type of treatment
- Surgery or procedure
- How many people
- 300 participants
- Where
- 1 siteFrance
- Study dates
- 22 Jan 2020to 1 Jan 2022
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients who are scheduled for a bariatric surgical procedure after a multidisciplinary evaluation for about 1 year (following HAS national recommendations).
Who may be able to join
- BMI>40 kg/m2
- BMI> 35 kg/m2 with comorbidity ( high blood pressure, diabetes, dyslipidemia, sleep apnea syndrome)
Who cannot join
- 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)
Trial locations and contacts
1 site in 1 country.
France1 site
CHRU Nancy - Département Chirurgie Viscérale, Métabolique et Cancérologique CVMC (7ème étage)
Nancy, 54511
About this study
Official title: Impact of Bariatric Surgery in Patients With Morbid Obesity. Prospective Study With Comparison Before and After
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).
Read more
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.
Read the 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.
- Conditions
- Obesity, Morbid, Anal Incontinence, Image, Body
- Being tested
- bariatric surgical procedures
- Medical subject headings
- Obesity, Morbid, Encopresis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
bariatric surgical proceduresProcedure or surgery
gastric bypass, sleeve, banding,biliopancreatic diversion
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: at 6 month postoperatively
Secondary outcomes (3)
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)
Measured: at 6 month postoperatively
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)
Measured: at 6 month postoperatively
Pelvic imaging (MRI)
MRI
Measured: before and at 6 month postoperatively
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jul 2019
- Study start22 Jan 2020
- Primary completion1 Aug 2021
- Study completion1 Jan 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Obesity, MorbidStudies of the same condition, open and under way.
- More trials run by Central Hospital, Nancy, FranceThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 300 participants (actual)
Sponsor and investigators
- Lead sponsor
- Central Hospital, Nancy, France
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Laurent BRUNAUD, Central Hospital, Nancy, France
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04009356
- Sponsor's protocol ID
- ID-RCB:2019-A01229-48
- Acronym
- IVBIA
- Status last verified
- Mar 2022
- First submitted
- 20 Jun 2019
- Last updated
- 9 Mar 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Mar 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Bariatric Surgery in Patients With Morbid Obesity. Prospective Study With Comparison Before and After
- ClinicalTrials.gov ID
- NCT04009356
- Acronym / sponsor ID
- IVBIA / ID-RCB:2019-A01229-48
- Conditions
- Obesity, Morbid, Anal Incontinence, Image, Body
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 300 participants (actual)
- Lead sponsor
- Central Hospital, Nancy, FranceUniversity, hospital or other
- Study start
- 22 Jan 2020 (actual)
- Primary completion
- 1 Aug 2021 (actual)
- Study completion
- 1 Jan 2022 (actual)
- First posted
- 5 Jul 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients who are scheduled for a bariatric surgical procedure after a multidisciplinary evaluation for about 1 year (following HAS national recommendations).
Key inclusion criteria (2 listed)
- BMI>40 kg/m2
- BMI> 35 kg/m2 with comorbidity ( high blood pressure, diabetes, dyslipidemia, sleep apnea syndrome)
Key exclusion criteria (6 listed)
- anal incontinence due to chronic diarrhea
- transit constipation
- peripheral neuropathy (diabetes ...)
- patient opposition
- any previous bariatric surgical procedure
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| bariatric surgical proceduresgastric bypass, sleeve, banding,biliopancreatic diversion | Procedure or surgery | – |
Primary outcome
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)
3 secondary outcomes
Severity of anal incontinence before and after surgery (score)
Time frame: at 6 month postoperatively
quality of life related to anal incontinence (score)
Time frame: at 6 month postoperatively
Pelvic imaging (MRI)
Time frame: before and at 6 month postoperatively
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Mar 2022.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Obesity, Morbid and Anal Incontinence, run by Central Hospital, Nancy, France at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 9 Mar 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Prevalence of anal incontinence before and after bariatric surgery (%) (time frame: at 6 month postoperatively). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Mar 2022.