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Sponsored by: |
Assistance Publique - Hôpitaux de Paris |
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Information provided by: | Assistance Publique - Hôpitaux de Paris |
ClinicalTrials.gov Identifier: | NCT00632567 |
Anal incontinence is frequent and treatment is difficult. One of the most important reason is traumatic delivery.
10 % of women develop anal incontinence after first delivery. This incidence is higher after second vaginal delivery, particularly if the first delivery had break anal sphincter. One of the possibility to avoid anal incontinence is the caesarean section. So, do we have to recommend caesarean section for second delivery if the first was traumatic. But caesarean section had a morbidity. Actually, the choice between the delivery modalities is very subjective.
Condition | Intervention |
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Fecal Incontinence |
Procedure: caesarean section Procedure: vaginal delivery |
Study Type: | Interventional |
Study Design: | Prevention, Randomized, Open Label, Active Control, Parallel Assignment, Efficacy Study |
Official Title: | Anal Incontinence After Delivery. Secondary Prevention With Caesarean Section. |
Estimated Enrollment: | 369 |
Study Start Date: | March 2008 |
Estimated Study Completion Date: | July 2011 |
Estimated Primary Completion Date: | July 2011 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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1: Experimental
caesarean section
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Procedure: caesarean section
caesarean section for second delivery if the first had to be traumatic after forceps with anal sphincter rupture diagnosed with anal endosonography.
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2: Active Comparator
vaginal delivery
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Procedure: vaginal delivery
vaginal delivery for second delivery if the first had to be traumatic after forceps with anal sphincter rupture diagnosed with anal endosonography.
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Anal incontinence is frequent and treatment is difficult. One of the most important reason is traumatic delivery.
10 % of women develop anal incontinence after first delivery. This incidence is higher after second vaginal delivery, particularly if the first delivery had break anal sphincter. One of the possibility to avoid anal incontinence is the caesarean section. So, do we have to recommend caesarean section for second delivery if the first was traumatic. But caesarean section had a morbidity. Actually, the choice between the delivery modalities is very subjective.It seems to be very useful to compare, in randomize control study, global morbidity of caesarean section and vaginal delivery for second delivery if the first had to be traumatic after forceps with anal sphincter rupture diagnosed with anal endosonography. The primary endpoint is comparison of median incontinence score of VAISEY in the two arms after 6 months. The secondary endpoints are urinary incontinence, quality of life and global morbidity between the two arms after second delivery. We estimated, we need 129 women in each arm. Hospital investigators are : BICHAT Claude Bernard (Pr MADELENAT), Rothschild (Pr BENIFLA) and Jean VERDIER (Pr UZAN). Inclusion will be for 2 years and 3 months. Women will be included during the last trimester and evaluation will be perform on 8 weeks, 6 and 12 month after delivery.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Female |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contact: Laurent ABRAMOWITZ, MD | +33(0)1 40 25 80 80 ext bip 2225 | laurent.abramowitz@bch.aphp.fr |
France | |
Hopital BICHAT | Recruiting |
PARIS, France, 75018 | |
Contact: Laurent ABRAMOWITZ, MD +33(0)1 40 25 80 80 laurent.abramowitz@bch.aphp.fr | |
Hopital BICHAT | Recruiting |
PARIS, France, 75018 | |
Contact: Laurent ABRAMOWITZ, MD |
Principal Investigator: | Laurent ABRAMOWITZ, MD | Assistance Publique - Hôpitaux de Paris |
Responsible Party: | Department Clinical Research ( Myriem CARRIER ) |
Study ID Numbers: | P060246 |
Study First Received: | February 28, 2008 |
Last Updated: | March 26, 2008 |
ClinicalTrials.gov Identifier: | NCT00632567 History of Changes |
Health Authority: | France: National Consultative Ethics Committee for Health and Life Sciences; France: French Data Protection Authority |
Anal incontinence First delivery was traumatic No anal incontinence |
Signs and Symptoms Fecal Incontinence Digestive System Diseases Urologic Diseases Urination Disorders |
Gastrointestinal Diseases Neoplasm Metastasis Urinary Incontinence Intestinal Diseases Rectal Diseases |
Signs and Symptoms Urological Manifestations Fecal Incontinence Digestive System Diseases Urologic Diseases |
Urination Disorders Gastrointestinal Diseases Urinary Incontinence Intestinal Diseases Rectal Diseases |