EPIC :Anal Incontinence After Delivery. Secondary Prevention With Caesarean Section. (EPIC)
|ClinicalTrials.gov Identifier: NCT00632567|
Recruitment Status : Completed
First Posted : March 10, 2008
Last Update Posted : December 15, 2016
|Condition or disease||Intervention/treatment||Phase|
|Fecal Incontinence||Procedure: caesarean section Procedure: vaginal delivery||Not Applicable|
Anal incontinence is frequent and treatment is difficult. One of the most important reasons 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 caused break in the anal sphincter. One possibility to avoid anal incontinence is the caesarean section.
So, do the investigators 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 randomized controlled 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. In start of study, all women were included, for randomisation ("section cesarean prophylactic" versus "vaginal delivery") if an anal sphincter rupture is diagnosed with anal endosonography before second delivery. . Currently, in case of refusal randomisation, women are proposed to participate to the ancillary study (cohort study).
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. The investigators estimated, needing 123 women in each arm.
Hospital investigators are: BICHAT Claude Bernard (Pr LUTON), Armand Trousseau (Pr BENIFLA), Jean VERDIER (Pr CARBILLON), BEAUJON (Pr LUTON), Louis MOURIER (Pr MANDELBROT), Versailles (Dr PANEL). Inclusion will be for 6 years and 9 months. Women will be included during the last trimester and evaluation will be perform on 8 weeks, 6 and 12 month after delivery.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||554 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||Anal Incontinence After Delivery. Secondary Prevention With Caesarean Section.|
|Study Start Date :||March 2008|
|Actual Primary Completion Date :||March 2016|
|Actual Study Completion Date :||April 2016|
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.
Active Comparator: 2
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.
- The primary endpoint is comparison of median incontinence score of VAIZEY in the two arms after 6 months. [ Time Frame: 6 months ]
- Incontinence scores in the two arms after 6/8 weeks and 6 month, transitional anal incontinence after delivery urinary incontinence 6 and 12 month after the delivery, sexual score(IFSI)global morbidity between the two arms after anal endoscopy [ Time Frame: 6 month and 12 month ]
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00632567
|Paris, France, 75018|
|Principal Investigator:||Laurent ABRAMOWITZ, MD||Assistance Publique - Hôpitaux de Paris|