EPIC :Anal Incontinence After Delivery. Secondary Prevention With Caesarean Section.

This study is currently recruiting participants. (see Contacts and Locations)
Verified December 2013 by Assistance Publique - Hôpitaux de Paris
Sponsor:
Information provided by (Responsible Party):
Assistance Publique - Hôpitaux de Paris
ClinicalTrials.gov Identifier:
NCT00632567
First received: February 28, 2008
Last updated: December 31, 2013
Last verified: December 2013
  Purpose

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.


Condition Intervention
Fecal Incontinence
Procedure: caesarean section
Procedure: vaginal delivery

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
Official Title: Anal Incontinence After Delivery. Secondary Prevention With Caesarean Section.

Resource links provided by NLM:


Further study details as provided by Assistance Publique - Hôpitaux de Paris:

Primary Outcome Measures:
  • The primary endpoint is comparison of median incontinence score of VAIZEY in the two arms after 6 months. [ Time Frame: 6 months ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • 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 ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 369
Study Start Date: March 2008
Estimated Study Completion Date: October 2014
Estimated Primary Completion Date: October 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
caesarean section
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.
Other Name: caesarean section
Active Comparator: 2
vaginal delivery
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.
Other Name: vaginal delivery

Detailed Description:

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 4 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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • More than 18 years old
  • Having health insurance
  • Second pregnancy
  • Inclusion in the third trimester
  • First delivery was traumatic
  • No anal incontinence
  • Accept to participate, sign the informed consent
  • Prior medical examination

Exclusion Criteria:

  • Monitoring impossible
  • Woman who have an anal operation
  • Caesarean section
  • First delivery with anal break stage 4
  • Indication of a scheduled caesarean section not for proctologic reason
  • Patient physically, mentally or legally incompetent to give informed consent
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00632567

Contacts
Contact: Laurent ABRAMOWITZ, MD +33(0)1 40 25 80 80 ext bip 2225 laurent.abramowitz@bch.aphp.fr

Locations
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         
Sponsors and Collaborators
Assistance Publique - Hôpitaux de Paris
Investigators
Principal Investigator: Laurent ABRAMOWITZ, MD Assistance Publique - Hôpitaux de Paris
  More Information

No publications provided

Responsible Party: Assistance Publique - Hôpitaux de Paris
ClinicalTrials.gov Identifier: NCT00632567     History of Changes
Other Study ID Numbers: P060246
Study First Received: February 28, 2008
Last Updated: December 31, 2013
Health Authority: France: National Consultative Ethics Committee for Health and Life Sciences
France: French Data Protection Authority

Keywords provided by Assistance Publique - Hôpitaux de Paris:
Anal incontinence
First delivery was traumatic
No anal incontinence

Additional relevant MeSH terms:
Fecal Incontinence
Rectal Diseases
Intestinal Diseases
Gastrointestinal Diseases
Digestive System Diseases

ClinicalTrials.gov processed this record on August 19, 2014