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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00632567
First Posted: March 10, 2008
Last Update Posted: December 15, 2016
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Assistance Publique - Hôpitaux de Paris
  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
Intervention Model: Parallel Assignment
Masking: None (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 ]

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 ]

Enrollment: 554
Study Start Date: March 2008
Study Completion Date: April 2016
Primary Completion Date: March 2016 (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.
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.

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 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.

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes 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
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): NCT00632567


Locations
France
Hopital BICHAT
Paris, France, 75018
Sponsors and Collaborators
Assistance Publique - Hôpitaux de Paris
Investigators
Principal Investigator: Laurent ABRAMOWITZ, MD Assistance Publique - Hôpitaux de Paris
  More Information

Responsible Party: Assistance Publique - Hôpitaux de Paris
ClinicalTrials.gov Identifier: NCT00632567     History of Changes
Other Study ID Numbers: P060246
First Submitted: February 28, 2008
First Posted: March 10, 2008
Last Update Posted: December 15, 2016
Last Verified: December 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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


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