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

Primary Purpose

Fecal Incontinence

Status
Completed
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
caesarean section
vaginal delivery
Sponsored by
Assistance Publique - Hôpitaux de Paris
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Fecal Incontinence focused on measuring Anal incontinence, First delivery was traumatic, No anal incontinence

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)FemaleDoes not accept healthy volunteers

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

Sites / Locations

  • Hopital BICHAT

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

1

2

Arm Description

caesarean section

vaginal delivery

Outcomes

Primary Outcome Measures

The primary endpoint is comparison of median incontinence score of VAIZEY in the two arms after 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

Full Information

First Posted
February 28, 2008
Last Updated
December 14, 2016
Sponsor
Assistance Publique - Hôpitaux de Paris
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1. Study Identification

Unique Protocol Identification Number
NCT00632567
Brief Title
EPIC :Anal Incontinence After Delivery. Secondary Prevention With Caesarean Section.
Acronym
EPIC
Official Title
Anal Incontinence After Delivery. Secondary Prevention With Caesarean Section.
Study Type
Interventional

2. Study Status

Record Verification Date
December 2016
Overall Recruitment Status
Completed
Study Start Date
March 2008 (undefined)
Primary Completion Date
March 2016 (Actual)
Study Completion Date
April 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Assistance Publique - Hôpitaux de Paris

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Fecal Incontinence
Keywords
Anal incontinence, First delivery was traumatic, No anal incontinence

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
554 (Actual)

8. Arms, Groups, and Interventions

Arm Title
1
Arm Type
Experimental
Arm Description
caesarean section
Arm Title
2
Arm Type
Active Comparator
Arm Description
vaginal delivery
Intervention Type
Procedure
Intervention Name(s)
caesarean section
Intervention Description
caesarean section for second delivery if the first had to be traumatic after forceps with anal sphincter rupture diagnosed with anal endosonography.
Intervention Type
Procedure
Intervention Name(s)
vaginal delivery
Intervention Description
vaginal delivery for second delivery if the first had to be traumatic after forceps with anal sphincter rupture diagnosed with anal endosonography.
Primary Outcome Measure Information:
Title
The primary endpoint is comparison of median incontinence score of VAIZEY in the two arms after 6 months.
Time Frame
6 months
Secondary Outcome Measure Information:
Title
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

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Laurent ABRAMOWITZ, MD
Organizational Affiliation
Assistance Publique - Hôpitaux de Paris
Official's Role
Principal Investigator
Facility Information:
Facility Name
Hopital BICHAT
City
Paris
ZIP/Postal Code
75018
Country
France

12. IPD Sharing Statement

Plan to Share IPD
Undecided

Learn more about this trial

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

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