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EPICc:Anal Incontinence After Delivery. Secondary Prevention With Caesarean Section.
This study is currently recruiting participants.
Verified by Assistance Publique - Hôpitaux de Paris, February 2008
First Received: February 28, 2008   Last Updated: March 26, 2008   History of Changes
Sponsored by: Assistance Publique - Hôpitaux de Paris
Information provided by: Assistance Publique - Hôpitaux de Paris
ClinicalTrials.gov Identifier: NCT00632567
  Purpose

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
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.

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: July 2011
Estimated Primary Completion Date: July 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
1: Experimental
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.
2: Active Comparator
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 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.

  Eligibility

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

Inclusion Criteria:

  • More than18 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 stade 4.
  • Indication of a scheduled caesarean section not for proctologic reason
  • Patient physically, mentally or legally incompetent to give informed consent
  Contacts and Locations
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: 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

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

Study placed in the following topic categories:
Signs and Symptoms
Fecal Incontinence
Digestive System Diseases
Urologic Diseases
Urination Disorders
Gastrointestinal Diseases
Neoplasm Metastasis
Urinary Incontinence
Intestinal Diseases
Rectal Diseases

Additional relevant MeSH terms:
Signs and Symptoms
Urological Manifestations
Fecal Incontinence
Digestive System Diseases
Urologic Diseases
Urination Disorders
Gastrointestinal Diseases
Urinary Incontinence
Intestinal Diseases
Rectal Diseases

ClinicalTrials.gov processed this record on September 10, 2009