Obstetric and Proctology Support of Patients With Perineums Suits

Sponsor
Groupe Hospitalier Paris Saint Joseph (Other)
Overall Status
Active, not recruiting
CT.gov ID
NCT02823717
Collaborator
(none)
186
1
95
2

Study Details

Study Description

Brief Summary

Perineal tear grade III and IV are relatively common (1-10% of deliveries depending on the series), and are a source of potentially serious complications, even long time after delivery (especially disorders of anal continence, psychological trauma). If a number of risk factors are well described, the support arrangements at the time of delivery and the characteristics of the review Proctological remote delivery and its relationship to the clinical status of patients is little known and rarely studied.

In maternity wards of the hospital Saint Joseph Paris and Cochin-Port Royal group, patients with a diagnosis of severe perineal tear was made are taken following load with common rules, both for the immediate repair for the remote monitoring. Patients of both sites are indeed encouraged to consult in proctology consultation in Saint Joseph 4-6 months of birth.

The same support on both sites allows to consider the creation of a relatively homogeneous cohort in terms of support and consider an important recruitment. Moreover, the geographical proximity of the inclusions sites (maternity) with proctology service is likely to limit the risk of lost sight of.

Condition or Disease Intervention/Treatment Phase

    Detailed Description

    Main objective / secondary:

    Describe exactly the operational management of severe perineal tear (grade III and IV), their context and the factors associated with them occurring, the results of clinical and paraclinical proctology examination carried away from the birth, and study their relationship with the clinical status of patients at 6 months, 1, 2 and 3 years of confinement.

    Methodology :

    Type prospective, multicentre, non-interventional Study duration: 6 years

    Study Design

    Study Type:
    Observational [Patient Registry]
    Actual Enrollment :
    186 participants
    Observational Model:
    Cohort
    Time Perspective:
    Prospective
    Official Title:
    Obstetric and Proctology Support of Patients With Perineums Suits. Prospective Cohort
    Actual Study Start Date :
    Jan 31, 2015
    Actual Primary Completion Date :
    Jan 31, 2018
    Anticipated Study Completion Date :
    Dec 31, 2022

    Outcome Measures

    Primary Outcome Measures

    1. Assessment of change of Bristol Score [6 months, 1, 2 and 3 years of birth]

      The Bristol stool scale is a diagnostic medical tool designed to classify the form of human faeces into seven categories. It is used in both clinical and experimental fields.

    2. Assessment of change of anal incontinence score [6 months, 1, 2 and 3 years of birth]

      The severity of fecal incontinence can be assessed by a scoring system which takes into account the type and frequency of incontinence as well as the extent to which it alters the patient's life. This can also be used to monitor the patient over time, especially after interventions.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    Female
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:
    • All patients over 18 years

    • Affiliated to the national system of social security,

    • Giving birth during the period of inclusion of the St. Joseph site or Port Royal for whom the diagnosis of severe perineal tear was done.

    Exclusion Criteria:
    • None

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Groupe Hospitalier Paris Saint Joseph Paris Ile-de-Francfe France 75014

    Sponsors and Collaborators

    • Groupe Hospitalier Paris Saint Joseph

    Investigators

    • Principal Investigator: AZRIA Elie, MD, Groupe Hospitalier Paris Saint Joseph

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Groupe Hospitalier Paris Saint Joseph
    ClinicalTrials.gov Identifier:
    NCT02823717
    Other Study ID Numbers:
    • PERINEE COMPLET
    First Posted:
    Jul 6, 2016
    Last Update Posted:
    Jun 30, 2022
    Last Verified:
    Jun 1, 2022

    Study Results

    No Results Posted as of Jun 30, 2022