Obstetric and Proctology Support of Patients With Perineums Suits

Obstetric and Proctology Support of Patients With Perineums Suits. Prospective Cohort

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Obstetric Complications; Muscle Tear

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 Type: Observational
• Enrollment (Actual): 186

Contacts and Locations

Study Locations

• France
  • Ile-de-Francfe
    • Paris, Ile-de-Francfe, France, 75014
      • Groupe hospitalier Paris saint Joseph

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

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.

Description

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

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Assessment of change of Bristol Score	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.	6 months, 1, 2 and 3 years of birth
Assessment of change of anal incontinence score	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.	6 months, 1, 2 and 3 years of birth

Collaborators and Investigators

• Sponsor: Groupe Hospitalier Paris Saint Joseph
• Investigators: Principal Investigator: AZRIA Elie, MD, Groupe hospitalier Paris saint Joseph

Study record dates

Study Major Dates

• Study Start (Actual): January 31, 2015
• Primary Completion (Actual): January 31, 2018
• Study Completion (Anticipated): December 31, 2023

Study Registration Dates

• First Submitted: June 29, 2016
• First Submitted That Met QC Criteria: July 5, 2016
• First Posted (Estimate): July 6, 2016

Study Record Updates

• Last Update Posted (Actual): April 27, 2023
• Last Update Submitted That Met QC Criteria: April 26, 2023
• Last Verified: April 1, 2023

More Information

Terms related to this study

• Other Study ID Numbers: PERINEE COMPLET