Obstetric and Proctology Support of Patients With Perineums Suits

NCT02823717 | Unknown DMC

• 1 other identifier: PERINEE COMPLET
• Study Type: observational
• Target: 186
• Locations: 1 country
• Sites: 1

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.

Conditions

Obstetric Complications; Muscle Tear

Outcome Measures

Primary Outcomes (2)

• 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

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• All patients over 18 years
• Affiliated to the national system of social security,

You may not qualify if:

• None

Sponsors & Collaborators

• Fondation Hôpital Saint-Joseph: lead

Study Sites (1)

Groupe Hospitalier Paris Saint Joseph

Paris, Ile-de-Francfe, 75014, France

Location

Study Officials

• AZRIA Elie, MD

  Fondation Hôpital Saint-Joseph

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 3 Years
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 29, 2016
• First Posted: July 6, 2016
• Study Start: January 31, 2015
• Primary Completion: January 31, 2018
• Study Completion: December 31, 2023
• Last Updated: April 27, 2023

Record last verified: 2023-04

Locations

FR (1)