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Traumatic Anal Sphincteric Injury Immediate vs Delayed Repair

Sponsor
Assiut University (Other)
Overall Status
Recruiting
CT.gov ID
NCT05234931
Collaborator
(none)
30
Enrollment
1
Location
30.9
Anticipated Duration (Months)
1
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

comparison between immediate and delayed repair regarding the need for another technique ,pain score or repositioning and need for repair. We aim to evaluate the effects of immediate and delayed repair regarding the morbidity and mortalit

  • Objective 1: to assess the operative time and surgical field of both choices.

  • Objective 2: to estimate post-operative pain using pain score, to measure hospital stay and to assess short -term post-operative complications

Condition or Disease Intervention/Treatment Phase

    Detailed Description

    Many different secondary procedures have been described in an attempt to restore continence. These may be classified into indirect methods, where the divided sphincter is left unrepaired, and direct methods to repair the sphincter itself. Indirect techniques include construction of circum anal slings of striated muscle or fascia external sphincter reefing procedures" and the use of striated muscle grafts. Direct methods involve identification, mobilization, and suture of the ends of the divided sphincter. Thearliest 'attempts employed an end-to-end

    Study Design

    Study Type:
    Observational
    Anticipated Enrollment :
    30 participants
    Observational Model:
    Other
    Time Perspective:
    Cross-Sectional
    Official Title:
    Traumatic Anal Sphincteric Injury Immediate vs Delayed Repair
    Actual Study Start Date :
    Jan 1, 2021
    Anticipated Primary Completion Date :
    Apr 1, 2023
    Anticipated Study Completion Date :
    Aug 1, 2023

    Outcome Measures

    Primary Outcome Measures

    1. comparison between immediate and delayed repair [Baseline]

      Regarding the need for another technique ,pain score or repositioning and need for repair. We aim to evaluate the effects of immediate and delayed repair regarding the morbidity and mortalit Objective 1: to assess the operative time and surgical field of both choices. Objective 2: to estimate post-operative pain using pain score, to measure hospital stay and to assess short -term post-operative complications

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 75 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:

    1. both sex

      • Traumatic Patients Who Presented by anal Sphincteric Injury

    3. accept to participate in the study

    Exclusion Criteria:

    1. Patient who arrest immediately when arrived trauma unit

    2. Obstetric Patients Who Presented by anal Sphincteric Injury

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Assiut university Assiut Egypt

    Sponsors and Collaborators

    • Assiut University

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Ahmed Youssef Mohamed Ali, DOCTOR, Assiut University
    ClinicalTrials.gov Identifier:
    NCT05234931
    Other Study ID Numbers:
    • anal sphincteric injury
    First Posted:
    Feb 10, 2022
    Last Update Posted:
    Feb 10, 2022
    Last Verified:
    Feb 1, 2022
    Additional relevant MeSH terms:
    Wounds and Injuries

    Study Results

    No Results Posted as of Feb 10, 2022