Traumatic Anal Sphincteric Injury Immediate vs Delayed Repair

February 9, 2022 updated by: Ahmed Youssef Mohamed Ali, Assiut University

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

Study Overview

Status

Recruiting

Conditions

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 Type

Observational

Enrollment (Anticipated)

30

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Egypt
      • Assiut, Egypt
        • Recruiting
        • Assiut University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

sample size was calculated using epidemiological information statistical package version7 Based on paramaters for cross sectional study

Description

Inclusion Criteria:

  1. both sex
  2. - 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
comparison between immediate and delayed repair
Time Frame: 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
Baseline

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Assiut University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 1, 2021

Primary Completion (Anticipated)

April 1, 2023

Study Completion (Anticipated)

August 1, 2023

Study Registration Dates

First Submitted

January 30, 2022

First Submitted That Met QC Criteria

February 9, 2022

First Posted (Actual)

February 10, 2022

Study Record Updates

Last Update Posted (Actual)

February 10, 2022

Last Update Submitted That Met QC Criteria

February 9, 2022

Last Verified

February 1, 2022

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • anal sphincteric injury

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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