Endosonograpic Monitoring of Injury to the Anal Sphincter After Transanal Stapled Anastomosis

August 7, 2023 updated by: Dr. Christopher Dawoud, Medical University of Vienna
Investigation of the sphincter muscles after low anterior or anterior rectum resection, and sigma resection operation by endoluminal ultrasound and manometrical examination.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Estimated)

90

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 Locations

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

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Sampling Method

Non-Probability Sample

Study Population

Patients requiring transanal stapled anastomosis due to various reasons will be enrolled in this study.

Description

Inclusion Criteria:

Age 18 - 90 years, undergoing transanal stapled anastomosis at the Department of General Surgery, Medical University of Vienna

  • Ability and willingness to understand and comply with study interventions and restrictions.
  • Voluntarily signed informed consent after full explanation of the study to the participant.

Exclusion Criteria:

  • Any physical or mental disorder, which could interfere with the participant's safety during the clinical trial or with the study objectives
  • Inability to communicate well with the investigator due to language problems or reduced mental development
  • Inability or unwillingness to give written informed consent

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
EAUS
Time Frame: 3 months postoperative
Change in thickness of the anal sphincter muscles in mm from baseline to 3 months
3 months postoperative

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Endoanal manometry
Time Frame: 3 months postoperative
Change in Anal pressure in mmHg from baseline to 3 months
3 months postoperative
EAUS2
Time Frame: 3 months postoperative
Change in the defect grade of anal sphincter muscles from baseline to 3 months
3 months postoperative
EAUS2-2
Time Frame: 12 months postoperative
Change in thickness of the anal sphincter muscles in mm from baseline to 12 months
12 months postoperative
EAUS2-2
Time Frame: 12 months postoperative
Change in the defect grade of anal sphincter muscles from baseline to 12 months
12 months postoperative
Endoanal manometry2
Time Frame: 12 months postoperative
Change in Anal pressure in mmHg from baseline to 12 months
12 months postoperative

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
LARS Score
Time Frame: 3 months postoperative
Change in LARS Score from baseline to 3 months
3 months postoperative
LARS Score2
Time Frame: 12 months postoperative
Change in LARS Score from baseline to 12 months
12 months postoperative
LARS2
Time Frame: 12 months postoperative
Change in LARS Score from baseline to 12 months
12 months postoperative
Vaizey Score
Time Frame: 3 months postoperative
Change in Vaizey Score from baseline to 3 months
3 months postoperative
Vaizey Score2
Time Frame: 12 months postoperative
Change in Vaizey Score from baseline to 12 months
12 months postoperative

Collaborators and Investigators

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

Sponsor

Medical University of Vienna

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, 2020

Primary Completion (Estimated)

January 1, 2025

Study Completion (Estimated)

January 1, 2025

Study Registration Dates

First Submitted

March 27, 2023

First Submitted That Met QC Criteria

August 7, 2023

First Posted (Actual)

August 15, 2023

Study Record Updates

Last Update Posted (Actual)

August 15, 2023

Last Update Submitted That Met QC Criteria

August 7, 2023

Last Verified

August 1, 2023

More Information

Terms related to this study

Other Study ID Numbers

  • 2192/2019

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

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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