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

• Sponsor: Medical University of Vienna (Other)
• Overall Status: Recruiting
• CT.gov ID: NCT05992948
• Collaborator: (none)
• Enrollment: 90
• Location: 1
• Anticipated Duration (Months): 60
• Patients Per Site Per Month: 1.5

Study Details

Study Description

Brief Summary

Investigation of the sphincter muscles after low anterior or anterior rectum resection, and sigma resection operation by endoluminal ultrasound and manometrical examination.

Condition or Disease	Intervention/Treatment	Phase
Transanal Stapled Anastomosis	Device: Transanal stapling device

Study Design

• Study Type: Observational
• Anticipated Enrollment: 90 participants
• Observational Model: Case-Only
• Time Perspective: Prospective
• Official Title: Endosonograpic Monitoring of Injury to the Anal Sphincter After Transanal Stapled Anastomosis
• Actual Study Start Date: Jan 1, 2020
• Anticipated Primary Completion Date: Jan 1, 2025
• Anticipated Study Completion Date: Jan 1, 2025

Outcome Measures

Primary Outcome Measures

1. EAUS [3 months postoperative]

   Change in thickness of the anal sphincter muscles in mm from baseline to 3 months

Secondary Outcome Measures

1. Endoanal manometry [3 months postoperative]

   Change in Anal pressure in mmHg from baseline to 3 months

2. EAUS2 [3 months postoperative]

   Change in the defect grade of anal sphincter muscles from baseline to 3 months

3. EAUS2-2 [12 months postoperative]

   Change in thickness of the anal sphincter muscles in mm from baseline to 12 months

4. EAUS2-2 [12 months postoperative]

   Change in the defect grade of anal sphincter muscles from baseline to 12 months

5. Endoanal manometry2 [12 months postoperative]

   Change in Anal pressure in mmHg from baseline to 12 months

Other Outcome Measures

1. LARS Score [3 months postoperative]

   Change in LARS Score from baseline to 3 months

2. LARS Score2 [12 months postoperative]

   Change in LARS Score from baseline to 12 months

3. LARS2 [12 months postoperative]

   Change in LARS Score from baseline to 12 months

4. Vaizey Score [3 months postoperative]

   Change in Vaizey Score from baseline to 3 months

5. Vaizey Score2 [12 months postoperative]

   Change in Vaizey Score from baseline to 12 months

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 90 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Medical University of Vienna	Vienna		Austria	1090

Sponsors and Collaborators

• Medical University of Vienna

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Dr. Christopher Dawoud, Principal Investigator; MD, Medical University of Vienna
• ClinicalTrials.gov Identifier: NCT05992948
• Other Study ID Numbers: 2192/2019
• First Posted: Aug 15, 2023
• Last Update Posted: Aug 15, 2023
• Last Verified: Aug 1, 2023

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Study Results

No Results Posted as of Aug 15, 2023