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

Medical University of Vienna90 enrolled

Overview

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

Study Type

OBSERVATIONAL

Enrollment

Conditions

Transanal Stapled Anastomosis

Interventions

Transanal stapling deviceDEVICE

Transanal stapling device used in low anterior- or anterior rectum resection, sigma resection, left hemicolectomy and intestinal reconstruction operations

Eligibility

Sex: ALLMin age: 18 YearsMax age: 90 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

Locations (1)

Medical University of Vienna

Vienna, Austria

RECRUITING

Outcomes

Primary Outcomes

EAUS

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

Time frame: 3 months postoperative

Secondary Outcomes

Endoanal manometry

Change in Anal pressure in mmHg from baseline to 3 months

Time frame: 3 months postoperative

EAUS2

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

Time frame: 3 months postoperative

EAUS2-2

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

Time frame: 12 months postoperative

EAUS2-2

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

Time frame: 12 months postoperative

Endoanal manometry2

Change in Anal pressure in mmHg from baseline to 12 months

Time frame: 12 months postoperative

Central Contacts

Christopher Dawoud, MD

CONTACT

0043 1 40400 56220 christopher.dawoud@muv.ac.at

Data from ClinicalTrials.gov

This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.