Endosonograpic Monitoring of Injury to the Anal Sphincter After Transanal Stapled Anastomosis
Recruiting
- Conditions
- Transanal Stapled Anastomosis
- Registration Number
- NCT05992948
- Lead Sponsor
- Medical University of Vienna
- Brief Summary
Investigation of the sphincter muscles after low anterior or anterior rectum resection, and sigma resection operation by endoluminal ultrasound and manometrical examination.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 90
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 & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method EAUS 3 months postoperative Change in thickness of the anal sphincter muscles in mm from baseline to 3 months
- Secondary Outcome Measures
Name Time Method Endoanal manometry 3 months postoperative Change in Anal pressure in mmHg from baseline to 3 months
EAUS2 3 months postoperative Change in the defect grade of anal sphincter muscles from baseline to 3 months
Endoanal manometry2 12 months postoperative Change in Anal pressure in mmHg from baseline to 12 months
EAUS2-2 12 months postoperative Change in the defect grade of anal sphincter muscles from baseline to 12 months
Trial Locations
- Locations (1)
Medical University of Vienna
🇦🇹Vienna, Austria