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Clinical Trials/NCT05992948
NCT05992948
Recruiting
Not Applicable

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

Medical University of Vienna1 site in 1 country90 target enrollmentStarted: January 1, 2020Last updated:
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ConditionsTransanal Stapled Anastomosis

Overview

Phase
Not Applicable
Status
Recruiting
Enrollment
90
Locations
1
Primary Endpoint
EAUS
OverviewStudy DesignEligibility CriteriaOutcomesInvestigatorsSitesRecords & IdentifiersSimilar Trials

Overview

Brief Summary

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

Study Design

Study Type
Observational
Observational Model
Case Only
Time Perspective
Prospective

Eligibility Criteria

Ages
18 Years to 90 Years (Adult, Older Adult)
Sex
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

Outcomes

Primary Outcomes

EAUS

Time Frame: 3 months postoperative

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

Secondary Outcomes

  • Endoanal manometry(3 months postoperative)
  • EAUS2(3 months postoperative)
  • Endoanal manometry2(12 months postoperative)
  • EAUS2-2(12 months postoperative)

Investigators

Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Dr. Christopher Dawoud

Principal Investigator; MD

Medical University of Vienna

Study Sites (1)

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