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

NCT ID: NCT05992948

Last Updated: 2023-08-15

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

UNKNOWN

Total Enrollment

90 participants

Study Classification

OBSERVATIONAL

Study Start Date

2020-01-01

Study Completion Date

2025-01-01

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Transanal Stapled Anastomosis

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

CASE_ONLY

Study Time Perspective

PROSPECTIVE

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Transanal stapling device

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

Intervention Type DEVICE

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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
Minimum Eligible Age

18 Years

Maximum Eligible Age

90 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Medical University of Vienna

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Dr. Christopher Dawoud

Principal Investigator; MD

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Medical University of Vienna

Vienna, , Austria

Site Status RECRUITING

Countries

Review the countries where the study has at least one active or historical site.

Austria

Central Contacts

Reach out to these primary contacts for questions about participation or study logistics.

Christopher Dawoud, MD

Role: CONTACT

0043 1 40400 56220

Facility Contacts

Find local site contact details for specific facilities participating in the trial.

Christopher Dawoud, MD

Role: primary

+43 660 280 48 39

Stefan Riss, Prof.MD

Role: backup

+43 1 40400 56210

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

2192/2019

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.