Outcome of TAMIS Mucosal Resection in Patients With ODS

Medical University of Vienna

Status: Completed

Conditions: Constipation, Impaction, and Bowel Obstruction; TAMIS Mucosectomy; Obstructed Defecation Syndrome

Treatments: Procedure: TAMIS mucosectomy

Study type: Observational

Funder types: Other

Identifiers

NCT06522399

1415/2022

Details and patient eligibility

About

Patients, aged 18 - 90 years, undergoing TAMIS mucosectomy at the Department of General Surgery at the Medical University of Vienna are enrolled into our study.

Primary endpoint is the outcome (improvement of ODS symptoms), defined by ODS score.

Full description

Various surgical approaches for the treatment of obstructed defecation syndrome (ODS) commonly associated with rectocele and rectal intussusception have been investigated in the literature. Methods such as stapled transanal resection of the rectum (STARR) and ventral prosthesis rectopexy (VPR) show promising results at least in the short term. In the long-term, however, the results do not seem convincing. Schiano di Visconte et al. report a recurrence of ODS symptoms in 40 percent of the patients, treated with stapled transanal rectal resection in a 10-year follow up. The clinical outcome of surgical treatment of ODS using transanal minimally invasive surgery (TAMIS) in the sense of a mucosal resection without stapling technique has not yet been investigated. This project is designed to show the short-term outcome of non-stapled mucosal resection through TAMIS.

Enrollment: 11 patients

Sex: All

Ages: 18 to 90 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Need of minimal invasive mucosal resection due to obstructed defecation syndrome after several unsuccessful conservative treatments over a period of more than 6 months with presence of an organic cause (Symptomatic intussusception with or without rectocele) in medical examinations (defecography, endoluminal ultrasound, endoanal manometry)
• Age: 18-90 years
• Ability and willingness to understand and comply with planned interventions during the study.
• Voluntarily signed informed consent after a full explanation of the study to the participant.

Exclusion criteria

• Any physical or mental disorder 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.

Trial design

11 participants in 1 patient group

patients with obstructed defecation who undergo TAMIS mucosectomy

Description:

patients with obstructed defecation and rectocele or intussuception

Treatment:

Procedure: TAMIS mucosectomy