Outcome of TAMIS Mucosal Resection in Patients With ODS

Completed

• Conditions: TAMIS Mucosectomy; Obstructed Defecation Syndrome; Constipation, Impaction, and Bowel Obstruction
• Interventions: Procedure: TAMIS mucosectomy

• Registration Number: NCT06522399
• Lead Sponsor: Medical University of Vienna

Brief Summary

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.

Detailed 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.

Study Timeline

• Study Start: 2021-08-01
• Primary Completion: 2023-10-01
• Study Completion: 2023-10-01
• Status Verified: 2024-07
• Study First Submitted: 2024-07-22
• Study First Submitted QC: 2024-07-22
• Last Update Submitted: 2024-07-22
• Study First Posted: 2024-07-26
• Last Update Posted: 2024-07-26

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 11

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
patients with obstructed defecation who undergo TAMIS mucosectomy	TAMIS mucosectomy	patients with obstructed defecation and rectocele or intussuception

Primary Outcome Measures

Name	Time	Method
functional outcome assessment	6 months	functional outcome defined by ODS score

Secondary Outcome Measures

Name	Time	Method
fecal incontinence assessment	6 months	fecal incontinence improvement or worsening measured by using the VAIZEY Score
Quality of life assessment	6 months	Health-related quality of life after TAMIS in ODS patients, defined by Quality of Life Score (SF12).

Trial Locations

Locations (1)

Medical University of Vienna; 🇦🇹 Vienna, Austria