Outcome of TAMIS Mucosal Resection in Patients With ODS

Medical University of Vienna11 enrolled

Overview

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.

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 Type

OBSERVATIONAL

Enrollment

Conditions

Constipation, Impaction, and Bowel Obstruction TAMIS Mucosectomy Obstructed Defecation Syndrome

Interventions

TAMIS mucosectomyPROCEDURE

internal Delorme's procedure using TAMIS

Eligibility

Sex: ALLMin age: 18 YearsMax age: 90 Years

Medical Language ↔ Plain English

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.

Locations (1)

Medical University of Vienna

Vienna, Austria

Outcomes

Primary Outcomes

functional outcome assessment

functional outcome defined by ODS score

Time frame: 6 months

Secondary Outcomes

fecal incontinence assessment

fecal incontinence improvement or worsening measured by using the VAIZEY Score

Time frame: 6 months

Quality of life assessment

Health-related quality of life after TAMIS in ODS patients, defined by Quality of Life Score (SF12).

Time frame: 6 months

Data from ClinicalTrials.gov

This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.