Outcome of TAMIS Mucosal Resection in Patients With ODS

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

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Recruitment Status

COMPLETED

Total Enrollment

11 participants

Study Classification

OBSERVATIONAL

Study Start Date

2021-08-01

Study Completion Date

2023-10-01

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

RETROSPECTIVE

Study Groups

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patients with obstructed defecation who undergo TAMIS mucosectomy

patients with obstructed defecation and rectocele or intussuception

TAMIS mucosectomy

Intervention Type PROCEDURE

internal Delorme's procedure using TAMIS

Interventions

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TAMIS mucosectomy

internal Delorme's procedure using TAMIS

Intervention Type PROCEDURE

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

90 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No