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OpenTrials
Completed

NCT Number: NCT06522399

Outcome of TAMIS Mucosal Resection in Patients With ODS

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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Key information

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

TAMIS mucosectomy

Procedure

internal Delorme's procedure using TAMIS

Primary outcomes

  1. functional outcome assessment

    Time frame: 6 months

    functional outcome defined by ODS score

Secondary outcomes

  1. fecal incontinence assessment

    Time frame: 6 months

    fecal incontinence improvement or worsening measured by using the VAIZEY Score

  2. Quality of life assessment

    Time frame: 6 months

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

Sponsors and collaborators

Lead sponsor

Medical University of Vienna

Other

Registry information

Official study title

Outcome of Transanal Minimally Invasive (TAMIS) Mucosal Resection in Patients With Obstructed Defecation Syndrome - a Pilot Study

Important dates

Study start
2021
Primary completion
2023
Study completion
2023
First posted
Jul 26, 2024
Registry last updated
Jul 26, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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