Outcome of TAMIS Mucosal Resection in Patients With ODS

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

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.

Study Overview

• Status: Completed
• Conditions: Constipation, Impaction, and Bowel Obstruction; Obstructed Defecation Syndrome; TAMIS Mucosectomy
• Intervention / Treatment: Procedure: TAMIS mucosectomy

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 Type: Observational
• Enrollment (Actual): 11

Contacts and Locations

Study Locations

• Austria
  • Vienna, Austria, 1090
    • Medical University of Vienna

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Patients will be enrolled who ungergo minimally 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)

Description

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 Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
patients with obstructed defecation who undergo TAMIS mucosectomy; patients with obstructed defecation and rectocele or intussuception	Procedure: TAMIS mucosectomy; internal Delorme's procedure using TAMIS

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
functional outcome assessment	functional outcome defined by ODS score	6 months

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Medical University of Vienna
• Investigators: Study Chair: Stefan Riss, MD, Medical University of Vienna, Head of Pelvic Floor surgery

Study record dates

Study Major Dates

• Study Start (Actual): August 1, 2021
• Primary Completion (Actual): October 1, 2023
• Study Completion (Actual): October 1, 2023

Study Registration Dates

• First Submitted: July 22, 2024
• First Submitted That Met QC Criteria: July 22, 2024
• First Posted (Actual): July 26, 2024

Study Record Updates

• Last Update Posted (Actual): July 26, 2024
• Last Update Submitted That Met QC Criteria: July 22, 2024
• Last Verified: July 1, 2024

More Information

Terms related to this study

• Keywords: obstructed defecation syndrome; TAMIS mucosectomy
• Additional Relevant MeSH Terms: Digestive System Diseases; Pathologic Processes; Disease; Signs and Symptoms, Digestive; Gastrointestinal Diseases; Intestinal Diseases; Syndrome; Constipation; Intestinal Obstruction
• Other Study ID Numbers: 1415/2022

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: IPD can be shared just in anonymised form in case of an ethical agreement with other researchers.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No