Outcome of TAMIS Mucosal Resection in Patients With ODS

NCT06522399 | Completed

• 1 other identifier: 1415/2022
• Study Type: observational
• Target: 11
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Keywords

obstructed defecation syndrome; TAMIS mucosectomy

Outcome Measures

Primary Outcomes (1)

• functional outcome assessment

  functional outcome defined by ODS score

  6 months

Secondary Outcomes (2)

• fecal incontinence assessment

  6 months

• Quality of life assessment

  6 months

Study Arms (1)

patients with obstructed defecation who undergo TAMIS mucosectomy

patients with obstructed defecation and rectocele or intussuception

Procedure: TAMIS mucosectomy

Interventions

TAMIS mucosectomy PROCEDURE

internal Delorme's procedure using TAMIS

patients with obstructed defecation who undergo TAMIS mucosectomy

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Medical University of Vienna: lead

Study Sites (1)

Medical University of Vienna

Vienna, 1090, Austria

Location

MeSH Terms

Conditions

Constipation; Intestinal Obstruction

Condition Hierarchy (Ancestors)

Signs and Symptoms, Digestive; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Intestinal Diseases; Gastrointestinal Diseases; Digestive System Diseases

Study Officials

• Stefan Riss, MD

  Medical University of Vienna, Head of Pelvic Floor surgery

  STUDY CHAIR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Dr. Christopher Dawoud

Study Record Dates

• First Submitted: July 22, 2024
• First Posted: July 26, 2024
• Study Start: August 1, 2021
• Primary Completion: October 1, 2023
• Study Completion: October 1, 2023
• Last Updated: July 26, 2024

Record last verified: 2024-07

Data Sharing

• IPD Sharing: Will not share

Locations

AU (1)