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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

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT06522399
Enrollment
11
Registered
2024-07-26
Start date
2021-08-01
Completion date
2023-10-01
Last updated
2024-07-26

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

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

Keywords

obstructed defecation syndrome, TAMIS mucosectomy

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.

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.

Interventions

PROCEDURETAMIS mucosectomy

internal Delorme's procedure using TAMIS

Sponsors

Medical University of Vienna
Lead SponsorOTHER

Study design

Observational model
CASE_ONLY
Time perspective
RETROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to 90 Years
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
functional outcome assessment6 monthsfunctional outcome defined by ODS score

Secondary

MeasureTime frameDescription
fecal incontinence assessment6 monthsfecal incontinence improvement or worsening measured by using the VAIZEY Score
Quality of life assessment6 monthsHealth-related quality of life after TAMIS in ODS patients, defined by Quality of Life Score (SF12).

Countries

Austria

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026