Clinical trial NCT06522399: Outcome of TAMIS Mucosal Resection in Patients With ODS
Official title: Outcome of Transanal Minimally Invasive (TAMIS) Mucosal Resection in Patients With Obstructed Defecation Syndrome - a Pilot Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Constipation, Impaction, and Bowel Obstruction
TAMIS Mucosectomy
Obstructed Defecation Syndrome
Keywords: obstructed defecation syndrome
TAMIS mucosectomy
Lead sponsor: Medical University of Vienna
Sponsor class: OTHER
First posted: 2024-07-26
Enrollment: 11
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: RETROSPECTIVE
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)

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.

Eligibility criteria: 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.

Primary outcomes:
measure: functional outcome assessment
timeFrame: 6 months
Secondary outcomes:
measure: fecal incontinence assessment
timeFrame: 6 months
measure: Quality of life assessment
timeFrame: 6 months
Other outcomes:
Locations:
city: Vienna
country: Austria
facility: Medical University of Vienna
Study officials:
affiliation: Medical University of Vienna, Head of Pelvic Floor surgery
name: Stefan Riss, MD
role: STUDY_CHAIR
References: