Outcome of TAMIS Mucosal Resection in Patients With ODS | NCT06522399

Studies
Outcome of TAMIS Mucosal Resection in Patients With ODS

NCT06522399

Sponsor

Medical University of Vienna

Status

Completed

Last Update Posted

Jul 26, 2024Actual

Enrollment

11Actual

Phase

Not provided

Conditions

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

Interventions

TAMIS mucosectomy

Countries

Austria

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jul 2024

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Aug 1, 2021Actual

Primary Completion Date

Oct 1, 2023Actual

Completion Date

Oct 1, 2023Actual

First Submitted Date

Jul 22, 2024

First Submission Date that Met QC Criteria

Jul 22, 2024

First Posted Date

Jul 26, 2024Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jul 22, 2024

Last Update Posted Date

Jul 26, 2024Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

FDAAA801 Violation

Not provided

Description Module

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.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

11Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
patients with obstructed defecation who undergo TAMIS mucosectomy		patients with obstructed defecation and rectocele or intussuception	Procedure: TAMIS mucosectomy

Interventions

Name	Type	Description	Arm Group Labels	Other Names
TAMIS mucosectomy	Procedure	internal Delorme's procedure using TAMIS	patients with obstructed defecation who undergo TAMIS mucosectomy

Outcomes Module

Primary Outcomes

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

Secondary Outcomes

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).

Other Outcomes

Not provided

Eligibility Module

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.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

90 Years

Standard Ages

AdultOlder Adult

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)

Sampling Method

Non-Probability Sample

Name	Affiliation	Role
Stefan Riss, MD	Medical University of Vienna, Head of Pelvic Floor surgery	Study Chair

Facility	Status	City	State	ZIP	Country	Contacts
Medical University of Vienna		Vienna		1090	Austria

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
39984789	Derived	Widmann KM, Dawoud C, Gidl D, Riss S. Transanal minimally invasive (TAMIS) mucosal resection with muscular plication for patients with obstructed defecation syndrome-A prospective pilot study. Tech Coloproctol. 2025 Feb 21;29(1):71. doi: 10.1007/s10151-024-03101-3.

ID	Term
D003248	Constipation
D007415	Intestinal Obstruction

ID	Term
D012817	Signs and Symptoms, Digestive
D012816	Signs and Symptoms
D013568	Pathological Conditions, Signs and Symptoms
D007410	Intestinal Diseases