Endosonograpic Monitoring of Injury to the Anal Sphincter... | NCT05992948

Studies
Endosonograpic Monitoring of Injury to the Anal Sphincter After Transanal Stapled Anastomosis

NCT05992948

Sponsor

Medical University of Vienna

Status

Unknown status

Last Update Posted

Aug 15, 2023Actual

Enrollment

90Estimated

Phase

Not provided

Conditions

Transanal Stapled Anastomosis

Interventions

Transanal stapling device

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

Aug 2023

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jan 1, 2020Actual

Primary Completion Date

Jan 1, 2025Estimated

Completion Date

Jan 1, 2025Estimated

First Submitted Date

Mar 27, 2023

First Submission Date that Met QC Criteria

Aug 7, 2023

First Posted Date

Aug 15, 2023Actual

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

Aug 7, 2023

Last Update Posted Date

Aug 15, 2023Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Dr. Christopher Dawoud, Principal Investigator; MD, Medical University of ViennaPrincipal Investigator

Lead Sponsor

Medical University of ViennaOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Not provided

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

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

Investigation of the sphincter muscles after low anterior or anterior rectum resection, and sigma resection operation by endoluminal ultrasound and manometrical examination.

Detailed Description

Not provided

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

90Estimated

Arms/Interventions Module

Arm Groups

Not provided

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Transanal stapling device	Device	Transanal stapling device used in low anterior- or anterior rectum resection, sigma resection, left hemicolectomy and intestinal reconstruction operations

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
EAUS	Change in thickness of the anal sphincter muscles in mm from baseline to 3 months	3 months postoperative

Secondary Outcomes

Measure	Description	Time Frame
Endoanal manometry	Change in Anal pressure in mmHg from baseline to 3 months	3 months postoperative
EAUS2	Change in the defect grade of anal sphincter muscles from baseline to 3 months

Other Outcomes

Measure	Description	Time Frame
LARS Score	Change in LARS Score from baseline to 3 months	3 months postoperative
LARS Score2	Change in LARS Score from baseline to 12 months

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Age 18 - 90 years, undergoing transanal stapled anastomosis at the Department of General Surgery, Medical University of Vienna

Ability and willingness to understand and comply with study interventions and restrictions.
Voluntarily signed informed consent after full explanation of the study to the participant.

Exclusion Criteria:

Any physical or mental disorder, which 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

Yes

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 requiring transanal stapled anastomosis due to various reasons will be enrolled in this study.

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Christopher Dawoud, MD	Contact	0043 1 40400 56220		christopher.dawoud@muv.ac.at

Overall Officials

Not provided

Locations

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

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided