Rectal Washout in Transanal Total Mesorectal Excision and Presence of Intraluminal Malignant Cells

NCT ID: NCT04730102

Last Updated: 2021-02-10

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Total Enrollment

21 participants

Study Classification

OBSERVATIONAL

Study Start Date

2020-02-13

Study Completion Date

2021-02-09

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

The study aims to assess the existence of intraluminal malignant cells and the appropriate fluid volume needed to perform rectal washout during transanal total mesorectal excision (taTME) for rectal cancer.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Twenty patients undergoing taTME for rectal cancer is included. Following the closure of the rectal lumen by a purse string suture, rectal washout is performed with a total of 500 ml sterile water. Fluid samples are collected after every 100 ml by instilling 50 ml of saline after each washout. A sixth sample is collected from the presacral cavity. Each sample is cytologically examined by a pathologist and labelled either malignant or non-malignant.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Rectal Cancer

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

COHORT

Study Time Perspective

CROSS_SECTIONAL

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Patients undergoing rectal washout in transanal mesorectal excision

Patients undergoing rectal washout in transanal mesorectal excision for rectal cancer.

Rectal washout

Intervention Type PROCEDURE

Rectal washout is performed intraoperatively before transection and means irrigation of the rectum following the closure of the rectal lumen below the tumour with a purse string suture. Rectal washout is performed with a total of 500 ml sterile water. Fluid samples are collected after every 100 ml by instilling 50 ml of saline after each washout. A sixth sample is collected from the presacral cavity.

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Rectal washout

Rectal washout is performed intraoperatively before transection and means irrigation of the rectum following the closure of the rectal lumen below the tumour with a purse string suture. Rectal washout is performed with a total of 500 ml sterile water. Fluid samples are collected after every 100 ml by instilling 50 ml of saline after each washout. A sixth sample is collected from the presacral cavity.

Intervention Type PROCEDURE

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* Surgery at Slagelse Hospital for rectal cancer with transanal mesorectal excision
* Consent to participate in the study

Exclusion Criteria

* No consent to participate
* No surgery
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Skane University Hospital

OTHER

Sponsor Role collaborator

Lund University

OTHER

Sponsor Role collaborator

Slagelse Hospital

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Pamela Buchwald

Role: PRINCIPAL_INVESTIGATOR

Skåne University Hospital, Malmö, Region Skåne, Sweden

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Slagelse Hospital

Slagelse, Region Sjælland, Denmark

Site Status

Countries

Review the countries where the study has at least one active or historical site.

Denmark

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

2019-2567

Identifier Type: OTHER_GRANT

Identifier Source: secondary_id

ALF Region Skåne

Identifier Type: OTHER_GRANT

Identifier Source: secondary_id

SJ-817

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

Local Recurrence Due to Rectal Cancer in Sweden
NCT04404777 ACTIVE_NOT_RECRUITING