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

February 9, 2021 updated by: Slagelse Hospital
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

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.

Study Type

Observational

Enrollment (Actual)

21

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Denmark
    • Zealand
      • Slagelse, Zealand, Denmark, 4200
        • Slagelse Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Patients undergoing transanal mesorectal excision at Slagelse Hospital, Denmark

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Patients undergoing rectal washout in transanal mesorectal excision
Patients undergoing rectal washout in transanal mesorectal excision for rectal cancer.
Procedure: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Existence of intraluminal malignant cells in fluid samples from rectal washout
Time Frame: Intraoperatively
Positive/negative cytology
Intraoperatively

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Fluid volume needed to perform rectal washout during transanal total mesorectal excision to eliminate intraluminal malignant cells
Time Frame: Intraoperatively
Positive/negative cytology
Intraoperatively

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Slagelse Hospital

Collaborators

Lund University
Skane University Hospital

Investigators

  • Principal Investigator: Pamela Buchwald, Skåne University Hospital, Malmö, Region Skåne, Sweden

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 13, 2020

Primary Completion (Actual)

February 9, 2021

Study Completion (Actual)

February 9, 2021

Study Registration Dates

First Submitted

January 25, 2021

First Submitted That Met QC Criteria

January 25, 2021

First Posted (Actual)

January 29, 2021

Study Record Updates

Last Update Posted (Actual)

February 10, 2021

Last Update Submitted That Met QC Criteria

February 9, 2021

Last Verified

February 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SJ-817
  • 2019-2567 (Other Grant/Funding Number: Stig & Ragna Gorthons Foundation)
  • ALF Region Skåne (Other Grant/Funding Number: Governmental funding of clinical research within the National Health Services)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Rectal Cancer

Clinical Trials on Rectal washout

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Belgium

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe