Clinical Trials Directory

Trials / Completed

CompletedNCT04730102

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

Status
Completed
Phase
Study type
Observational
Enrollment
21 (actual)
Sponsor
Slagelse Hospital · Academic / Other
Sex
All
Age
18 Years
Healthy volunteers
Not accepted

Summary

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

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

Interventions

TypeNameDescription
PROCEDURERectal washoutRectal 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.

Timeline

Start date
2020-02-13
Primary completion
2021-02-09
Completion
2021-02-09
First posted
2021-01-29
Last updated
2021-02-10

Locations

1 site across 1 country: Denmark

Source: ClinicalTrials.gov record NCT04730102. Inclusion in this directory is not an endorsement.