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NCT04730102 Clinical Trial

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

Rectal Cancer Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT04730102
Other study ID # SJ-817
Secondary ID 2019-2567ALF Reg
Status Completed
Phase
First received
Last updated
Start date February 13, 2020
Est. completion date February 9, 2021

Study information
Verified date February 2021
Source Slagelse Hospital
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.

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.

Recruitment information / eligibility
Status Completed
Enrollment 21
Est. completion date February 9, 2021
Est. primary completion date February 9, 2021
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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 Design

Related Conditions & MeSH terms

Intervention

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.

Locations
Country Name City State
Denmark Slagelse Hospital Slagelse Zealand

Sponsors (3)
Lead Sponsor Collaborator
Slagelse Hospital Lund University, Skane University Hospital

Country where clinical trial is conducted

Denmark, 

Outcome
Type Measure Description Time frame Safety issue
Primary Existence of intraluminal malignant cells in fluid samples from rectal washout Positive/negative cytology Intraoperatively
Secondary Fluid volume needed to perform rectal washout during transanal total mesorectal excision to eliminate intraluminal malignant cells Positive/negative cytology Intraoperatively
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