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

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT04730102

Enrollment

Registered

2021-01-29

Start date

2020-02-13

Completion date

2021-02-09

Last updated

2021-02-10

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Rectal Cancer

Keywords

Rectal washout, transanal total mesorectal excision, rectal cancer

Brief 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.

Interventions

PROCEDURERectal 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.

Study design

Observational model

COHORT

Time perspective

CROSS_SECTIONAL

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

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

Secondary

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

Countries

Denmark

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026