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

Completed
Conditions
Rectal Cancer
Interventions
Procedure: Rectal washout
Registration Number
NCT04730102
Lead Sponsor
Slagelse Hospital
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.

Recruitment & Eligibility

Status
COMPLETED
Sex
All
Target Recruitment
21
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

Study Type
OBSERVATIONAL
Study Design
Not specified
Arm && Interventions
GroupInterventionDescription
Patients undergoing rectal washout in transanal mesorectal excisionRectal washoutPatients undergoing rectal washout in transanal mesorectal excision for rectal cancer.
Primary Outcome Measures
NameTimeMethod
Existence of intraluminal malignant cells in fluid samples from rectal washoutIntraoperatively

Positive/negative cytology

Secondary Outcome Measures
NameTimeMethod
Fluid volume needed to perform rectal washout during transanal total mesorectal excision to eliminate intraluminal malignant cellsIntraoperatively

Positive/negative cytology

Trial Locations

Locations (1)

Slagelse Hospital

🇩🇰

Slagelse, Zealand, Denmark

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