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Completed

NCT Number: NCT04730102

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

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.

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Key information

Conditions

Rectal Cancer Colorectal Neoplasms Digestive System Diseases Digestive System Neoplasms Gastrointestinal Diseases Gastrointestinal Neoplasms Intestinal Diseases Intestinal Neoplasms Neoplasms Neoplasms by Site Rectal Diseases Rectal Neoplasms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Slagelse Hospital

Slagelse, Region Sjælland, 4200, Denmark

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Rectal washout

Procedure

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.

Primary outcomes

  1. Existence of intraluminal malignant cells in fluid samples from rectal washout

    Time frame: Intraoperatively

    Positive/negative cytology

Secondary outcomes

  1. Fluid volume needed to perform rectal washout during transanal total mesorectal excision to eliminate intraluminal malignant cells

    Time frame: Intraoperatively

    Positive/negative cytology

Sponsors and collaborators

Lead sponsor

Slagelse Hospital

Other

Collaborators

  • Lund University
  • Skane University Hospital

Registry information

Important dates

Study start
2020
Primary completion
2021
Study completion
2021
First posted
Jan 29, 2021
Registry last updated
Feb 10, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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