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

• Sponsor: Slagelse Hospital (Other)
• Overall Status: Completed
• CT.gov ID: NCT04730102
• Collaborator: Skane University Hospital (Other), Lund University (Other)
• Enrollment: 21
• Location: 1
• Actual Duration (Months): 11.9
• Patients Per Site Per Month: 1.8

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Rectal Cancer	Procedure: Rectal washout

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.

Study Design

• Study Type: Observational
• Actual Enrollment: 21 participants
• Observational Model: Cohort
• Time Perspective: Cross-Sectional
• Official Title: Rectal Washout in Transanal Total Mesorectal Excision and Presence of Intraluminal Malignant Cells
• Actual Study Start Date: Feb 13, 2020
• Actual Primary Completion Date: Feb 9, 2021
• Actual Study Completion Date: Feb 9, 2021

Arms and Interventions

Arm

Intervention/Treatment

Patients undergoing rectal washout in transanal mesorectal excision Patients undergoing rectal washout in transanal mesorectal excision for rectal cancer.

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.

Outcome Measures

Primary Outcome Measures

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

   Positive/negative cytology

Secondary Outcome Measures

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

   Positive/negative cytology

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Slagelse Hospital	Slagelse	Zealand	Denmark	4200

Sponsors and Collaborators

• Slagelse Hospital
• Skane University Hospital
• Lund University

Investigators

• Principal Investigator: Pamela Buchwald, Skåne University Hospital, Malmö, Region Skåne, Sweden

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Slagelse Hospital
• ClinicalTrials.gov Identifier: NCT04730102
• Other Study ID Numbers: SJ-817; 2019-2567; ALF Region Skåne
• First Posted: Jan 29, 2021
• Last Update Posted: Feb 10, 2021
• Last Verified: Feb 1, 2021

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by Slagelse Hospital: Rectal washout; transanal total mesorectal excision; rectal cancer
• Additional relevant MeSH terms: Rectal Neoplasms

Study Results

No Results Posted as of Feb 10, 2021