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

NCT04730102 | Completed DMC

• 3 other identifiers: SJ-8172019-2567ALF Region Skåne
• Study Type: observational
• Target: 21
• Locations: 1 country
• Sites: 1

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.

Conditions

Rectal Cancer

Keywords

Rectal washout; transanal total mesorectal excision; rectal cancer

Outcome Measures

Primary Outcomes (1)

• Existence of intraluminal malignant cells in fluid samples from rectal washout

  Positive/negative cytology

  Intraoperatively

Secondary Outcomes (1)

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

  Intraoperatively

Study Arms (1)

Patients undergoing rectal washout in transanal mesorectal excision

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

Procedure: Rectal washout

Interventions

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.

Patients undergoing rectal washout in transanal mesorectal excision

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients undergoing transanal mesorectal excision at Slagelse Hospital, Denmark

You may qualify if:

• Surgery at Slagelse Hospital for rectal cancer with transanal mesorectal excision
• Consent to participate in the study

You may not qualify if:

• No consent to participate
• No surgery

Sponsors & Collaborators

• Slagelse Hospital: lead
• Skane University Hospital: collaborator
• Lund University: collaborator

Study Sites (1)

Slagelse Hospital

Slagelse, Region Sjælland, 4200, Denmark

Location

MeSH Terms

Conditions

Rectal Neoplasms

Condition Hierarchy (Ancestors)

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

Study Officials

• Pamela Buchwald

  Skåne University Hospital, Malmö, Region Skåne, Sweden

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 25, 2021
• First Posted: January 29, 2021
• Study Start: February 13, 2020
• Primary Completion: February 9, 2021
• Study Completion: February 9, 2021
• Last Updated: February 10, 2021

Record last verified: 2021-02

Data Sharing

• IPD Sharing: Will not share

Locations

DK (1)