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Study of Unsutured Versus Sutured Closure of Rectal Defects After Rectal Lesion Excisions Using Transanal Endoscopic Microsurgery

NCT01465945 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 50

Last updated 2014-07-22

No results posted yet for this study

Summary

Transanal Endoscopic Microsurgery (TEM) is a minimally invasive technique used to remove rectal tumours. After the tumour has been removed from the rectum, the surgeon has a choice to close the defect or leave the defect open and naturally close. Currently, both options are accepted as standard care.

Leaving the defect open to close naturally has some possible advantages, including shortened operation time and similar rates of postoperative complications. However, there is some concern that not surgically closing the defect may lead to more postoperative pain and delay in recovery.

The study will be a double blind randomized controlled trial and determine whether patients who have rectal wall defect sutured closed have less post-operative pain compared to patients whose defect is left open.

Conditions

  • Post-operative Pain
  • Complications

Interventions

PROCEDURE

Defect Unsutured

The defect is not sutured after the rectal tumor is removed by TEM.

PROCEDURE

Defect Sutured

Defect is sutured after the rectal tumor has been removed by TEM.

Sponsors & Collaborators

  • Canadian Society of Colon and Rectal Surgeons

    collaborator OTHER

  • Dr. Carl J Brown

    lead OTHER

Principal Investigators

  • Carl J Brown, MD, MSc · Saint Paul's Hospital

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2012-03-31
Primary Completion
2013-10-31
Completion
2013-10-31

Countries

  • Canada

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01465945 on ClinicalTrials.gov