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

This study has been completed.
Sponsor:
Collaborator:
Canadian Society of Colon and Rectal Surgeons
Information provided by (Responsible Party):
Dr. Carl J Brown, St. Paul's Hospital, Canada
ClinicalTrials.gov Identifier:
NCT01465945
First received: October 31, 2011
Last updated: July 19, 2014
Last verified: July 2014
  Purpose

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.


Condition Intervention
Post-operative Pain
Complications
Procedure: Defect Unsutured
Procedure: Defect Sutured

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Randomized Clinical Trial of Open Versus Suture Closure in Patients With Rectal Lesions Excised Using Transanal Endoscopic Microsurgery

Resource links provided by NLM:


Further study details as provided by St. Paul's Hospital, Canada:

Primary Outcome Measures:
  • Postoperative Pain [ Time Frame: 1day after surgery ] [ Designated as safety issue: Yes ]
    As an ancillary measure, all patients will be prescribed 30 tablets of either Tylenol#3 or Tramacet as as their primary postoperative analgesic.


Secondary Outcome Measures:
  • Complications [ Time Frame: within 30 days of surgery ] [ Designated as safety issue: Yes ]
    includes bleeding( defined as hemoglobin drop of 20g/L from preoperative and either transfusion, readmission to hospital, or surgical or endoscopic intervention), infection (peritonitis or pelvic pain and either fever >37.9 degC or WBC > 11 X 10^9 c/L), and readmission to hospital for any reason.


Enrollment: 50
Study Start Date: March 2012
Study Completion Date: October 2013
Primary Completion Date: October 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Rectal Defect Sutured
The subject will have his/her defect sutured after the rectal tumors have been removed.
Procedure: Defect Sutured
Defect is sutured after the rectal tumor has been removed by TEM.
Rectal Defect Unsutured
The defect will be left open and let naturally close after the rectal tumor has been removed by TEM.
Procedure: Defect Unsutured
The defect is not sutured after the rectal tumor is removed by TEM.

Detailed Description:

Summary

Background Transanal Endoscopic Microsurgery (TEM) is an advanced minimally invasive endoluminal technique used to remove rectal tumours. In the open transanal excision era, there is evidence that outcomes in unsutured rectal defects are similar to those in patients whose defect is closed. However, the evidence for this approach is minimal and technical differences in TEM (e.g. rectal insufflation) may mean that leaving defects unsutured is not a safe approach. Further, there is anecdotal evidence that unsutured defects lead to more postoperative pain and delay recovery.

Objective The purpose of this study is to determine if postoperative pain (primary) and early postoperative complications (secondary) are worse in patients undergoing TEM and do not have the defect closed when compare to similar patients who have endoluminal suture closure of the defect.

Methods This is a multicentre, double blind randomized controlled trial of suture closure versus no closure in patients treated by TEM for rectal lesions. The study will include patients 18 years and older with rectal lesions within 12cm of the anal verge treated with TEM. The primary outcome is postoperative pain as measured by validated visual analogue scale (VAS). Secondary outcomes include analgesic use and early (<30 day) complications. Based on anticipated VAS scores, a sample size of 38 patients will be enrolled (power 0.80, α=0.05). Statistical analysis will be performed using student's T test for continuous data and Fischer's exact test for dichotomous variables.

Impact Currently, only 3 centres in Canada have experience with TEM: Vancouver, Winnipeg and Ottawa. This study represents the first trial of a Canadian TEM Collaborative and will determine if there is an advantage to suture closure of the rectal defect in TEM surgery. This is important, as suture technique is challenging and if there are important advantages to this approach, there would be a mandate to perfect suturing technique before employing the TEM approach to rectal tumours. Conversely, if there is an advantage to leaving the defect unsutured, this may reduce operative time and facilitate better use of OR time. Further, it will inform all TEM surgeons of the best approach to the rectal defect and optimize patient care. Finally, this study will serve as a starting point for further trials by the Canadian TEM Collaborative that will expand to include new sites and become a world leader in TEM clinical trials.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • The patients must be over 18 years old with a rectal lesion < 12cm from the anal verge (as measured by rigid sigmoidoscopy) and less than half the circumference of the rectal lumen. The patient must provide informed consent for TEM and inclusion in the trial.

Exclusion Criteria:

  • The surgeon decides to convert to laparotomy or conventional TAE for any reason during tumor excision.
  • The surgeon judges that the rectal defect is not appropriate for suturing (e.g. too large) or to be left unsutured (e.g. entry into peritoneal cavity)
  • The patient is currently treated for chronic pain prior to surgery, has a known bleeding diathesis (e.g. warfarin treatment, hemophilia, etc) or is immunosuppressed (e.g. Prednisone, HIV,etc)
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01465945

Locations
Canada, British Columbia
Saint Paul's Hospital
Vancouver, British Columbia, Canada, V6Z 1Y6
Canada, Manitoba
Vancouver General Hospital
Winnipeg, Manitoba, Canada, V8Z 6R5
Canada, Ontario
The Ottawa Hospital
Ottawa, Ontario, Canada, K1H 8L6
Sponsors and Collaborators
Dr. Carl J Brown
Canadian Society of Colon and Rectal Surgeons
Investigators
Principal Investigator: Carl J Brown, MD, MSc Saint Paul's Hospital
  More Information

Publications:

Responsible Party: Dr. Carl J Brown, Head, Division of General Surgery, clinical assistant professor of surgery at University of British Columbia, St. Paul's Hospital, Canada
ClinicalTrials.gov Identifier: NCT01465945     History of Changes
Other Study ID Numbers: TEMPEST
Study First Received: October 31, 2011
Last Updated: July 19, 2014
Health Authority: Canada: Ethics Review Committee

Keywords provided by St. Paul's Hospital, Canada:
TEM for rectal lesions
Sutured defect
Unsutured defect

Additional relevant MeSH terms:
Pain, Postoperative
Postoperative Complications
Pathologic Processes
Pain
Signs and Symptoms

ClinicalTrials.gov processed this record on September 30, 2014