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

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ClinicalTrials.gov Identifier: NCT01465945
Recruitment Status : Completed
First Posted : November 6, 2011
Last Update Posted : July 22, 2014
Sponsor:
Collaborator:
Canadian Society of Colon and Rectal Surgeons
Information provided by (Responsible Party):
Dr. Carl J Brown, St. Paul's Hospital, Canada

Tracking Information
First Submitted Date  ICMJE October 31, 2011
First Posted Date  ICMJE November 6, 2011
Last Update Posted Date July 22, 2014
Study Start Date  ICMJE March 2012
Actual Primary Completion Date October 2013   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: December 18, 2011)
Postoperative Pain [ Time Frame: 1day after surgery ]
As an ancillary measure, all patients will be prescribed 30 tablets of either Tylenol#3 or Tramacet as as their primary postoperative analgesic.
Original Primary Outcome Measures  ICMJE
 (submitted: November 2, 2011)
Changes in Postoperative Pain [ Time Frame: 1,3,7 days after surgery ]
As an ancillary measure, all patients will be prescribed 30 tablets of either Tylenol#3 or Tramacet as as their primary postoperative analgesic.
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: December 18, 2011)
Complications [ Time Frame: within 30 days of surgery ]
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.
Original Secondary Outcome Measures  ICMJE
 (submitted: November 2, 2011)
Changes in Complications [ Time Frame: within 30 days of surgery ]
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.
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Study of Unsutured Versus Sutured Closure of Rectal Defects After Rectal Lesion Excisions Using Transanal Endoscopic Microsurgery
Official Title  ICMJE A Randomized Clinical Trial of Open Versus Suture Closure in Patients With Rectal Lesions Excised Using Transanal Endoscopic Microsurgery
Brief 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.

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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE
  • Post-operative Pain
  • Complications
Intervention  ICMJE
  • 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.
Study Arms  ICMJE
  • Rectal Defect Sutured
    The subject will have his/her defect sutured after the rectal tumors have been removed.
    Intervention: Procedure: Defect Sutured
  • Rectal Defect Unsutured
    The defect will be left open and let naturally close after the rectal tumor has been removed by TEM.
    Intervention: Procedure: Defect Unsutured
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: July 19, 2014)
50
Original Estimated Enrollment  ICMJE
 (submitted: November 2, 2011)
38
Actual Study Completion Date  ICMJE October 2013
Actual Primary Completion Date October 2013   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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)
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Canada
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01465945
Other Study ID Numbers  ICMJE TEMPEST
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Dr. Carl J Brown, St. Paul's Hospital, Canada
Study Sponsor  ICMJE Dr. Carl J Brown
Collaborators  ICMJE Canadian Society of Colon and Rectal Surgeons
Investigators  ICMJE
Principal Investigator: Carl J Brown, MD, MSc Saint Paul's Hospital
PRS Account St. Paul's Hospital, Canada
Verification Date July 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP