NCT01465945

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
50

participants targeted

Target at below P25 for not_applicable postoperative-pain

Timeline
Completed

Started Mar 2012

Typical duration for not_applicable postoperative-pain

Geographic Reach
1 country

3 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 31, 2011

Completed
7 days until next milestone

First Posted

Study publicly available on registry

November 7, 2011

Completed
4 months until next milestone

Study Start

First participant enrolled

March 1, 2012

Completed
1.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2013

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2013

Completed
Last Updated

July 22, 2014

Status Verified

July 1, 2014

Enrollment Period

1.6 years

First QC Date

October 31, 2011

Last Update Submit

July 19, 2014

Conditions

Post-operative PainComplications

Keywords

TEM for rectal lesionsSutured defectUnsutured defect

Outcome Measures

Primary Outcomes (1)

  • Postoperative Pain

    As an ancillary measure, all patients will be prescribed 30 tablets of either Tylenol#3 or Tramacet as as their primary postoperative analgesic.

    1day after surgery

Secondary Outcomes (1)

  • Complications

    within 30 days of surgery

Study Arms (2)

Rectal Defect Sutured

OTHER

The subject will have his/her defect sutured after the rectal tumors have been removed.

Procedure: Defect Sutured

Rectal Defect Unsutured

OTHER

The defect will be left open and let naturally close after the rectal tumor has been removed by TEM.

Procedure: Defect Unsutured

Interventions

Defect UnsuturedPROCEDURE

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

Rectal Defect Unsutured
Defect SuturedPROCEDURE

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

Rectal Defect Sutured

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may not qualify if:

  • 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)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

Saint Paul's Hospital

Vancouver, British Columbia, V6Z 1Y6, Canada

Location

Vancouver General Hospital

Winnipeg, Manitoba, V8Z 6R5, Canada

Location

The Ottawa Hospital

Ottawa, Ontario, K1H 8L6, Canada

Location

Related Publications (9)

  • McCourt M, Armitage J, Monson JR. Rectal cancer. Surgeon. 2009 Jun;7(3):162-9. doi: 10.1016/s1479-666x(09)80040-1.

    PMID: 19580180BACKGROUND

  • Buess G, Hutterer F, Theiss J, Bobel M, Isselhard W, Pichlmaier H. [A system for a transanal endoscopic rectum operation]. Chirurg. 1984 Oct;55(10):677-80. No abstract available. German.

    PMID: 6510078BACKGROUND

  • Allaix ME, Arezzo A, Caldart M, Festa F, Morino M. Transanal endoscopic microsurgery for rectal neoplasms: experience of 300 consecutive cases. Dis Colon Rectum. 2009 Nov;52(11):1831-6. doi: 10.1007/DCR.0b013e3181b14d2d.

    PMID: 19966628BACKGROUND

  • Ramirez JM, Aguilella V, Arribas D, Martinez M. Transanal full-thickness excision of rectal tumours: should the defect be sutured? a randomized controlled trial. Colorectal Dis. 2002 Jan;4(1):51-55. doi: 10.1046/j.1463-1318.2002.00293.x.

    PMID: 12780656BACKGROUND

  • Gallagher EJ, Bijur PE, Latimer C, Silver W. Reliability and validity of a visual analog scale for acute abdominal pain in the ED. Am J Emerg Med. 2002 Jul;20(4):287-90. doi: 10.1053/ajem.2002.33778.

    PMID: 12098173BACKGROUND

  • Festen S, van Hoogstraten MJ, van Geloven AA, Gerhards MF. Treatment of grade III and IV haemorrhoidal disease with PPH or THD. A randomized trial on postoperative complications and short-term results. Int J Colorectal Dis. 2009 Dec;24(12):1401-5. doi: 10.1007/s00384-009-0803-2.

    PMID: 19798507BACKGROUND

  • Todd KH, Funk KG, Funk JP, Bonacci R. Clinical significance of reported changes in pain severity. Ann Emerg Med. 1996 Apr;27(4):485-9. doi: 10.1016/s0196-0644(96)70238-x.

    PMID: 8604867BACKGROUND

  • Kelly AM. The minimum clinically significant difference in visual analogue scale pain score does not differ with severity of pain. Emerg Med J. 2001 May;18(3):205-7. doi: 10.1136/emj.18.3.205.

    PMID: 11354213BACKGROUND

  • Burch J, Epstein D, Baba-Akbari A, Weatherly H, Fox D, Golder S, Jayne D, Drummond M, Woolacott N. Stapled haemorrhoidectomy (haemorrhoidopexy) for the treatment of haemorrhoids: a systematic review and economic evaluation. Health Technol Assess. 2008 Apr;12(8):iii-iv, ix-x, 1-193. doi: 10.3310/hta12080.

    PMID: 18373905BACKGROUND

MeSH Terms

Conditions

Pain, Postoperative

Condition Hierarchy (Ancestors)

Postoperative ComplicationsPathologic ProcessesPathological Conditions, Signs and SymptomsPainNeurologic ManifestationsSigns and Symptoms

Study Officials

  • Carl J Brown, MD, MSc

    Saint Paul's Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Head, Division of General Surgery, clinical assistant professor of surgery at University of British Columbia

Study Record Dates

First Submitted

October 31, 2011

First Posted

November 7, 2011

Study Start

March 1, 2012

Primary Completion

October 1, 2013

Study Completion

October 1, 2013

Last Updated

July 22, 2014

Record last verified: 2014-07

Locations

CA(3)