Post-operative PainNCT01465945
Study of Unsutured Versus Sutured Closure of Rectal Defects After Rectal Lesion Excisions Using Transanal Endoscopic Microsurgery
A study testing Defect Unsutured and Defect Sutured in people with Post-operative Pain and Complications, run by Dr. Carl J Brown at 3 sites in Canada.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Post-operative Pain, Complications
- What is being tested?
- Defect Unsutured and Defect Sutured
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 3 sitesCanada
- Study dates
- Mar 2012to Oct 2013
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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)
Trial locations and contacts
3 sites in 1 country.
Canada3 sites
The Ottawa Hospital
Ottawa, Ontario, K1H 8L6
Saint Paul's Hospital
Vancouver, British Columbia, V6Z 1Y6
Vancouver General Hospital
Winnipeg, Manitoba, V8Z 6R5
About this study
Official title: A Randomized Clinical Trial of Open Versus Suture Closure in Patients With Rectal Lesions Excised Using Transanal Endoscopic Microsurgery
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.
Read the 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.
- Conditions
- Post-operative Pain, Complications
- Being tested
- Defect Unsutured, Defect Sutured
- Keywords
- TEM for rectal lesions, Sutured defect, Unsutured defect
- Medical subject headings
- Pain, Postoperative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Defect UnsuturedProcedure or surgery
The defect is not sutured after the rectal tumor is removed by TEM.
Defect SuturedProcedure or surgery
Defect is sutured after the rectal tumor has been removed by TEM.
| Study group | Role | What they receive |
|---|---|---|
| Rectal Defect Sutured | Other | The subject will have his/her defect sutured after the rectal tumors have been removed. Receives: 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. Receives: Procedure: Defect Unsutured |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 1day after surgery
Secondary outcomes (1)
Complications
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.
Measured: within 30 days of surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Nov 2011 (estimated)
- Study startMar 2012
- Primary completionOct 2013
- Study completionOct 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (9)Papers the sponsor has linked to this study.
- Other trials for Post-operative PainStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Dr. Carl J Brown
- Sponsor type
- University, hospital or other
- Collaborators
- Canadian Society of Colon and Rectal Surgeons
- Responsible party
- Sponsor-investigator, Dr. Carl J Brown, St. Paul's Hospital, Canada
- Investigators
- Carl J Brown, MD, MSc, Principal investigator, Saint Paul's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01465945
- Sponsor's protocol ID
- TEMPEST
- Status last verified
- Jul 2014
- First submitted
- 31 Oct 2011
- Last updated
- 22 Jul 2014
- Results posted
- No
- Data monitoring committee
- No
Publications
McCourt M, Armitage J, Monson JR. Rectal cancer. Surgeon. 2009 Jun;7(3):162-9. doi: 10.1016/s1479-666x(09)80040-1.
PubMed 19580180Buess 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.
PubMed 6510078Allaix 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.
PubMed 19966628Ramirez 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.
PubMed 12780656Gallagher 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.
PubMed 12098173Festen 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.
PubMed 19798507Todd 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.
PubMed 8604867Kelly 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.
PubMed 11354213Burch 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.
PubMed 18373905
Study at a glance
From the registry record, last updated by the sponsor on 22 Jul 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Clinical Trial of Open Versus Suture Closure in Patients With Rectal Lesions Excised Using Transanal Endoscopic Microsurgery
- ClinicalTrials.gov ID
- NCT01465945
- Acronym / sponsor ID
- TEMPEST
- Conditions
- Post-operative Pain, Complications
- Keywords
- TEM for rectal lesions, Sutured defect, Unsutured defect
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Dr. Carl J BrownUniversity, hospital or other
- Collaborators
- Canadian Society of Colon and Rectal Surgeons
- Study start
- Mar 2012
- Primary completion
- Oct 2013 (actual)
- Study completion
- Oct 2013 (actual)
- First posted
- 7 Nov 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Rectal Defect Sutured | Other | Procedure: Defect SuturedThe subject will have his/her defect sutured after the rectal tumors have been removed. |
| Rectal Defect Unsutured | Other | Procedure: Defect UnsuturedThe defect will be left open and let naturally close after the rectal tumor has been removed by TEM. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- 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.
Key exclusion criteria (3 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Defect UnsuturedThe defect is not sutured after the rectal tumor is removed by TEM. | Procedure or surgery | Rectal Defect Unsutured |
| Defect SuturedDefect is sutured after the rectal tumor has been removed by TEM. | Procedure or surgery | Rectal Defect Sutured |
Primary outcome
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.
1 secondary outcome
Complications
Time frame: within 30 days of surgery
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Jul 2014.
- Background: PubMed 19580180McCourt M, Armitage J, Monson JR. Rectal cancer. Surgeon. 2009 Jun;7(3):162-9. doi: 10.1016/s1479-666x(09)80040-1.
- Background: PubMed 6510078Buess 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.
- Background: PubMed 19966628Allaix 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.
- Background: PubMed 12780656Ramirez 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.
- Background: PubMed 12098173Gallagher 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.
- Background: PubMed 19798507Festen 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.
- Background: PubMed 8604867Todd 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.
- Background: PubMed 11354213Kelly 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.
- Background: PubMed 18373905Burch 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Carl J Brown, MD, MSc principal investigator
Saint Paul's Hospital
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Defect Unsutured and Defect Sutured in people with Post-operative Pain and Complications, run by Dr. Carl J Brown at 3 sites in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 22 Jul 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Postoperative Pain (time frame: 1day after surgery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01465945, which also lists 9 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Jul 2014.