Rectal CancerPhase 3MTM-COLON-INCT01786694
Feasibility of Microdialysis by Laparoscopy
A Phase 3 study testing cma microdialysis catheter placement in people with Rectal Cancer, run by Centre Hospitalier Universitaire, Amiens at 1 site in France.
Trial summary
The aim of this pilot study is to evaluate the feasibility of microdialysis by laparoscopy in order to identify anastomotic leaks after rectal surgery. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Rectal Cancer
- What is being tested?
- cma microdialysis catheter placement
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 11 participants
- Where
- 1 siteFrance
- Study dates
- Oct 2013to Nov 2014
- Phase
- Phase 3
- 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
- rectal disease requiring proctectomy with anastomosis and stomy
- proctectomy by laparoscopy
- written consent
Who cannot join
- history of colorectal surgery
- rectal surgery without anastomosis
- breastfeeding or pregnancy
- ASA score IV
Trial locations and contacts
1 site in 1 country.
About this study
The aim of this pilot study is to evaluate the feasibility of microdialysis by laparoscopy in order to identify anastomotic leaks after rectal surgery.
- Conditions
- Rectal Cancer
- Being tested
- cma microdialysis catheter placement
- Keywords
- rectum, microdialysis, quality of life
- Medical subject headings
- Rectal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
cma microdialysis catheter placementDevice
the microdialysis catheters are sold by CMA
| Study group | Role | What they receive |
|---|---|---|
| cma microdialysis catheter placement | Experimental | At the end of the surgery the cma microdialysis catheter is placed near the anastomosis Receives: Device: cma microdialysis catheter placement |
What is being measured
The primary outcome is the main question the study is designed to answer.
functional success of microdialysis
the functional success of microdialysis is defined as abnormal values localised at the microdialysis catheter
Measured: postoperative day 5
Secondary outcomes (4)
anastomotic leaks rate
the anastomotic leaks rate is defined as the number of anastomotic leaks validated by a CT scan
Measured: postoperative day 30
superficial surgical site infection rate
the surgical site infection rate is defined as the number of infection near the incision
Measured: postoperative day 30
the mortality rate
the mortality rate is defined as the number of death after the surgery
Measured: postoperative day 30
the quality of life after the surgery
the quality of life will be evaluated with the QLQ C30 CR 29 prior to the surgery, at the hospital discharge and on postoperative day 30
Measured: postoperative day 30
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Feb 2013 (estimated)
- Study startOct 2013
- Primary completionOct 2014
- Study completionNov 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Rectal CancerStudies of the same condition, open and under way.
- More trials run by Centre Hospitalier Universitaire, AmiensThe sponsor's other registered studies.
- 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 3
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 11 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Universitaire, Amiens
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- jean marc regimbeau, MD, PhD, Principal investigator, CHU amiens
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01786694
- Sponsor's protocol ID
- PI2012_843_0022
- Other IDs
- 2012-A01218-35
- Acronym
- MTM-COLON-I
- Status last verified
- Jan 2017
- First submitted
- 1 Feb 2013
- Last updated
- 1 Feb 2017
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Hogberg N, Carlsson PO, Hillered L, Meurling S, Stenback A. Intestinal ischemia measured by intraluminal microdialysis. Scand J Clin Lab Invest. 2012 Feb;72(1):59-66. doi: 10.3109/00365513.2011.629307. Epub 2011 Nov 21.
PubMed 22103734Deeba S, Corcoles EP, Hanna GB, Pareskevas P, Aziz O, Boutelle MG, Darzi A. Use of rapid sampling microdialysis for intraoperative monitoring of bowel ischemia. Dis Colon Rectum. 2008 Sep;51(9):1408-13. doi: 10.1007/s10350-008-9375-4. Epub 2008 May 24.
PubMed 18500500Verdant CL, Chierego M, De Moor V, Chamlou R, Creteur J, de Dieu Mutijima J, Loi P, Gelin M, Gullo A, Vincent JL, De Backer D. Prediction of postoperative complications after urgent laparotomy by intraperitoneal microdialysis: A pilot study. Ann Surg. 2006 Dec;244(6):994-1002. doi: 10.1097/01.sla.0000225092.45734.e6.
PubMed 17122625
Study at a glance
From the registry record, last updated by the sponsor on 1 Feb 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Feasibility of Microdialysis by Laparoscopy
- ClinicalTrials.gov ID
- NCT01786694
- Acronym / sponsor ID
- MTM-COLON-I / PI2012_843_0022
- Conditions
- Rectal Cancer
- Keywords
- rectum, microdialysis, quality of life
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 11 participants (actual)
- Lead sponsor
- Centre Hospitalier Universitaire, AmiensUniversity, hospital or other
- Study start
- Oct 2013
- Primary completion
- Oct 2014 (actual)
- Study completion
- Nov 2014 (actual)
- First posted
- 8 Feb 2013 (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.
The aim of this pilot study is to evaluate the feasibility of microdialysis by laparoscopy in order to identify anastomotic leaks after rectal surgery.
Study design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| cma microdialysis catheter placement | Experimental | Device: cma microdialysis catheter placementAt the end of the surgery the cma microdialysis catheter is placed near the anastomosis |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- rectal disease requiring proctectomy with anastomosis and stomy
- proctectomy by laparoscopy
- written consent
Key exclusion criteria (4 listed)
- history of colorectal surgery
- rectal surgery without anastomosis
- breastfeeding or pregnancy
- ASA score IV
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 |
|---|---|---|
| cma microdialysis catheter placementthe microdialysis catheters are sold by CMA | Device | cma microdialysis catheter placement |
Primary outcome
functional success of microdialysis
Time frame: postoperative day 5
the functional success of microdialysis is defined as abnormal values localised at the microdialysis catheter
4 secondary outcomes
anastomotic leaks rate
Time frame: postoperative day 30
superficial surgical site infection rate
Time frame: postoperative day 30
the mortality rate
Time frame: postoperative day 30
the quality of life after the surgery
Time frame: postoperative day 30
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 1 Feb 2017.
- Background: PubMed 22103734Hogberg N, Carlsson PO, Hillered L, Meurling S, Stenback A. Intestinal ischemia measured by intraluminal microdialysis. Scand J Clin Lab Invest. 2012 Feb;72(1):59-66. doi: 10.3109/00365513.2011.629307. Epub 2011 Nov 21.
- Background: PubMed 18500500Deeba S, Corcoles EP, Hanna GB, Pareskevas P, Aziz O, Boutelle MG, Darzi A. Use of rapid sampling microdialysis for intraoperative monitoring of bowel ischemia. Dis Colon Rectum. 2008 Sep;51(9):1408-13. doi: 10.1007/s10350-008-9375-4. Epub 2008 May 24.
- Background: PubMed 17122625Verdant CL, Chierego M, De Moor V, Chamlou R, Creteur J, de Dieu Mutijima J, Loi P, Gelin M, Gullo A, Vincent JL, De Backer D. Prediction of postoperative complications after urgent laparotomy by intraperitoneal microdialysis: A pilot study. Ann Surg. 2006 Dec;244(6):994-1002. doi: 10.1097/01.sla.0000225092.45734.e6.
Related trials for Rectal Cancer
RecruitingPhase 1/2
A Phase 1 and 2 Study of VMD-102 in Hepatocellular Carcinoma and Other Solid Tumors
Hepatocellular Carcinoma (HCC), Metastatic Uveal Melanoma
Recruiting
Family Communications After Genetic Testing
Colon Adenocarcinoma, Colorectal Adenocarcinoma
Not yet recruitingPhase 1/2
Arginine-Restricted Diet Combined With Chemoradiotherapy in Neoadjuvant Rectal Cancer: A Phase Ib/II Trial
Rectal Cancer Patients
Not yet recruitingPhase 1
Hepatic Artery Infusion of Carfilzomib in Participants With Liver Metastatic Disease Previously Treated With Hepatic Artery Infusion Pump Therapy
Colorectal Neoplasms, Neoplasms
Not yet recruitingPhase 3
GFH375 Plus Cetuximab vs Investigator's Choice of Treatment in KRAS G12D-Mutant Refractory Metastatic Colorectal Cancer
Colorectal Cancer
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.
jean marc regimbeau, MD, PhD principal investigator
CHU amiens
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing cma microdialysis catheter placement in people with Rectal Cancer, run by Centre Hospitalier Universitaire, Amiens at 1 site in France.
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 3 inclusion and 4 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 1 Feb 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. 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.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
functional success of microdialysis (time frame: postoperative day 5). 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 NCT01786694, which also lists 3 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 1 Feb 2017.