Rectal CancerMBPNCT01797770
Trial on Mechanical Bowel Preparation in Laparoscopic Colorectal Surgery
An observational study of Rectal Cancer and Colon Cancer, run by PVS Memorial Hospital at 1 site in India.
Trial summary
This is a Randomized trial on Mechanical Bowel Preparation in Laparoscopic Colorectal Surgery. In this trial patients with left sided colon and rectal tumors were randomized to receive mechanical bowel preparation or no preparation to assess postoperative complications and outcome Read more about this study
- Who is it for?
- Ages 25 to 75 years
- Conditions the study is for
- Rectal Cancer, Colon Cancer
- What is being tested?
- polyethylene glycol and No Preparation
- How many people
- 90 participants
- Where
- 1 siteIndia
- Study dates
- Jan 2012to Feb 2014
- Phase
- Observational
- 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 25 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Randomized open label study to assess effect of mechanical bowel preparation in elective laparoscopic surgery for left sided colon tumours
Who may be able to join
- left sided colonic and rectal tumors
- eligible for elective laparoscopic surgery
Who cannot join
- Patients with intestinal obstruction or perforation.
- patients with T4b tumors.
- metastatic tumors
- patients with multiple previous abdominal surgeries
Trial locations and contacts
1 site in 1 country.
India1 site, 1 recruiting
- Recruiting
PVS Memorial Hospital
Kochi, Kerala, 682017
Prakash Kurumboor, MS, MCh, 09447302588, drkprakash@vsnl.com
Pramil K, MS
About this study
Official title: A Randomised Controlled Trial On Mechanical Bowel Preparation Versus No Mechanical Bowel Preparation In Elective Laparoscopic Surgery For Left Sided Colonic Tumours
This is a Randomized trial on Mechanical Bowel Preparation in Laparoscopic Colorectal Surgery. In this trial patients with left sided colon and rectal tumors were randomized to receive mechanical bowel preparation or no preparation to assess postoperative complications and outcome
Read the detailed description
In this prospective randomized trial,patients were randomized to receive mechanical bowel preparation or no preparation to assess postoperative complications and outcome following elective laparoscopic surgery for left sided colon and rectal tumors. Randomization is done from the out -patient department at the time of admission, using random numbers from a computer generated list from a sealed envelope method.
Patients who did not have mechanical bowel preparation had a normal meal on the day before the operation. Those who did were given a fluid diet, and mechanical bowel preparation with polyethylene glycol one day prior to surgery.
Both groups will have the scheduled laparoscopic colonic resections. Use of diverting stoma is left to the discretion of the operating surgeon. Cases that needed a diverting stoma, will be analyzed separately.
- Conditions
- Rectal Cancer, Colon Cancer
- Being tested
- polyethylene glycol, No Preparation
- Keywords
- mechanical bowel preparation, Colon Cancer
- Medical subject headings
- Rectal Neoplasms, Colonic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
polyethylene glycolDrug
mechanical bowel preparation with polyethylene glycol one day prior to surgery
No PreparationOther
No laxatives or bowel preparation
| Study group | Role | What they receive |
|---|---|---|
| Mechanical bowel preperation | mechanical bowel preparation with polyethylene glycol one day prior to surgery Receives: Drug: polyethylene glycol; Other: No Preparation |
What is being measured
The primary outcome is the main question the study is designed to answer.
anastomotic leak
clinical/drain/radiological leak
Measured: 30 days
Secondary outcomes (7)
surgical site infection
superficial and deep surgical site infection
Measured: 14 days
Intraoperative parameters assessment
intraoperative assessment of tumor site, extend, operative time, intraoperative contamination
Measured: 1 day
bowel recovery
Day of passage of flatus or faeces
Measured: 30 days
drain removal
postoperative day of drain removal
Measured: 30 days
Re-exploration
Any intervention radiological or surgical due to procedure related complications
Measured: 30 days
Hospital stay
postoperative hospital stay
Measured: 30 days
Readmission
admission to hospital after discharge due to any reasons
Measured: 30days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Feb 2013 (estimated)
- Study startJan 2012
- Primary completionJan 2014 (estimated)
- Study completionFeb 2014 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Rectal CancerStudies 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
- Observational
- Time perspective
- Prospective
- Enrolment
- 90 participants (estimated)
Sponsor and investigators
- Lead sponsor
- PVS Memorial Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dr Prakash K, PVS Memorial Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01797770
- Sponsor's protocol ID
- PVS2
- Acronym
- MBP
- Status last verified
- Feb 2013
- First submitted
- 16 Sep 2012
- Last updated
- 22 Feb 2013
- Results posted
- No
- Data monitoring committee
- No
Publications
Contant CM, Hop WC, van't Sant HP, Oostvogel HJ, Smeets HJ, Stassen LP, Neijenhuis PA, Idenburg FJ, Dijkhuis CM, Heres P, van Tets WF, Gerritsen JJ, Weidema WF. Mechanical bowel preparation for elective colorectal surgery: a multicentre randomised trial. Lancet. 2007 Dec 22;370(9605):2112-7. doi: 10.1016/S0140-6736(07)61905-9.
PubMed 18156032Bucher P, Gervaz P, Soravia C, Mermillod B, Erne M, Morel P. Randomized clinical trial of mechanical bowel preparation versus no preparation before elective left-sided colorectal surgery. Br J Surg. 2005 Apr;92(4):409-14. doi: 10.1002/bjs.4900.
PubMed 15786427Guenaga KF, Matos D, Wille-Jorgensen P. Mechanical bowel preparation for elective colorectal surgery. Cochrane Database Syst Rev. 2011 Sep 7;2011(9):CD001544. doi: 10.1002/14651858.CD001544.pub4.
PubMed 21901677van't Sant HP, Weidema WF, Hop WC, Lange JF, Contant CM. Evaluation of morbidity and mortality after anastomotic leakage following elective colorectal surgery in patients treated with or without mechanical bowel preparation. Am J Surg. 2011 Sep;202(3):321-4. doi: 10.1016/j.amjsurg.2010.10.018.
PubMed 21871987
Study at a glance
From the registry record, last updated by the sponsor on 22 Feb 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomised Controlled Trial On Mechanical Bowel Preparation Versus No Mechanical Bowel Preparation In Elective Laparoscopic Surgery For Left Sided Colonic Tumours
- ClinicalTrials.gov ID
- NCT01797770
- Acronym / sponsor ID
- MBP / PVS2
- Conditions
- Rectal Cancer, Colon Cancer
- Keywords
- mechanical bowel preparation, Colon Cancer
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 90 participants (estimated)
- Lead sponsor
- PVS Memorial HospitalUniversity, hospital or other
- Study start
- Jan 2012
- Primary completion
- Jan 2014 (estimated)
- Study completion
- Feb 2014 (estimated)
- First posted
- 22 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.
This is a Randomized trial on Mechanical Bowel Preparation in Laparoscopic Colorectal Surgery. In this trial patients with left sided colon and rectal tumors were randomized to receive mechanical bowel preparation or no preparation to assess postoperative complications and outcome
Detailed description
In this prospective randomized trial,patients were randomized to receive mechanical bowel preparation or no preparation to assess postoperative complications and outcome following elective laparoscopic surgery for left sided colon and rectal tumors. Randomization is done from the out -patient department at the time of admission, using random numbers from a computer generated list from a sealed envelope method.
Patients who did not have mechanical bowel preparation had a normal meal on the day before the operation. Those who did were given a fluid diet, and mechanical bowel preparation with polyethylene glycol one day prior to surgery.
Both groups will have the scheduled laparoscopic colonic resections. Use of diverting stoma is left to the discretion of the operating surgeon. Cases that needed a diverting stoma, will be analyzed separately.
Study design
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Mechanical bowel preperation | – | Drug: polyethylene glycol, Other: No Preparationmechanical bowel preparation with polyethylene glycol one day prior to surgery |
Who may qualify
- Ages
- 25 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Randomized open label study to assess effect of mechanical bowel preparation in elective laparoscopic surgery for left sided colon tumours
Key inclusion criteria (2 listed)
- left sided colonic and rectal tumors
- eligible for elective laparoscopic surgery
Key exclusion criteria (4 listed)
- Patients with intestinal obstruction or perforation.
- patients with T4b tumors.
- metastatic tumors
- patients with multiple previous abdominal surgeries
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 |
|---|---|---|
| polyethylene glycolmechanical bowel preparation with polyethylene glycol one day prior to surgery | Drug | Mechanical bowel preperation |
| No PreparationNo laxatives or bowel preparation | Other | Mechanical bowel preperation |
Primary outcome
anastomotic leak
Time frame: 30 days
clinical/drain/radiological leak
7 secondary outcomes
surgical site infection
Time frame: 14 days
Intraoperative parameters assessment
Time frame: 1 day
bowel recovery
Time frame: 30 days
drain removal
Time frame: 30 days
Re-exploration
Time frame: 30 days
Hospital stay
Time frame: 30 days
Readmission
Time frame: 30days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Feb 2013.
- Background: PubMed 18156032Contant CM, Hop WC, van't Sant HP, Oostvogel HJ, Smeets HJ, Stassen LP, Neijenhuis PA, Idenburg FJ, Dijkhuis CM, Heres P, van Tets WF, Gerritsen JJ, Weidema WF. Mechanical bowel preparation for elective colorectal surgery: a multicentre randomised trial. Lancet. 2007 Dec 22;370(9605):2112-7. doi: 10.1016/S0140-6736(07)61905-9.
- Background: PubMed 15786427Bucher P, Gervaz P, Soravia C, Mermillod B, Erne M, Morel P. Randomized clinical trial of mechanical bowel preparation versus no preparation before elective left-sided colorectal surgery. Br J Surg. 2005 Apr;92(4):409-14. doi: 10.1002/bjs.4900.
- Background: PubMed 21901677Guenaga KF, Matos D, Wille-Jorgensen P. Mechanical bowel preparation for elective colorectal surgery. Cochrane Database Syst Rev. 2011 Sep 7;2011(9):CD001544. doi: 10.1002/14651858.CD001544.pub4.
- Background: PubMed 21871987van't Sant HP, Weidema WF, Hop WC, Lange JF, Contant CM. Evaluation of morbidity and mortality after anastomotic leakage following elective colorectal surgery in patients treated with or without mechanical bowel preparation. Am J Surg. 2011 Sep;202(3):321-4. doi: 10.1016/j.amjsurg.2010.10.018.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Rectal Cancer and Colon Cancer, run by PVS Memorial Hospital at 1 site in India.
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 2 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: status not confirmed, as of the sponsor's last update on 22 Feb 2013. 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 India. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
anastomotic leak (time frame: 30 days). 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 NCT01797770, which also lists 4 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 Feb 2013.