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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
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Mechanical bowel preperation | mechanical bowel preparation with polyethylene glycol one day prior to surgery |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| polyethylene glycol | Drug | mechanical bowel preparation with polyethylene glycol one day prior to surgery |
|
| Measure | Description | Time Frame |
|---|---|---|
| anastomotic leak | clinical/drain/radiological leak | 30 days |
| Measure | Description | Time Frame |
|---|---|---|
| surgical site infection | superficial and deep surgical site infection | 14 days |
| Intraoperative parameters assessment | intraoperative assessment of tumor site, extend, operative time, intraoperative contamination |
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Inclusion Criteria:
Exclusion Criteria:
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Randomized open label study to assess effect of mechanical bowel preparation in elective laparoscopic surgery for left sided colon tumours
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| PVS Memorial Hospital | Recruiting | Kochi | Kerala | 682017 | India |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 18156032 | Background | 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. | |
| 15786427 |
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| ID | Term |
|---|---|
| D012004 | Rectal Neoplasms |
| D003110 | Colonic Neoplasms |
| ID | Term |
|---|---|
| D015179 | Colorectal Neoplasms |
| D007414 | Intestinal Neoplasms |
| D005770 | Gastrointestinal Neoplasms |
| D004067 | Digestive System Neoplasms |
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| ID | Term |
|---|---|
| D011092 | Polyethylene Glycols |
| C025749 | preparation No. 012074 |
| ID | Term |
|---|---|
| D005026 | Ethylene Glycols |
| D006018 | Glycols |
| D000438 | Alcohols |
| D009930 | Organic Chemicals |
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| No Preparation | Other | No laxatives or bowel preparation |
|
| 1 day |
| bowel recovery | Day of passage of flatus or faeces | 30 days |
| drain removal | postoperative day of drain removal | 30 days |
| Re-exploration | Any intervention radiological or surgical due to procedure related complications | 30 days |
| Hospital stay | postoperative hospital stay | 30 days |
| Readmission | admission to hospital after discharge due to any reasons | 30days |
| Bucher 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. |
| 21901677 | Background | Guenaga 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. |
| 21871987 | Background | van'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. |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D004066 | Digestive System Diseases |
| D005767 | Gastrointestinal Diseases |
| D007410 | Intestinal Diseases |
| D012002 | Rectal Diseases |
| D003108 | Colonic Diseases |
| D011108 |
| Polymers |
| D046911 | Macromolecular Substances |
| D001697 | Biomedical and Dental Materials |
| D008420 | Manufactured Materials |
| D013676 | Technology, Industry, and Agriculture |