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| ID | Type | Description | Link |
|---|---|---|---|
| AOM 06086 | |||
| IDRCB 2007-A00471 |
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The aim of this controlled multicentric study is to assess rectal cancer surgery with sphincter preservation without pre operative mechanical bowel preparation
Preoperative mechanical bowel preparation (MBP) (i.e. including oral laxatives, retrograde enemas and/or oral diet before surgery) is the standard practice in colorectal surgery. The importance of MBP in preventing anastomotic leakage and infectious morbidity after elective colorectal surgery has been a dogma among surgeons for many years. The main reason is the belief that postoperative complications is related to septic bowel content. However, there is a paucity of scientific evidence demonstrating the efficacy of this practice in reducing morbidity. Moreover, potential disadvantages of MBP include the requirement for a longer preoperative duration of admission before surgery, its time consuming nature, being expensive and unpleasant for the patient and expose the early population to the particular risk of fluid and electrolyte imbalance .At least eight randomized clinical trials and two meta-analyses failed to show any superiority of MBP in colorectal surgery. On the contrary, they demonstrated that preparation might lead to an increased rate of septic complications. Such initial dates lead surgeons to re-evaluate their current clinical practice in colonic surgery. But to dates, these findings cannot finally be applied to rectal surgery because of insufficient dates. To date, no study about MBP was specifically devoted to rectal surgery. Moreover, it is currently admitted that the risk of septic complications following rectal resection, as a result of the well-known risk factors, is higher than after colonic preparation. It is the reason why most of the colorectal surgeons consider that a no preparation regimen in rectal cancer surgery could represent an additive risk factor for postoperative morbidity.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Active Comparator | Bowel preparation |
|
| 2 | Experimental | without bowel preparation |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| bowel preparation | Procedure | oral laxatives, retrograde enemas |
| |
| no preparation bowel |
| Measure | Description | Time Frame |
|---|---|---|
| Overall morbidity including infectious and non infectious complications | peri operative |
| Measure | Description | Time Frame |
|---|---|---|
| - peri operative mortality - non infectious morbidity - anastomotic leakage - hospital stay - per operative evaluation of bowel preparation - clinical evaluation of bowel preparation | 30 days, 6 months | |
| Evaluate the postoperative complications classified according to the DINDO classification. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| PANIS Yves, Pr | Assistance Publique - Hôpitaux de Paris | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| CHU | Angers | 49000 | France | |||
| Hopital Saint André |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 21037443 | Derived | Bretagnol F, Panis Y, Rullier E, Rouanet P, Berdah S, Dousset B, Portier G, Benoist S, Chipponi J, Vicaut E; French Research Group of Rectal Cancer Surgery (GRECCAR). Rectal cancer surgery with or without bowel preparation: The French GRECCAR III multicenter single-blinded randomized trial. Ann Surg. 2010 Nov;252(5):863-8. doi: 10.1097/SLA.0b013e3181fd8ea9. |
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| ID | Term |
|---|---|
| D012004 | Rectal Neoplasms |
| D057868 | Anastomotic Leak |
| ID | Term |
|---|---|
| D015179 | Colorectal Neoplasms |
| D007414 | Intestinal Neoplasms |
| D005770 | Gastrointestinal Neoplasms |
| D004067 | Digestive System Neoplasms |
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| ID | Term |
|---|---|
| D002400 | Cathartics |
| ID | Term |
|---|---|
| D005765 | Gastrointestinal Agents |
| D045506 | Therapeutic Uses |
| D020228 | Pharmacologic Actions |
| D020164 | Chemical Actions and Uses |
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| Procedure |
no preparation bowel |
|
| during the study |
| Bordeaux |
| 33075 |
| France |
| Hopital Ambroise Paré | Boulognes Billancourt | 92100 | France |
| CHU | Clermont-Ferrand | 63000 | France |
| Hôpital Beaujon | Clichy | 92110 | France |
| Hopital Nord | Marseille | 13000 | France |
| Institut Paoli Calmette | Marseille | 13273 | France |
| CRLC Val d'Aurelle | Montpellier | 34298 | France |
| Hopital Cochin | Paris | 75014 | France |
| CHU Purpan | Toulouse | 31059 | France |
| CHRU Trousseau | Tours | 37044 | France |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D004066 | Digestive System Diseases |
| D005767 | Gastrointestinal Diseases |
| D007410 | Intestinal Diseases |
| D012002 | Rectal Diseases |
| D011183 | Postoperative Complications |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |