bowel preparation
Procedureoral laxatives, retrograde enemas
NCT Number: NCT00554892
The aim of this controlled multicentric study is to assess rectal cancer surgery with sphincter preservation without pre operative mechanical bowel preparation
Looking for future studies?
Notify Me18 year and older
All sexes
Interventional
Not applicable
CHU, Angers, France
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
oral laxatives, retrograde enemas
no preparation bowel
Time frame: peri operative
Time frame: 30 days, 6 months
Time frame: during the study
Assistance Publique - Hôpitaux de Paris
Other
ClinicalTrial in Rectal Cancer Surgery Without Mechanical Bowel Preparation
Acronym: PREPACOL
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
Published trials that share one or more normalized conditions with this study.
NCT07725692
Anastomotic Leak, Colon Cancer
Alexandria, Please Select, Egypt
View Trial DetailsNCT06204497
Anastomotic Leak, Colorectal Neoplasms
Beijing, Beijing Municipality, China
View Trial DetailsNCT01999634
Anastomotic Leak, Colorectal Neoplasms
Amiens, France
View Trial DetailsNCT05667181
Anastomotic Leak, Colorectal Neoplasms
Nanchang, Jiangxi, China
View Trial Details