Spots Global Cancer Trial Database for Short-term Outcomes of Full Bowel Preparation (MBP+OA) for Rectal Resections for Cancer Versus MBP Alone
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Trial Identification
Brief Title: Short-term Outcomes of Full Bowel Preparation (MBP+OA) for Rectal Resections for Cancer Versus MBP Alone
Official Title: Short-term Outcomes of Full Bowel Preparation (MBP+OA) for Rectal Resections for Cancer Versus MBP Alone
Study ID: NCT04592289
Conditions
Study Description
Brief Summary: The purpose of the study is to determine if short-term outcomes of rectal resections after full bowel preparation (mechanical bowel preparation plus oral antibiotics) are superior to rectal resections with only mechanical bowel preparation.
Detailed Description: The design involves random allocation of eligible patients to full bowel preparation or only mechanical bowel preparation in 1:1 ratio. After that rectal resection is performed in both groups. Short-term outcomes are assessed in 30 day period after surgery. This is a superiority trial evaluating statistical superiority. Rate of surgical site infection is anticipated to decrease from 12% (data from local registry) to 6%. For power of 80% enrolment of 622 patients is required. The intent-to-treat principle is used for the data analysis.
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Locations
GBUZ Moscow Clinical Scientific Center named after Loginov MHD, Moscow, , Russian Federation
I.M. Sechenov First Moscow State Medical University, Clinic of Oncology, Radiotherapy and Reconstructive Surgery, Moscow, , Russian Federation
Lomonosov Moscow State University Medical Research and Educational Center, Moscow, , Russian Federation
Ryazan State Clinical Hospital, Ryazan, , Russian Federation
Scientific-Research institute of Oncology named after N.N. Petrov, Saint Petersburg, , Russian Federation
Tomsk Regional Oncology Hospital, Tomsk, , Russian Federation
Volgograd State Medical University, Ministry of Health of Russia, Volgograd, , Russian Federation
Contact Details
Name: Aleksei Karachun
Affiliation: National Medical Research Centre of Oncology named after N.N. Petrov
Role: STUDY_CHAIR
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