Colon Cancer
Conditions
Keywords
colon cancer, MBP, bowel preparation, oral antibiotics
Brief summary
The purpose of the study is to determine if short-term outcomes of colon resections after full bowel preparation (mechanical bowel preparation plus oral antibiotics) are superior to colon resections with no bowel preparation.
Detailed description
The design involves random allocation of eligible patients to full bowel preparation or no bowel preparation in 1:1 ratio. After that colon 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 anastomotic leak is anticipated to decrease from 8% (data from local registry) to 3%. For power of 80% enrolment of 586 patients is required. The intent-to-treat principle is used for the data analysis.
Interventions
PROCEDUREFull bowel preparation prior to colon resection for cancer
Mechanical bowel preparation and oral antibiotics
PROCEDURENo bowel preparation
Omission of any bowel preparation
Sponsors
N.N. Petrov National Medical Research Center of Oncology
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* histologically confirmed adenocarcinoma of the colon (caecum, ascending, transverse, descending, sigmoid) * clinical stage T1-4aN0-2M0-1 (distant metastases must be resectable) * indications for surgical colonic resection * ECOG status 0-2 * At least 18 years of age * Written informed consent
Exclusion criteria
* Medical or psychiatric conditions that compromise the patient's ability to give informed consent or comply with the study protocol * Pregnancy or breast feeding * Medical contraindications for surgical treatment * Any use of antibiotics 30 days prior to inclusion * Functioning stoma * Contraindications for use of MBP or OA drugs or their components * Indications for mandatory MBP (planned intraoperative colonoscopy etc) * Indications for obstructive resection * Acute bowel obstruction, bleeding or perforation * Other malignancies not in remission
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Anastomotic leak rate | 30 days | Rate of anastomotic leak in patients after colon resections |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Intraabdominal and or pelvic abscess rate | 30 days | Rate of intraabdominal and or pelvic abscess |
| Overall morbidity | 30 days | Rate of patients with any complications after surgery |
| Rate of intraoperative complications | Duration of surgical procedure | Rate of patients with intraoperative complications |
| Surgical site infection (SSI) rate | 30 days | Rate of Surgical site infection |
| Quality of bowel preparation assessed by surgeon | Day of surgical procedure | Assessment of bowel preparation quality by surgeon (qualitative scale) |
| Bowel preparation compliance | Day of surgical procedure | Rate of patients in experimental arm undergoing complete bowel preparation according to protocol |
| Surgery duration in minutes | Duration of surgical procedure | Time of surgical procedure |
Countries
Russia
Contacts
Primary ContactAleksei Karachun
Backup ContactAleksei Petrov
Outcome results
None listed