Rectal Cancer
Conditions
Keywords
rectal cancer, bowel preparation, MBP, Oral antibiotics
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.
Interventions
PROCEDUREFull bowel preparation
MBP+OA
PROCEDUREMechanical bowel preparation only
MBP
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 rectum or rectosigmoid junction * clinical stage T1-4aN0-2M0-1 (distant metastases must be resectable) * indications for surgical rectal 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 obstructive resection or abdominoperineal excision * Acute bowel obstruction, bleeding or perforation * Other malignancies not in remission
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Incisional surgical site infection (SSI) rate | 30 days | Rate of incisional SSI in patients after rectal resections |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Intraabdominal and or pelvic abscess rate | 30 days | — |
| Overall morbidity | 30 days | Rate of patients with any complications after surgery |
| Rate of intraoperative complications | Duration of surgical procedure | — |
| Anastomotic leak rate | 30 days | Rate of clinical and/or radiological anastomotic leaks |
| Quality of bowel preparation assessed by surgeon | Day of surgery | Assessment of bowel preparation quality by surgeon (qualitative scale) |
| Bowel preparation compliance | Day of surgery | Rate of patients in experimental arm undergoing complete bowel preparation according to protocol |
| Surgery duration in minutes | Duration of surgical procedure | — |
Countries
Russia
Contacts
Primary ContactAleksei Karachun
Backup ContactAleksei Petrov
Outcome results
None listed