Clinical trial NCT05546892: Short-term Outcomes of Full Bowel Preparation (MBP+OA) for Colon Cancer Resections Versus no Bowel Preparation
Official title: Short-term Outcomes of Full Bowel Preparation (MBP+OA) for Colon Resections for Cancer Versus no Bowel Preparation
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Colon Cancer
Keywords: colon cancer
MBP
bowel preparation
oral antibiotics
Lead sponsor: N.N. Petrov National Medical Research Center of Oncology
Sponsor class: OTHER
First posted: 2022-09-21
Enrollment: 586
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: Anastomotic leak rate
timeFrame: 30 days
Secondary outcomes:
measure: Surgical site infection (SSI) rate
timeFrame: 30 days
measure: Intraabdominal and or pelvic abscess rate
timeFrame: 30 days
measure: Overall morbidity
timeFrame: 30 days
measure: Rate of intraoperative complications
timeFrame: Duration of surgical procedure
measure: Surgery duration in minutes
timeFrame: Duration of surgical procedure
measure: Quality of bowel preparation assessed by surgeon
timeFrame: Day of surgical procedure
measure: Bowel preparation compliance
timeFrame: Day of surgical procedure
Other outcomes:
Locations:
city: Saint Petersburg
country: Russian Federation
facility: N.N. Petrov National Medical Research Center of Oncology
Study officials:
affiliation: N.N. Petrov National Medical Research Center of Oncology
name: Aleksei Karachun
role: STUDY_CHAIR
References: