Clinical trial NCT04592289: 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 type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Rectal Cancer
Keywords: rectal cancer
bowel preparation
MBP
Oral antibiotics
Lead sponsor: N.N. Petrov National Medical Research Center of Oncology
Sponsor class: OTHER
First posted: 2020-10-19
Enrollment: 622
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 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 criteria: 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

Primary outcomes:
measure: Incisional surgical site infection (SSI) rate
timeFrame: 30 days
Secondary outcomes:
measure: Anastomotic leak 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 surgery
measure: Bowel preparation compliance
timeFrame: Day of surgery
Other outcomes:
Locations:
city: Moscow
country: Russian Federation
facility: GBUZ Moscow Clinical Scientific Center named after Loginov MHD
city: Moscow
country: Russian Federation
facility: I.M. Sechenov First Moscow State Medical University, Clinic of Oncology, Radiotherapy and Reconstructive Surgery
city: Moscow
country: Russian Federation
facility: Lomonosov Moscow State University Medical Research and Educational Center
city: Ryazan
country: Russian Federation
facility: Ryazan State Clinical Hospital
city: Saint Petersburg
country: Russian Federation
facility: Scientific-Research institute of Oncology named after N.N. Petrov
city: Tomsk
country: Russian Federation
facility: Tomsk Regional Oncology Hospital
city: Volgograd
country: Russian Federation
facility: Volgograd State Medical University, Ministry of Health of Russia
Study officials:
affiliation: National Medical Research Centre of Oncology named after N.N. Petrov
name: Aleksei Karachun
role: STUDY_CHAIR
References: