Short-term Outcomes of Full Bowel Preparation (MBP+OA) for Rectal Resections for Cancer Versus MBP Alone (REPCA)

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.

Study Overview

• Status: Recruiting
• Conditions: Rectal Cancer
• Intervention / Treatment: Procedure: Full bowel preparation; Procedure: Mechanical bowel preparation only

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.

• Study Type: Interventional
• Enrollment (Estimated): 622
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Aleksei Karachun; Phone Number: +79219462123; Email: dr.a.karachun@gmail.com
• Study Contact Backup: Name: Aleksei Petrov; Phone Number: +79214117866; Email: alexpetrov@doctor.com

Study Locations

• Russian Federation
  • Moscow, Russian Federation
    • Recruiting
    • GBUZ Moscow Clinical Scientific Center named after Loginov MHD
    • Contact: Georgy Saakyan; Phone Number: +79629532211; Email: G.saakian@mknc.ru
    • Principal Investigator: Oleg Knyazev
    • Sub-Investigator: Georgy Saakyan
  • Moscow, Russian Federation
    • Recruiting
    • I.M. Sechenov First Moscow State Medical University, Clinic of Oncology, Radiotherapy and Reconstructive Surgery
    • Contact: Liliya Polishchuk; Phone Number: +79166349069; Email: polishchuk13@gmail.com
    • Principal Investigator: Fedor Vetshev
    • Sub-Investigator: Liliya Polishchuk
  • Moscow, Russian Federation
    • Recruiting
    • Lomonosov Moscow State University Medical Research and Educational Center
    • Contact: Tatiana Garmanova; Phone Number: +79773429249; Email: Tatianagarmanova@gmail.com
    • Principal Investigator: Mikhail Agapov
    • Sub-Investigator: Tatiana Garmanova
  • Ryazan, Russian Federation
    • Recruiting
    • Ryazan State Clinical Hospital
    • Contact: Ivan Ignatov; Phone Number: +79065440152; Email: ignatov.mac93@mail.ru
    • Principal Investigator: Ivan Ignatov
  • Saint Petersburg, Russian Federation, 197758
    • Recruiting
    • Scientific-Research institute of Oncology named after N.N. Petrov
    • Contact: Aleksei Petrov; Phone Number: +79214117866; Email: alexpetrov@doctor.com
    • Principal Investigator: Aleksei Karachun
    • Sub-Investigator: Aleksei Petrov
  • Tomsk, Russian Federation
    • Recruiting
    • Tomsk Regional Oncology Hospital
    • Contact: Evgeniy Drozdov; Phone Number: +79234186405; Email: e.s.drozdov@tomonco.ru
    • Principal Investigator: Evgeniy Drozdov
  • Volgograd, Russian Federation
    • Recruiting
    • Volgograd State Medical University, Ministry of Health of Russia
    • Contact: Mikhail Postolov; Phone Number: +79093845833; Email: 1postolov1@mail.ru
    • Principal Investigator: Victoriya Zhavoronkova
    • Sub-Investigator: Mikhail Postolov

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Full bowel preparation (MBP+OA); Rifaximin 400 mg twice daily for three days prior to surgery Day prior to surgery: 17.00 - 18.00 Macrogol-3350 - 100 g Sodium sulfate - 7,5 g Sodium chloride - 2,691 g Potassium chloride - 1,015 g Ascorbic acid - 4,7 g Sodium ascorbate - 5,9 g Clear fluids - 1000 ml 18.00 - 19.00 Clear fluids 500 ml 19.00 - 20.00 17.00 - 18.00 Macrogol-3350 - 100 g Sodium sulfate - 7,5 g Sodium chloride - 2,691 g Potassium chloride - 1,015 g Ascorbic acid - 4,7 g Sodium ascorbate - 5,9 g Clear fluids - 1000 ml 20.00 - 21.00 Clear fluids 500 ml	Procedure: Full bowel preparation; MBP+OA
Active Comparator: Mechanical bowel preparation only; Day prior to surgery: 17.00 - 18.00 Macrogol-3350 - 100 g Sodium sulfate - 7,5 g Sodium chloride - 2,691 g Potassium chloride - 1,015 g Ascorbic acid - 4,7 g Sodium ascorbate - 5,9 g Clear fluids - 1000 ml 18.00 - 19.00 Clear fluids 500 ml 19.00 - 20.00 Macrogol-3350 - 100 g Sodium sulfate - 7,5 g Sodium chloride - 2,691 g Potassium chloride - 1,015 g Ascorbic acid - 4,7 g Sodium ascorbate - 5,9 g Clear fluids - 1000 ml 20.00 - 21.00 Clear fluids 500 ml	Procedure: Mechanical bowel preparation only; MBP

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Incisional surgical site infection (SSI) rate	Rate of incisional SSI in patients after rectal resections	30 days

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Anastomotic leak rate	Rate of clinical and/or radiological anastomotic leaks	30 days
Intraabdominal and or pelvic abscess rate		30 days
Overall morbidity	Rate of patients with any complications after surgery	30 days
Rate of intraoperative complications		Duration of surgical procedure
Surgery duration in minutes		Duration of surgical procedure
Quality of bowel preparation assessed by surgeon	Assessment of bowel preparation quality by surgeon (qualitative scale)	Day of surgery
Bowel preparation compliance	Rate of patients in experimental arm undergoing complete bowel preparation according to protocol	Day of surgery

Collaborators and Investigators

• Sponsor: N.N. Petrov National Medical Research Center of Oncology
• Investigators: Study Chair: Aleksei Karachun, National Medical Research Centre of Oncology named after N.N. Petrov

Study record dates

Study Major Dates

• Study Start (Actual): October 30, 2020
• Primary Completion (Estimated): August 1, 2024
• Study Completion (Estimated): August 1, 2024

Study Registration Dates

• First Submitted: October 12, 2020
• First Submitted That Met QC Criteria: October 12, 2020
• First Posted (Actual): October 19, 2020

Study Record Updates

• Last Update Posted (Estimated): November 17, 2023
• Last Update Submitted That Met QC Criteria: November 16, 2023
• Last Verified: November 1, 2023

More Information

Terms related to this study

• Keywords: rectal cancer; bowel preparation; Oral antibiotics; MBP
• Additional Relevant MeSH Terms: Digestive System Diseases; Neoplasms; Neoplasms by Site; Gastrointestinal Neoplasms; Digestive System Neoplasms; Gastrointestinal Diseases; Intestinal Diseases; Intestinal Neoplasms; Rectal Diseases; Colorectal Neoplasms; Rectal Neoplasms
• Other Study ID Numbers: COL-3

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: We are not planning to share individual participant data

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No