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

• Sponsor: N.N. Petrov National Medical Research Center of Oncology (Other)
• Overall Status: Recruiting
• CT.gov ID: NCT04592289
• Collaborator: (none)
• Enrollment: 622
• Location: 1
• Arms: 2
• Anticipated Duration (Months): 33
• Patients Per Site Per Month: 18.8

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Rectal Cancer	Procedure: Full bowel preparation; Procedure: Mechanical bowel preparation only	N/A

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 Design

• Study Type: Interventional
• Anticipated Enrollment: 622 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: Short-term Outcomes of Full Bowel Preparation (MBP+OA) for Rectal Resections for Cancer Versus MBP Alone
• Actual Study Start Date: Oct 30, 2020
• Anticipated Primary Completion Date: Aug 1, 2023
• Anticipated Study Completion Date: Aug 1, 2023

Arms and Interventions

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 Clear fluids - 1000 ml 18.00 - 19.00 Clear fluids 500 ml 19.00 - 20.00 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 Clear fluids - 1000 ml 18.00 - 19.00 Clear fluids 500 ml 19.00 - 20.00 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

Outcome Measures

Primary Outcome Measures

1. Incisional surgical site infection (SSI) rate [30 days]

   Rate of incisional SSI in patients after rectal resections

Secondary Outcome Measures

1. Anastomotic leak rate [30 days]

   Rate of clinical and/or radiological anastomotic leaks

2. Intraabdominal and or pelvic abscess rate [30 days]

3. Overall morbidity [30 days]

   Rate of patients with any complications after surgery

4. Rate of intraoperative complications [Duration of surgical procedure]

5. Surgery duration in minutes [Duration of surgical procedure]

6. Quality of surgery [Day of surgery]

   Assessment of procedure quality by surgeon (qualitative scale)

7. Bowel preparation compliance [Day of surgery]

   Rate of patients in experimental arm undergoing complete bowel preparation according to protocol

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Scientific-Research institute of Oncology named after N.N. Petrov	Saint Petersburg		Russian Federation	197758

Sponsors and Collaborators

• 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 Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: N.N. Petrov National Medical Research Center of Oncology
• ClinicalTrials.gov Identifier: NCT04592289
• Other Study ID Numbers: COL-3
• First Posted: Oct 19, 2020
• Last Update Posted: Apr 21, 2022
• Last Verified: Apr 1, 2022

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by N.N. Petrov National Medical Research Center of Oncology: rectal cancer; bowel preparation; MBP; Oral antibiotics
• Additional relevant MeSH terms: Rectal Neoplasms

Study Results

No Results Posted as of Apr 21, 2022