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

Rectal Cancer Clinical Trial

— REPCA  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04592289
• Other study ID #: COL-3
• Status: Recruiting
• Phase: N/A
• Start date: October 30, 2020
• Est. completion date: August 2024

Study information

• Verified date: November 2023
• Source: N.N. Petrov National Medical Research Center of Oncology
• Contact: Aleksei Karachun
• Phone: +79219462123
• Email: dr.a.karachun[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 622
• Est. completion date: August 2024
• Est. primary completion date: August 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Rectal Cancer
• Rectal Neoplasms

Intervention

Procedure:
• Full bowel preparation
MBP+OA
• Mechanical bowel preparation only
MBP

Locations

Country	Name	City	State
Russian Federation	GBUZ Moscow Clinical Scientific Center named after Loginov MHD	Moscow
Russian Federation	I.M. Sechenov First Moscow State Medical University, Clinic of Oncology, Radiotherapy and Reconstructive Surgery	Moscow
Russian Federation	Lomonosov Moscow State University Medical Research and Educational Center	Moscow
Russian Federation	Ryazan State Clinical Hospital	Ryazan
Russian Federation	Scientific-Research institute of Oncology named after N.N. Petrov	Saint Petersburg
Russian Federation	Tomsk Regional Oncology Hospital	Tomsk
Russian Federation	Volgograd State Medical University, Ministry of Health of Russia	Volgograd

Sponsors (1)

Lead Sponsor	Collaborator
N.N. Petrov National Medical Research Center of Oncology

Country where clinical trial is conducted

Russian Federation, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Incisional surgical site infection (SSI) rate	Rate of incisional SSI in patients after rectal resections	30 days
Secondary	Anastomotic leak rate	Rate of clinical and/or radiological anastomotic leaks	30 days
Secondary	Intraabdominal and or pelvic abscess rate		30 days
Secondary	Overall morbidity	Rate of patients with any complications after surgery	30 days
Secondary	Rate of intraoperative complications		Duration of surgical procedure
Secondary	Surgery duration in minutes		Duration of surgical procedure
Secondary	Quality of bowel preparation assessed by surgeon	Assessment of bowel preparation quality by surgeon (qualitative scale)	Day of surgery
Secondary	Bowel preparation compliance	Rate of patients in experimental arm undergoing complete bowel preparation according to protocol	Day of surgery