Neoplasms

Digestive System Diseases

All Conditions

Colonic Neoplasms

Colorectal Neoplasms

Intestinal Neoplasms

Gastrointestinal Neoplasms

Digestive System Neoplasms

Gastrointestinal Diseases

Colonic Diseases

Intestinal Diseases

Micronutrients

All Drugs and Chemicals

Anti-Infective Agents

Gastrointestinal Agents

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Ascorbic Acid

Anti-Bacterial Agents

Antibiotics, Antitubercular

Polyethylene glycol 3350

Rifaximin

Vitamin C

Cola

Rifaximin 400 mg twice daily for three days prior to surgery

Day prior to surgery:

17.00 - 18.00 Macrogol-3350 - 100 g Natrium sulfate - 7,5 g Natrium chloride - 2,691 g Potassium chloride - 1,015 g Ascorbic acid - 4,7 g Natrii ascorbate - 5,9 g Clear fluids - 1000 ml

18.00 - 19.00 Clear fluids 500 ml

19.00 - 20.00 Macrogol-3350 - 100 g Natrium sulfate - 7,5 g Natrium chloride - 2,691 g Potassium chloride - 1,015 g Ascorbic acid - 4,7 g Natrii ascorbate - 5,9 g Clear fluids - 1000 ml

20.00 - 21.00 Clear fluids 500 ml

No bowel preparation (enema of not more then 500 ml is allowed prior or during surgery)

Mechanical bowel preparation and oral antibiotics

Full bowel preparation prior to colon resection for cancer

No bowel preparation

Aleksei Karachun

Aleksei Petrov

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.

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.

Short-term Outcomes of Full Bowel Preparation (MBP+OA) for Colon Cancer Resections Versus no Bowel Preparation

Short-term Outcomes of Full Bowel Preparation (MBP+OA) for Colon Resections for Cancer Versus no Bowel Preparation

We are not planning to share individual participant data

Rate of anastomotic leak in patients after colon resections

Rate of intraabdominal and or pelvic abscess

Rate of patients with any complications after surgery

Rate of patients with intraoperative complications

Assessment of bowel preparation quality by surgeon (qualitative scale)

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

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization	Link
Short-term Outcomes of Full Bowel Preparation (MBP+OA) for Colon Cancer Resections Versus no Bowel Preparation	NCT05546892	Colon Cancer	Full bowel prep... No bowel prepar...	18 Years -	N.N. Petrov National Medical Research Center of Oncology
Short-term Outcomes of Full Bowel Preparation (MBP+OA) for Colon Cancer Resections Versus no Bowel Preparation	NCT05546892	Colon Cancer	Full bowel prep... No bowel prepar...	18 Years -	N.N. Petrov National Medical Research Center of Oncology

Spots Global Cancer Trial Database for full bowel preparation prior to colon resection for cancer