Neoplasms

Digestive System Diseases

All Conditions

Rectal Neoplasms

Colorectal Neoplasms

Intestinal Neoplasms

Gastrointestinal Neoplasms

Digestive System Neoplasms

Gastrointestinal Diseases

Intestinal Diseases

Rectal Diseases

Micronutrients

All Drugs and Chemicals

Anti-Infective Agents

Gastrointestinal Agents

Vitamins

Ascorbic Acid

Anti-Bacterial Agents

Antibiotics, Antitubercular

Polyethylene glycol 3350

Sodium sulfate

Rifaximin

Vitamin C

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

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

Full bowel preparation

Mechanical bowel preparation only

Aleksei Karachun

Aleksei Petrov

Georgy Saakyan

Oleg Knyazev

Liliya Polishchuk

Fedor Vetshev

Tatiana Garmanova

Mikhail Agapov

Ivan Ignatov

Evgeniy Drozdov

Mikhail Postolov

Victoriya Zhavoronkova

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.

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.

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

We are not planning to share individual participant data

Rate of incisional SSI in patients after rectal resections

Rate of clinical and/or radiological anastomotic leaks

Rate of patients with any complications after surgery

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 Rectal Resections for Cancer Versus MBP Alone	NCT04592289	Rectal Cancer	Full bowel prep... Mechanical bowe...	18 Years -	N.N. Petrov National Medical Research Center of Oncology
Short-term Outcomes of Full Bowel Preparation (MBP+OA) for Rectal Resections for Cancer Versus MBP Alone	NCT04592289	Rectal Cancer	Full bowel prep... Mechanical bowe...	18 Years -	N.N. Petrov National Medical Research Center of Oncology

Spots Global Cancer Trial Database for mechanical bowel preparation only