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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Full bowel preparation (MBP+OA) | Experimental | 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 | Active Comparator | No bowel preparation (enema of not more then 500 ml is allowed prior or during surgery) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Full bowel preparation prior to colon resection for cancer | Procedure | Mechanical bowel preparation and oral antibiotics |
|
| Measure | Description | Time Frame |
|---|---|---|
| Anastomotic leak rate | Rate of anastomotic leak in patients after colon resections | 30 days |
| Measure | Description | Time Frame |
|---|---|---|
| Surgical site infection (SSI) rate | Rate of Surgical site infection | 30 days |
| Intraabdominal and or pelvic abscess rate | Rate of intraabdominal and or pelvic abscess |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Aleksei Karachun | Contact | +79219462123 | dr.a.karachun@gmail.com | |
| Aleksei Petrov | Contact | +79214117866 | alexpetrov@doctor.com |
| Name | Affiliation | Role |
|---|---|---|
| Aleksei Karachun | N.N. Petrov National Medical Research Center of Oncology | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| N.N. Petrov National Medical Research Center of Oncology | Recruiting | Saint Petersburg | 197758 | Russia |
We are not planning to share individual participant data
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| No bowel preparation | Procedure | Omission of any bowel preparation |
|
| 30 days |
| Overall morbidity | Rate of patients with any complications after surgery | 30 days |
| Rate of intraoperative complications | Rate of patients with intraoperative complications | Duration of surgical procedure |
| Surgery duration in minutes | Time of surgical procedure | Duration of surgical procedure |
| Quality of bowel preparation assessed by surgeon | Assessment of bowel preparation quality by surgeon (qualitative scale) | Day of surgical procedure |
| Bowel preparation compliance | Rate of patients in experimental arm undergoing complete bowel preparation according to protocol | Day of surgical procedure |
| ID | Term |
|---|---|
| D003110 | Colonic Neoplasms |
| ID | Term |
|---|---|
| D015179 | Colorectal Neoplasms |
| D007414 | Intestinal Neoplasms |
| D005770 | Gastrointestinal Neoplasms |
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D004066 | Digestive System Diseases |
| D005767 | Gastrointestinal Diseases |
| D003108 | Colonic Diseases |
| D007410 | Intestinal Diseases |
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