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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.
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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 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 |
|
| Mechanical bowel preparation only | Active Comparator | 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 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Full bowel preparation | Procedure | MBP+OA |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Incisional surgical site infection (SSI) rate | Rate of incisional SSI in patients after rectal resections | 30 days |
| Measure | Description | Time Frame |
|---|---|---|
| Anastomotic leak rate | Rate of clinical and/or radiological anastomotic leaks | 30 days |
| Intraabdominal and or pelvic abscess rate | 30 days |
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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 | National Medical Research Centre of Oncology named after N.N. Petrov | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| GBUZ Moscow Clinical Scientific Center named after Loginov MHD | Recruiting | Moscow | Russia |
We are not planning to share individual participant data
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| Mechanical bowel preparation only |
| Procedure |
MBP |
|
| Overall morbidity | Rate of patients with any complications after surgery | 30 days |
| Rate of intraoperative complications | Duration of surgical procedure |
| Surgery duration in minutes | Duration of surgical procedure |
| Quality of bowel preparation assessed by surgeon | Assessment of bowel preparation quality by surgeon (qualitative scale) | Day of surgery |
| Bowel preparation compliance | Rate of patients in experimental arm undergoing complete bowel preparation according to protocol | Day of surgery |
| I.M. Sechenov First Moscow State Medical University, Clinic of Oncology, Radiotherapy and Reconstructive Surgery | Recruiting | Moscow | Russia |
|
| Lomonosov Moscow State University Medical Research and Educational Center | Recruiting | Moscow | Russia |
|
| Ryazan State Clinical Hospital | Recruiting | Ryazan | Russia |
|
| Scientific-Research institute of Oncology named after N.N. Petrov | Recruiting | Saint Petersburg | 197758 | Russia |
|
| Tomsk Regional Oncology Hospital | Recruiting | Tomsk | Russia |
|
| Volgograd State Medical University, Ministry of Health of Russia | Recruiting | Volgograd | Russia |
|
| ID | Term |
|---|---|
| D012004 | Rectal 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 |
| D007410 | Intestinal Diseases |
| D012002 | Rectal Diseases |
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