Short-term Outcomes of Full Bowel Preparation (MBP+OA) for Rectal Resections for Cancer Versus MBP Alone
Status: Recruiting
Location: See all (7) locations...
Intervention Type: Procedure
Study Type: Interventional
Study Phase: Not Applicable
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.
Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:
• 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
Locations
Other Locations
Russian Federation
GBUZ Moscow Clinical Scientific Center named after Loginov MHD
RECRUITING
Moscow
I.M. Sechenov First Moscow State Medical University, Clinic of Oncology, Radiotherapy and Reconstructive Surgery
RECRUITING
Moscow
Lomonosov Moscow State University Medical Research and Educational Center
RECRUITING
Moscow
Ryazan State Clinical Hospital
RECRUITING
Ryazan
Scientific-Research institute of Oncology named after N.N. Petrov
RECRUITING
Saint Petersburg
Tomsk Regional Oncology Hospital
RECRUITING
Tomsk
Volgograd State Medical University, Ministry of Health of Russia
RECRUITING
Volgograd
Contact Information
Primary
Aleksei Karachun
dr.a.karachun@gmail.com
+79219462123
Backup
Aleksei Petrov
alexpetrov@doctor.com
+79214117866
Time Frame
Start Date: 2020-10-30
Estimated Completion Date: 2024-08
Participants
Target number of participants: 622
Treatments
Experimental: Full bowel preparation (MBP+OA)
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
Active_comparator: Mechanical bowel preparation only
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
Related Therapeutic Areas
Sponsors
Leads: N.N. Petrov National Medical Research Center of Oncology