Rectal Adenocarcinoma, Rectum Neoplasm, Rectum Carcinoma, Colorectal Cancer, Colorectal Neoplasms, Colorectal Carcinoma, Surgical Site Infection, Surgery--Complications
Conditions
Brief summary
MOBILE2 is a randomized controlled trial comparing mechanical and oral antibiotic bowel preparation to mechanical bowel preparation only in patients undergoing anterior rectal resection with primary anastomosis. Primary endpoint is Comprehensive Complication Index within 30 days from surgery.
Interventions
DRUGOral Antibiotics
Oral antibiotics (neomycin 1g and metronidazole 1g at 3pm and 11pm the day before surgery)
DRUGPlacebo
Oral placebos (placebo 1 and placebo 2 at 3pm and 11pm the day before surgery)
Mechanical Bowel Preparation using 2L polyethylene glycol (Moviprep)
Sponsors
Helsinki University Central Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Patients scheduled for anterior rectal resection with primary anastomosis
Exclusion criteria
* Emergency operation * Bowel obstruction * Existing stoma * Other reason preventing mechanical bowel preparation * Allergy to neomycin or metronidazole * Age \< 18 years * Lack of co-operation
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Comprehensive Complication Index | Within 30 days from surgery | Comprehensive Complication Index score |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Surgical Site Infection | Within 30 days from surgery | Surgical site infection as defined by CDC |
| Anastomotic dehiscence | Within 30 days from surgery | Anastomotic dehiscence |
| Lenght of hospital stay | Within hospital stay, estimated on average 7 days | Lenght of hospital stay |
| Mortality | Within 90 days from surgery | Mortality |
| Adjuvant therapy | Within 6 months from surgery | Patients receiving adjuvant therapy divided by patients needing adjuvant therapy |
Other
| Measure | Time frame | Description |
|---|---|---|
| Quality of life (LARS) | At randomization and at one year from surgery | Difference in quality of life between baseline and 1 year measured using LARS |
| 5-year overall survival | 5 years from surgery | 5-year overall survival |
| Bowel microbiota | Before, at, 6 months, and 1 year after surgery. | Bowel microbiota |
| Adverse effects of antibiotics | Within 30 days from surgery | Adverse effects of antibiotics |
| 5-year disease specific survival | 5 years from surgery | 5-year disease specific survival |
| 5-year recurrence free survival | 5 years from surgery | 5-year recurrence free survival |
| Quality of life (SF-36) | At randomization and at one year from surgery | Difference in quality of life between baseline and 1 year measured using SF-36 |
| Quality of life (QLQ-C30) | At randomization and at one year from surgery | Difference in quality of life between baseline and 1 year measured using QLQ-C30 |
| Quality of life (QLQ-CR29) | At randomization and at one year from surgery | Difference in quality of life between baseline and 1 year measured using QLQ-CR29 |
Countries
Finland
Outcome results
None listed