Colorectal Cancer Clinical Trial
— MOBILE2Official title:
Mechanical Bowel Preparation and Oral Antibiotics Versus Mechanical Bowel Preparation Only Prior Rectal Surgery - a Prospective, Randomized Controlled Trial
Verified date | November 2022 |
Source | Helsinki University Central Hospital |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Active, not recruiting |
Enrollment | 604 |
Est. completion date | October 10, 2027 |
Est. primary completion date | November 9, 2022 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | 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 Exclusion criteria after randomization: - Patient did not undergo surgery - Anterior resection was not performed - Colonic anastomosis was not performed |
Country | Name | City | State |
---|---|---|---|
Finland | Helsinki University Hospital | Helsinki | |
Finland | Tampere University Hospital | Tampere | |
Finland | Turku University Hospital | Turku |
Lead Sponsor | Collaborator |
---|---|
Helsinki University Central Hospital |
Finland,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Other | 5-year overall survival | 5-year overall survival | 5 years from surgery | |
Other | 5-year disease specific survival | 5-year disease specific survival | 5 years from surgery | |
Other | 5-year recurrence free survival | 5-year recurrence free survival | 5 years from surgery | |
Other | Quality of life (SF-36) | Difference in quality of life between baseline and 1 year measured using SF-36 | At randomization and at one year from surgery | |
Other | Quality of life (QLQ-C30) | Difference in quality of life between baseline and 1 year measured using QLQ-C30 | At randomization and at one year from surgery | |
Other | Quality of life (QLQ-CR29) | Difference in quality of life between baseline and 1 year measured using QLQ-CR29 | At randomization and at one year from surgery | |
Other | Quality of life (LARS) | Difference in quality of life between baseline and 1 year measured using LARS | At randomization and at one year from surgery | |
Other | Adverse effects of antibiotics | Adverse effects of antibiotics | Within 30 days from surgery | |
Other | Bowel microbiota | Bowel microbiota | Before, at, 6 months, and 1 year after surgery. | |
Primary | Comprehensive Complication Index | Comprehensive Complication Index score | Within 30 days from surgery | |
Secondary | Surgical Site Infection | Surgical site infection as defined by CDC | Within 30 days from surgery | |
Secondary | Anastomotic dehiscence | Anastomotic dehiscence | Within 30 days from surgery | |
Secondary | Lenght of hospital stay | Lenght of hospital stay | Within hospital stay, estimated on average 7 days | |
Secondary | Mortality | Mortality | Within 90 days from surgery | |
Secondary | Adjuvant therapy | Patients receiving adjuvant therapy divided by patients needing adjuvant therapy | Within 6 months from surgery |
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