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Clinical Trial Details — Status: Active, not recruiting

Administrative data

NCT number NCT04281667
Other study ID # 14112018
Secondary ID
Status Active, not recruiting
Phase Phase 4
First received
Last updated
Start date March 18, 2020
Est. completion date October 10, 2027

Study information

Verified date November 2022
Source Helsinki University Central Hospital
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

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

Study Design


Intervention

Drug:
Oral Antibiotics
Oral antibiotics (neomycin 1g and metronidazole 1g at 3pm and 11pm the day before surgery)
Placebo
Oral placebos (placebo 1 and placebo 2 at 3pm and 11pm the day before surgery)
Mechanical Bowel Preparation
Mechanical Bowel Preparation using 2L polyethylene glycol (Moviprep)

Locations

Country Name City State
Finland Helsinki University Hospital Helsinki
Finland Tampere University Hospital Tampere
Finland Turku University Hospital Turku

Sponsors (1)

Lead Sponsor Collaborator
Helsinki University Central Hospital

Country where clinical trial is conducted

Finland, 

Outcome

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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