Mechanical Bowel Preparation and Oral Antibiotics Versus Mechanical Bowel Preparation Only Prior Rectal Surgery

Colorectal Cancer Clinical Trial

— MOBILE2  

Official title:

Mechanical Bowel Preparation and Oral Antibiotics Versus Mechanical Bowel Preparation Only Prior Rectal Surgery - a Prospective, Randomized Controlled Trial

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT04281667
• Other study ID #: 14112018
• Status: Active, not recruiting
• Phase: Phase 4
• 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
• 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

Related Conditions & MeSH terms

• Carcinoma
• Colorectal Cancer
• Colorectal Carcinoma
• Colorectal Neoplasms
• Neoplasms
• Rectal Adenocarcinoma
• Rectal Neoplasms
• Rectum Carcinoma
• Rectum Neoplasm
• Surgery--Complications
• Surgical Site Infection
• Surgical Wound Infection

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