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

Phase 4

Active, not recruiting

• Conditions: Rectal Adenocarcinoma; Rectum Neoplasm; Colorectal Neoplasms; Rectum Carcinoma; Colorectal Cancer; Colorectal Carcinoma; Surgical Site Infection; Surgery--Complications
• Interventions: Drug: Oral Antibiotics; Drug: Placebo; Drug: Mechanical Bowel Preparation

• Registration Number: NCT04281667
• Lead Sponsor: Helsinki University Central Hospital

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2020-02-14
• Study First Submitted QC: 2020-02-21
• Study First Posted: 2020-02-24
• Study Start: 2020-03-18
• Status Verified: 2022-11
• Primary Completion: 2022-11-09
• Last Update Submitted: 2022-11-16
• Last Update Posted: 2022-11-17
• Study Completion: 2027-10-10

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 604

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Mechanical Bowel Preparation and Oral Antibiotics	Oral Antibiotics	Mechanical Bowel Preparation and Oral Antibiotics
Mechanical Bowel Preparation and Oral Antibiotics	Mechanical Bowel Preparation	Mechanical Bowel Preparation and Oral Antibiotics
Mechanical Bowel Preparation Only	Placebo	Mechanical Bowel Preparation Only
Mechanical Bowel Preparation Only	Mechanical Bowel Preparation	Mechanical Bowel Preparation Only

Primary Outcome Measures

Name	Time	Method
Comprehensive Complication Index	Within 30 days from surgery	Comprehensive Complication Index score

Secondary Outcome Measures

Name	Time	Method
Surgical Site Infection	Within 30 days from surgery	Surgical site infection as defined by CDC
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
Anastomotic dehiscence	Within 30 days from surgery	Anastomotic dehiscence

Trial Locations

Locations (3)

Turku University Hospital; 🇫🇮 Turku, Finland

Helsinki University Hospital; 🇫🇮 Helsinki, Finland

Tampere University Hospital; 🇫🇮 Tampere, Finland