Mechanical Bowel Preparation and Oral Antibiotics Versus Mechanical Bowel Preparation Only Prior Rectal Surgery (MOBILE2)

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

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Colorectal Neoplasms; Colorectal Cancer; Surgery--Complications; Surgical Site Infection; Colorectal Carcinoma; Rectal Adenocarcinoma; Rectum Neoplasm; Rectum Carcinoma
• Intervention / Treatment: Drug: Oral Antibiotics; Drug: Mechanical Bowel Preparation; Drug: Placebo

• Study Type: Interventional
• Enrollment (Anticipated): 604
• Phase: Phase 4

Contacts and Locations

Study Locations

• Finland
  • Helsinki, Finland
    • Helsinki University Hospital
  • Tampere, Finland
    • Tampere University Hospital
  • Turku, Finland
    • Turku University Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: PREVENTION
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: QUADRUPLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: Mechanical Bowel Preparation and Oral Antibiotics	Drug: Oral Antibiotics; Oral antibiotics (neomycin 1g and metronidazole 1g at 3pm and 11pm the day before surgery); Drug: Mechanical Bowel Preparation; Mechanical Bowel Preparation using 2L polyethylene glycol (Moviprep)
ACTIVE_COMPARATOR: Mechanical Bowel Preparation Only	Drug: Mechanical Bowel Preparation; Mechanical Bowel Preparation using 2L polyethylene glycol (Moviprep); Drug: Placebo; Oral placebos (placebo 1 and placebo 2 at 3pm and 11pm the day before surgery)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Comprehensive Complication Index	Comprehensive Complication Index score	Within 30 days from surgery

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Surgical Site Infection	Surgical site infection as defined by CDC	Within 30 days from surgery
Anastomotic dehiscence	Anastomotic dehiscence	Within 30 days from surgery
Lenght of hospital stay	Lenght of hospital stay	Within hospital stay, estimated on average 7 days
Mortality	Mortality	Within 90 days from surgery
Adjuvant therapy	Patients receiving adjuvant therapy divided by patients needing adjuvant therapy	Within 6 months from surgery

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
5-year overall survival	5-year overall survival	5 years from surgery
5-year disease specific survival	5-year disease specific survival	5 years from surgery
5-year recurrence free survival	5-year recurrence free survival	5 years from surgery
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
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
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
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
Adverse effects of antibiotics	Adverse effects of antibiotics	Within 30 days from surgery
Bowel microbiota	Bowel microbiota	Before, at, 6 months, and 1 year after surgery.

Collaborators and Investigators

• Sponsor: Helsinki University Central Hospital
• Investigators: Principal Investigator: Laura Koskenvuo, MD, PhD, Helsinki University Central Hospital; Study Chair: Anna Lepistö, MD, PhD, Helsinki University Central Hospital

Publications and helpful links

General Publications

• Koskenvuo L, Lunkka P, Varpe P, Hyoty M, Satokari R, Haapamaki C, Lepisto A, Sallinen V. Mechanical bowel preparation and oral antibiotics versus mechanical bowel preparation only prior rectal surgery (MOBILE2): a multicentre, double-blinded, randomised controlled trial-study protocol. BMJ Open. 2021 Jul 9;11(7):e051269. doi: 10.1136/bmjopen-2021-051269.
• Koskenvuo L, Sallinen V. Preoperative oral antibiotics in colon surgery. Lancet Gastroenterol Hepatol. 2020 Sep;5(9):801-802. doi: 10.1016/S2468-1253(20)30203-X. No abstract available.

Study record dates

Study Major Dates

• Study Start (ACTUAL): March 18, 2020
• Primary Completion (ACTUAL): November 9, 2022
• Study Completion (ANTICIPATED): October 10, 2027

Study Registration Dates

• First Submitted: February 14, 2020
• First Submitted That Met QC Criteria: February 21, 2020
• First Posted (ACTUAL): February 24, 2020

Study Record Updates

• Last Update Posted (ACTUAL): November 17, 2022
• Last Update Submitted That Met QC Criteria: November 16, 2022
• Last Verified: November 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; Pathologic Processes; Infections; Neoplasms by Histologic Type; Neoplasms by Site; Neoplasms, Glandular and Epithelial; Postoperative Complications; Gastrointestinal Neoplasms; Digestive System Neoplasms; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Intestinal Neoplasms; Rectal Diseases; Wound Infection; Neoplasms; Carcinoma; Colorectal Neoplasms; Rectal Neoplasms; Surgical Wound Infection; Anti-Infective Agents; Anti-Bacterial Agents
• Other Study ID Numbers: 14112018

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: Individual deidentified participant data will not be available for sharing. Study protocol will be available.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No