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

Primary Purpose

Rectal Adenocarcinoma, Rectum Neoplasm, Rectum Carcinoma

Status

Active

Phase

Phase 4

Locations

Finland

Study Type

Interventional

Intervention

Oral Antibiotics

Placebo

Mechanical Bowel Preparation

About this trial

This is an interventional prevention trial for Rectal Adenocarcinoma

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Helsinki University Hospital
Tampere University Hospital
Turku University Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Mechanical Bowel Preparation and Oral Antibiotics

Mechanical Bowel Preparation Only

Arm Description

Mechanical Bowel Preparation and Oral Antibiotics

Mechanical Bowel Preparation Only

Outcomes

Primary Outcome Measures

Comprehensive Complication Index

Comprehensive Complication Index score

Secondary Outcome Measures

Surgical Site Infection

Surgical site infection as defined by CDC

Anastomotic dehiscence

Lenght of hospital stay

Mortality

Adjuvant therapy

Patients receiving adjuvant therapy divided by patients needing adjuvant therapy

Full Information

NCT ID

NCT04281667

First Posted

February 14, 2020

Last Updated

November 16, 2022

Sponsor

Helsinki University Central Hospital

1. Study Identification

Unique Protocol Identification Number

NCT04281667

Brief Title

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

Acronym

MOBILE2

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

November 2022

Overall Recruitment Status

Active, not recruiting

Study Start Date

March 18, 2020 (Actual)

Primary Completion Date

November 9, 2022 (Actual)

Study Completion Date

October 10, 2027 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Helsinki University Central Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

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

7. Study Design

Primary Purpose

Prevention

Study Phase

Phase 4

Interventional Study Model

Parallel Assignment

Masking

ParticipantCare ProviderInvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

604 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Mechanical Bowel Preparation and Oral Antibiotics

Arm Type

Experimental

Arm Description

Mechanical Bowel Preparation and Oral Antibiotics

Arm Title

Mechanical Bowel Preparation Only

Arm Type

Active Comparator

Arm Description

Mechanical Bowel Preparation Only

Intervention Type

Drug

Intervention Name(s)

Oral Antibiotics

Intervention Description

Oral antibiotics (neomycin 1g and metronidazole 1g at 3pm and 11pm the day before surgery)

Intervention Type

Drug

Intervention Name(s)

Placebo

Intervention Description

Oral placebos (placebo 1 and placebo 2 at 3pm and 11pm the day before surgery)

Intervention Type

Drug

Intervention Name(s)

Mechanical Bowel Preparation

Intervention Description

Mechanical Bowel Preparation using 2L polyethylene glycol (Moviprep)

Primary Outcome Measure Information:

Title

Comprehensive Complication Index

Description

Comprehensive Complication Index score

Time Frame

Within 30 days from surgery

Secondary Outcome Measure Information:

Title

Surgical Site Infection

Description

Surgical site infection as defined by CDC

Time Frame

Within 30 days from surgery

Title

Anastomotic dehiscence

Description

Anastomotic dehiscence

Time Frame

Within 30 days from surgery

Title

Lenght of hospital stay

Description

Lenght of hospital stay

Time Frame

Within hospital stay, estimated on average 7 days

Title

Mortality

Description

Mortality

Time Frame

Within 90 days from surgery

Title

Adjuvant therapy

Description

Patients receiving adjuvant therapy divided by patients needing adjuvant therapy

Time Frame

Within 6 months from surgery

Other Pre-specified Outcome Measures:

Title

5-year overall survival

Description

5-year overall survival

Time Frame

5 years from surgery

Title

5-year disease specific survival

Description

5-year disease specific survival

Time Frame

5 years from surgery

Title

5-year recurrence free survival

Description

5-year recurrence free survival

Time Frame

5 years from surgery

Title

Quality of life (SF-36)

Description

Difference in quality of life between baseline and 1 year measured using SF-36

Time Frame

At randomization and at one year from surgery

Title

Quality of life (QLQ-C30)

Description

Difference in quality of life between baseline and 1 year measured using QLQ-C30

Time Frame

At randomization and at one year from surgery

Title

Quality of life (QLQ-CR29)

Description

Difference in quality of life between baseline and 1 year measured using QLQ-CR29

Time Frame

At randomization and at one year from surgery

Title

Quality of life (LARS)

Description

Difference in quality of life between baseline and 1 year measured using LARS

Time Frame

At randomization and at one year from surgery

Title

Adverse effects of antibiotics

Description

Adverse effects of antibiotics

Time Frame

Within 30 days from surgery

Title

Bowel microbiota

Description

Bowel microbiota

Time Frame

Before, at, 6 months, and 1 year after surgery.

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Laura Koskenvuo, MD, PhD

Organizational Affiliation

Helsinki University Central Hospital

Official's Role

Principal Investigator

First Name & Middle Initial & Last Name & Degree

Anna Lepistö, MD, PhD

Organizational Affiliation

Helsinki University Central Hospital

Official's Role

Study Chair

First Name & Middle Initial & Last Name & Degree

Ville Sallinen, MD, PhD

Organizational Affiliation

Helsinki University Central Hospital

Official's Role

Study Director

Facility Information:

Facility Name

Helsinki University Hospital

City

Helsinki

Country

Finland

Facility Name

Tampere University Hospital

City

Tampere

Country

Finland

Facility Name

Turku University Hospital

City

Turku

Country

Finland

12. IPD Sharing Statement

Plan to Share IPD

IPD Sharing Plan Description

Individual deidentified participant data will not be available for sharing. Study protocol will be available.

Citations:

PubMed Identifier

34244284

Citation

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.

Results Reference

derived

PubMed Identifier

32818460

Citation

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.

Results Reference

derived

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

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