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

• Sponsor: Helsinki University Central Hospital (Other)
• Overall Status: Recruiting
• CT.gov ID: NCT04281667
• Collaborator: (none)
• Enrollment: 604
• Locations: 3
• Arms: 2
• Anticipated Duration (Months): 83.4
• Patients Per Site: 201.3
• Patients Per Site Per Month: 2.4

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Rectal Adenocarcinoma; Rectum Neoplasm; Rectum Carcinoma; Colorectal Cancer; Colorectal Neoplasms; Colorectal Carcinoma; Surgical Site Infection; Surgery--Complications	Drug: Oral Antibiotics; Drug: Placebo; Drug: Mechanical Bowel Preparation	Phase 4

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 604 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
• Primary Purpose: Prevention
• Official Title: Mechanical Bowel Preparation and Oral Antibiotics Versus Mechanical Bowel Preparation Only Prior Rectal Surgery - a Prospective, Randomized Controlled Trial
• Actual Study Start Date: Mar 18, 2020
• Anticipated Primary Completion Date: Mar 1, 2022
• Anticipated Study Completion Date: Mar 1, 2027

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Mechanical Bowel Preparation and Oral Antibiotics 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 Mechanical Bowel Preparation Only	Drug: Placebo; Oral placebos (placebo 1 and placebo 2 at 3pm and 11pm the day before surgery); Drug: Mechanical Bowel Preparation; Mechanical Bowel Preparation using 2L polyethylene glycol (Moviprep)

Outcome Measures

Primary Outcome Measures

1. Comprehensive Complication Index [Within 30 days from surgery]

   Comprehensive Complication Index score

Secondary Outcome Measures

1. Surgical Site Infection [Within 30 days from surgery]

   Surgical site infection as defined by CDC

2. Anastomotic dehiscence [Within 30 days from surgery]

   Anastomotic dehiscence

3. Lenght of hospital stay [Within hospital stay, estimated on average 7 days]

   Lenght of hospital stay

4. Mortality [Within 90 days from surgery]

   Mortality

5. Adjuvant therapy [Within 6 months from surgery]

   Patients receiving adjuvant therapy divided by patients needing adjuvant therapy

Other Outcome Measures

1. 5-year overall survival [5 years from surgery]

   5-year overall survival

2. 5-year disease specific survival [5 years from surgery]

   5-year disease specific survival

3. 5-year recurrence free survival [5 years from surgery]

   5-year recurrence free survival

4. Quality of life (SF-36) [At randomization and at one year from surgery]

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

5. Quality of life (QLQ-C30) [At randomization and at one year from surgery]

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

6. Quality of life (QLQ-CR29) [At randomization and at one year from surgery]

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

7. Quality of life (LARS) [At randomization and at one year from surgery]

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

8. Adverse effects of antibiotics [Within 30 days from surgery]

   Adverse effects of antibiotics

9. Bowel microbiota [Before, at, 6 months, and 1 year after surgery.]

   Bowel microbiota

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Helsinki University Hospital	Helsinki		Finland
2	Tampere University Hospital	Tampere		Finland
3	Turku University Hospital	Turku		Finland

Sponsors and Collaborators

• 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
• Study Director: Ville Sallinen, MD, PhD, Helsinki University Central Hospital

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Ville Sallinen, Adj. Prof., Helsinki University Central Hospital
• ClinicalTrials.gov Identifier: NCT04281667
• Other Study ID Numbers: 14112018
• First Posted: Feb 24, 2020
• Last Update Posted: Jun 3, 2021
• Last Verified: May 1, 2021

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Surgical Wound Infection; Carcinoma; Neoplasms; Colorectal Neoplasms; Rectal Neoplasms; Anti-Bacterial Agents

Study Results

No Results Posted as of Jun 3, 2021