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

NCT04281667 | Active Not Recruiting Phase 4

• 1 other identifier: 14112018
• Study Type: interventional
• Target: 604
• Locations: 1 country
• Sites: 3

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.

Conditions

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

Outcome Measures

Primary Outcomes (1)

• Comprehensive Complication Index

  Comprehensive Complication Index score

  Within 30 days from surgery

Secondary Outcomes (5)

• Surgical Site Infection

  Within 30 days from surgery

• Anastomotic dehiscence

  Within 30 days from surgery

• Lenght of hospital stay

  Within hospital stay, estimated on average 7 days

• Mortality

  Within 90 days from surgery

• Adjuvant therapy

  Within 6 months from surgery

Other Outcomes (9)

• 5-year overall survival

  5 years from surgery

• 5-year disease specific survival

  5 years from surgery

• 5-year recurrence free survival

  5 years from surgery

Study Arms (2)

Mechanical Bowel Preparation and Oral Antibiotics

EXPERIMENTAL

Mechanical Bowel Preparation and Oral Antibiotics

Drug: Oral Antibiotics; Drug: Mechanical Bowel Preparation

Mechanical Bowel Preparation Only

ACTIVE COMPARATOR

Mechanical Bowel Preparation Only

Drug: Placebo; Drug: Mechanical Bowel Preparation

Interventions

Oral Antibiotics DRUG

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

Mechanical Bowel Preparation and Oral Antibiotics

Placebo DRUG

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

Mechanical Bowel Preparation Only

Mechanical Bowel Preparation DRUG

Mechanical Bowel Preparation using 2L polyethylene glycol (Moviprep)

Mechanical Bowel Preparation Only; Mechanical Bowel Preparation and Oral Antibiotics

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients scheduled for anterior rectal resection with primary anastomosis

You may not qualify if:

• Emergency operation
• Bowel obstruction
• Existing stoma
• Other reason preventing mechanical bowel preparation
• Allergy to neomycin or metronidazole
• Age \< 18 years
• Lack of co-operation
• Patient did not undergo surgery
• Anterior resection was not performed
• Colonic anastomosis was not performed

Sponsors & Collaborators

• Helsinki University Central Hospital: lead

Study Sites (3)

Helsinki University Hospital

Helsinki, Finland

Location

Tampere University Hospital

Tampere, Finland

Location

Turku University Hospital

Turku, Finland

Location

Related Publications (4)

• Koskenvuo L, Lunkka P, Varpe P, Hyoty M, Satokari R, Haapamaki C, Lepisto A, Sallinen V. Morbidity After Mechanical Bowel Preparation and Oral Antibiotics Prior to Rectal Resection: The MOBILE2 Randomized Clinical Trial. JAMA Surg. 2024 Jun 1;159(6):606-614. doi: 10.1001/jamasurg.2024.0184.

  PMID: 38506889 DERIVED

• Willis MA, Toews I, Soltau SL, Kalff JC, Meerpohl JJ, Vilz TO. Preoperative combined mechanical and oral antibiotic bowel preparation for preventing complications in elective colorectal surgery. Cochrane Database Syst Rev. 2023 Feb 7;2(2):CD014909. doi: 10.1002/14651858.CD014909.pub2.

  PMID: 36748942 DERIVED

• 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.

  PMID: 34244284 DERIVED

• 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.

  PMID: 32818460 DERIVED

MeSH Terms

Conditions

Rectal Neoplasms; Colorectal Neoplasms; Surgical Wound Infection

Interventions

Anti-Bacterial Agents

Condition Hierarchy (Ancestors)

Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Intestinal Diseases; Rectal Diseases; Colonic Diseases; Wound Infection; Infections; Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Anti-Infective Agents; Therapeutic Uses; Pharmacologic Actions; Chemical Actions and Uses

Study Officials

• Laura Koskenvuo, MD, PhD

  Helsinki University Central Hospital

  PRINCIPAL INVESTIGATOR

• Anna Lepistö, MD, PhD

  Helsinki University Central Hospital

  STUDY CHAIR

• Ville Sallinen, MD, PhD

  Helsinki University Central Hospital

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Adj. Prof.

Study Record Dates

• First Submitted: February 14, 2020
• First Posted: February 24, 2020
• Study Start: March 18, 2020
• Primary Completion: November 9, 2022
• Study Completion (Estimated): October 10, 2027
• Last Updated: November 17, 2022

Record last verified: 2022-11

Data Sharing

• IPD Sharing: Will not share

Locations

FI (3)