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

NCT04281667 · Status: ACTIVE_NOT_RECRUITING · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 604

Last updated 2022-11-17

No results posted yet for this study

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

Interventions

DRUG

Oral Antibiotics

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

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)

Sponsors & Collaborators

  • Helsinki University Central Hospital

    lead OTHER

Principal Investigators

  • Laura Koskenvuo, MD, PhD · Helsinki University Central Hospital

  • Anna Lepistö, MD, PhD · Helsinki University Central Hospital

  • Ville Sallinen, MD, PhD · Helsinki University Central Hospital

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-03-18
Primary Completion
2022-11-09
Completion
2027-10-10

Countries

  • Finland

Study Locations

More Related Trials

Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04281667 on ClinicalTrials.gov