Mechanical Bowel Preparation and Oral Antibiotics Versus Mechanical Bowel Preparation Only Prior Rectal Surgery
NCT ID: NCT04281667
Last Updated: 2022-11-17
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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ACTIVE_NOT_RECRUITING
PHASE4
604 participants
INTERVENTIONAL
2020-03-18
2027-10-10
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
QUADRUPLE
Study Groups
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Mechanical Bowel Preparation and Oral Antibiotics
Mechanical Bowel Preparation and Oral Antibiotics
Oral Antibiotics
Oral antibiotics (neomycin 1g and metronidazole 1g at 3pm and 11pm the day before surgery)
Mechanical Bowel Preparation
Mechanical Bowel Preparation using 2L polyethylene glycol (Moviprep)
Mechanical Bowel Preparation Only
Mechanical Bowel Preparation Only
Placebo
Oral placebos (placebo 1 and placebo 2 at 3pm and 11pm the day before surgery)
Mechanical Bowel Preparation
Mechanical Bowel Preparation using 2L polyethylene glycol (Moviprep)
Interventions
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Oral Antibiotics
Oral antibiotics (neomycin 1g and metronidazole 1g at 3pm and 11pm the day before surgery)
Placebo
Oral placebos (placebo 1 and placebo 2 at 3pm and 11pm the day before surgery)
Mechanical Bowel Preparation
Mechanical Bowel Preparation using 2L polyethylene glycol (Moviprep)
Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
* 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
18 Years
ALL
No
Sponsors
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Helsinki University Central Hospital
OTHER
Responsible Party
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Ville Sallinen
Adj. Prof.
Principal Investigators
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Laura Koskenvuo, MD, PhD
Role: PRINCIPAL_INVESTIGATOR
Helsinki University Central Hospital
Anna Lepistö, MD, PhD
Role: STUDY_CHAIR
Helsinki University Central Hospital
Ville Sallinen, MD, PhD
Role: STUDY_DIRECTOR
Helsinki University Central Hospital
Locations
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Helsinki University Hospital
Helsinki, , Finland
Tampere University Hospital
Tampere, , Finland
Turku University Hospital
Turku, , Finland
Countries
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References
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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.
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.
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.
Other Identifiers
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14112018
Identifier Type: -
Identifier Source: org_study_id
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