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Trial record 16 of 61 for:    Neomycin sulfate

MOBILE Trial. Mechanical and Oral Antibiotic Bowel Preparation Versus no Bowel preparatIon for eLEctive Colectomy - a Multicenter, Prospective, Randomized, Controlled Trial.

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ClinicalTrials.gov Identifier: NCT02652637
Recruitment Status : Active, not recruiting
First Posted : January 12, 2016
Last Update Posted : December 31, 2018
Sponsor:
Information provided by (Responsible Party):
Ville Sallinen, Helsinki University Central Hospital

Brief Summary:
Enchanced recovery after surgery (ERAS) protocols aim to provide safer and quicker recovery postoperatively. One of the elements in ERAS protocols is that bowel is not prepared before colorectal surgery. However, several recent retrospective register studies have suggested that mechanical bowel preparation combined to oral antibiotics before colectomy reduces complications compared to no preparation at all. This trial compares these two strategies to find out whether complications can indeed be reduced by mechanically preparing the bowel with oral antibiotics.

Condition or disease Intervention/treatment Phase
Colorectal Surgery Drug: neomycin, metronidazole, polyethylene glycol (PEG) Phase 4

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 417 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: MOBILE Trial. Mechanical and Oral Antibiotic Bowel Preparation Versus no Bowel preparatIon for eLEctive Colectomy - a Multicenter, Prospective, Randomized, Controlled Trial.
Actual Study Start Date : March 2016
Actual Primary Completion Date : September 2018
Estimated Study Completion Date : August 2023

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Antibiotics

Arm Intervention/treatment
Experimental: Mechanical and oral antibiotic bowel preparation
Mechanical bowel preparation using PEG, neomycin 2g p.o. (single-dose), and metronidazole 2g p.o. (single dose) are given the day before surgery.
Drug: neomycin, metronidazole, polyethylene glycol (PEG)
No Intervention: No bowel preparation
No mechanical bowel preparation or oral antibiotics.



Primary Outcome Measures :
  1. Surgical site infection (CDC criteria) [ Time Frame: 30 days from operation ]

Secondary Outcome Measures :
  1. Comprehensive Complication Index [ Time Frame: 30 days from operation ]
  2. Anastomotic dehiscence [ Time Frame: 30 days from operation ]
  3. Reoperations [ Time Frame: 30 days from operation ]
  4. Readmissions [ Time Frame: 30 days from operation ]
  5. Length of hospital stay [ Time Frame: During hospital stay, anticipated 2-30 days ]
  6. Mortality [ Time Frame: 30- and 90-days from operation ]
  7. Adverse effects of antibiotics (diarrhea, clostridium) [ Time Frame: 30 days from operation ]
  8. Patients receiving adjuvant therapy divided by patients needing adjuvant therapy [ Time Frame: 6 months from operation ]

Other Outcome Measures:
  1. 5-year overall survival [ Time Frame: 5 years from operation ]
  2. 5-year disease specific survival [ Time Frame: 5 years from operation ]
  3. 5-year recurrence free survival [ Time Frame: 5 years from operation ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 95 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Patients undergoing colon resection

Exclusion Criteria:

  • Emergency surgery needed
  • Bowel obstruction
  • Colonoscopy scheduled to be undertaken peroperatively
  • Other reason indicating mechanical preparation or contradicting it
  • Allergy to used drugs (PEG, neomycin, metronidazole)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02652637


Locations
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Finland
Helsinki University Central Hospital
Helsinki, Finland, 00029
Central Finland Central Hospital
Jyvaskyla, Finland
Oulu University Hospital
Oulu, Finland
Seinäjoki Central Hospital
Seinäjoki, Finland
Sponsors and Collaborators
Helsinki University Central Hospital

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Ville Sallinen, MD, PhD, Helsinki University Central Hospital
ClinicalTrials.gov Identifier: NCT02652637     History of Changes
Other Study ID Numbers: HYKS-MOBILE
First Posted: January 12, 2016    Key Record Dates
Last Update Posted: December 31, 2018
Last Verified: December 2018

Additional relevant MeSH terms:
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Neomycin
Anti-Bacterial Agents
Metronidazole
Antibiotics, Antitubercular
Anti-Infective Agents
Antitubercular Agents
Antiprotozoal Agents
Antiparasitic Agents
Protein Synthesis Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action