Colorectal SurgeryPhase 4NCT02652637
MOBILE Trial. Mechanical and Oral Antibiotic Bowel Preparation Versus no Bowel preparatIon for eLEctive Colectomy - a Multicenter, Prospective, Randomized, Controlled Trial.
A Phase 4 study testing neomycin, metronidazole, polyethylene glycol (PEG) in people with Colorectal Surgery, run by Helsinki University Central Hospital at 4 sites in Finland.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 95 years
- Conditions the study is for
- Colorectal Surgery
- What is being tested?
- neomycin, metronidazole, polyethylene glycol (PEG)
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 417 participants
- Where
- 4 sitesFinland
- Study dates
- Mar 2016to Aug 2023
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 95 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients undergoing colon resection
Who cannot join
- 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)
Trial locations and contacts
4 sites in 1 country.
Finland4 sites
Helsinki University Central Hospital
Helsinki, 00029
Central Finland Central Hospital
Jyväskylä
Oulu University Hospital
Oulu
Seinäjoki Central Hospital
Seinäjoki
About this study
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.
- Conditions
- Colorectal Surgery
- Being tested
- neomycin, metronidazole, polyethylene glycol (PEG)
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
neomycin, metronidazole, polyethylene glycol (PEG)Drug
| Study group | Role | What they receive |
|---|---|---|
| Mechanical and oral antibiotic bowel preparation | Experimental | Mechanical bowel preparation using PEG, neomycin 2g p.o. (single-dose), and metronidazole 2g p.o. (single dose) are given the day before surgery. Receives: Drug: neomycin, metronidazole, polyethylene glycol (PEG) |
| No bowel preparation | No intervention | No mechanical bowel preparation or oral antibiotics. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Surgical site infection (CDC criteria)
Measured: 30 days from operation
Secondary outcomes (8)
Comprehensive Complication Index
Measured: 30 days from operation
Anastomotic dehiscence
Measured: 30 days from operation
Reoperations
Measured: 30 days from operation
Readmissions
Measured: 30 days from operation
Length of hospital stay
Measured: During hospital stay, anticipated 2-30 days
Mortality
Measured: 30- and 90-days from operation
Adverse effects of antibiotics (diarrhea, clostridium)
Measured: 30 days from operation
Patients receiving adjuvant therapy divided by patients needing adjuvant therapy
Measured: 6 months from operation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jan 2016 (estimated)
- Study startMar 2016
- Primary completionSep 2018
- Study completionAug 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Colorectal SurgeryStudies of the same condition, open and under way.
- More trials run by Helsinki University Central HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Care provider, Investigator, Outcomes assessor
- Enrolment
- 417 participants (actual)
Sponsor and investigators
- Lead sponsor
- Helsinki University Central Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ville Sallinen, Helsinki University Central Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02652637
- Sponsor's protocol ID
- HYKS-MOBILE
- Status last verified
- Aug 2020
- First submitted
- 8 Jan 2016
- Last updated
- 24 Aug 2020
- Results posted
- No
Publications
Koskenvuo L, Lehtonen T, Koskensalo S, Rasilainen S, Klintrup K, Ehrlich A, Pinta T, Scheinin T, Sallinen V. Mechanical and oral antibiotic bowel preparation versus no bowel preparation for elective colectomy (MOBILE): a multicentre, randomised, parallel, single-blinded trial. Lancet. 2019 Sep 7;394(10201):840-848. doi: 10.1016/S0140-6736(19)31269-3. Epub 2019 Aug 8.
PubMed 31402112
Study at a glance
From the registry record, last updated by the sponsor on 24 Aug 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- MOBILE Trial. Mechanical and Oral Antibiotic Bowel Preparation Versus no Bowel preparatIon for eLEctive Colectomy - a Multicenter, Prospective, Randomized, Controlled Trial.
- ClinicalTrials.gov ID
- NCT02652637
- Acronym / sponsor ID
- HYKS-MOBILE
- Conditions
- Colorectal Surgery
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 417 participants (actual)
- Lead sponsor
- Helsinki University Central HospitalUniversity, hospital or other
- Study start
- Mar 2016 (actual)
- Primary completion
- Sep 2018 (actual)
- Study completion
- Aug 2023 (estimated)
- First posted
- 12 Jan 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Mechanical and oral antibiotic bowel preparation | Experimental | Drug: neomycin, metronidazole, polyethylene glycol (PEG)Mechanical bowel preparation using PEG, neomycin 2g p.o. (single-dose), and metronidazole 2g p.o. (single dose) are given the day before surgery. |
| No bowel preparation | No intervention | –No mechanical bowel preparation or oral antibiotics. |
Who may qualify
- Ages
- 18 to 95 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Patients undergoing colon resection
Key exclusion criteria (5 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| neomycin, metronidazole, polyethylene glycol (PEG) | Drug | Mechanical and oral antibiotic bowel preparation |
Primary outcome
Surgical site infection (CDC criteria)
Time frame: 30 days from operation
8 secondary outcomes
Comprehensive Complication Index
Time frame: 30 days from operation
Anastomotic dehiscence
Time frame: 30 days from operation
Reoperations
Time frame: 30 days from operation
Readmissions
Time frame: 30 days from operation
Length of hospital stay
Time frame: During hospital stay, anticipated 2-30 days
Mortality
Time frame: 30- and 90-days from operation
Adverse effects of antibiotics (diarrhea, clostridium)
Time frame: 30 days from operation
Patients receiving adjuvant therapy divided by patients needing adjuvant therapy
Time frame: 6 months from operation
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Aug 2020.
- Derived from this study: PubMed 31402112Koskenvuo L, Lehtonen T, Koskensalo S, Rasilainen S, Klintrup K, Ehrlich A, Pinta T, Scheinin T, Sallinen V. Mechanical and oral antibiotic bowel preparation versus no bowel preparation for elective colectomy (MOBILE): a multicentre, randomised, parallel, single-blinded trial. Lancet. 2019 Sep 7;394(10201):840-848. doi: 10.1016/S0140-6736(19)31269-3. Epub 2019 Aug 8.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing neomycin, metronidazole, polyethylene glycol (PEG) in people with Colorectal Surgery, run by Helsinki University Central Hospital at 4 sites in Finland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 24 Aug 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in Finland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Surgical site infection (CDC criteria) (time frame: 30 days from operation). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02652637, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Aug 2020.