Rectal AdenocarcinomaPhase 4MOBILE2NCT04281667
Mechanical Bowel Preparation and Oral Antibiotics Versus Mechanical Bowel Preparation Only Prior Rectal Surgery
A Phase 4 study testing Oral Antibiotics and Mechanical Bowel Preparation in people with Rectal Adenocarcinoma and Rectum Neoplasm, run by Helsinki University Central Hospital at 3 sites in Finland.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Rectal Adenocarcinoma, Rectum Neoplasm, Rectum Carcinoma
- What is being tested?
- Oral Antibiotics and Mechanical Bowel Preparation
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 604 participants
- Where
- 3 sitesFinland
- Study dates
- 18 Mar 2020to 10 Oct 2027
- Phase
- Phase 4
- Are there results?
- Not yet: the study is under way
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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients scheduled for anterior rectal resection with primary anastomosis
Who cannot join
- Emergency operation
- Bowel obstruction
- Existing stoma
- Other reason preventing mechanical bowel preparation
- Allergy to neomycin or metronidazole
- Age < 18 years
Show all 10Show fewer
- Lack of co-operation
- Patient did not undergo surgery
- Anterior resection was not performed
- Colonic anastomosis was not performed
Trial locations and contacts
3 sites in 1 country.
Finland3 sites
Helsinki University Hospital
Helsinki
Tampere University Hospital
Tampere
Turku University Hospital
Turku
About this study
Official title: Mechanical Bowel Preparation and Oral Antibiotics Versus Mechanical Bowel Preparation Only Prior Rectal Surgery - a Prospective, Randomized Controlled Trial
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
- Being tested
- Oral Antibiotics, Placebo, Mechanical Bowel Preparation
- Medical subject headings
- Rectal Neoplasms, Colorectal Neoplasms, Surgical Wound Infection
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Oral AntibioticsDrug
Oral antibiotics (neomycin 1g and metronidazole 1g at 3pm and 11pm the day before surgery)
PlaceboDrug
Oral placebos (placebo 1 and placebo 2 at 3pm and 11pm the day before surgery)
Mechanical Bowel PreparationDrug
Mechanical Bowel Preparation using 2L polyethylene glycol (Moviprep)
| Study group | Role | What they receive |
|---|---|---|
| Mechanical Bowel Preparation and Oral Antibiotics | Experimental | Mechanical Bowel Preparation and Oral Antibiotics Receives: Drug: Oral Antibiotics; Drug: Mechanical Bowel Preparation |
| Mechanical Bowel Preparation Only | Active comparator | Mechanical Bowel Preparation Only Receives: Drug: Placebo; Drug: Mechanical Bowel Preparation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Comprehensive Complication Index
Comprehensive Complication Index score
Measured: Within 30 days from surgery
Secondary outcomes (5)
Surgical Site Infection
Surgical site infection as defined by CDC
Measured: Within 30 days from surgery
Anastomotic dehiscence
Anastomotic dehiscence
Measured: Within 30 days from surgery
Lenght of hospital stay
Lenght of hospital stay
Measured: Within hospital stay, estimated on average 7 days
Mortality
Mortality
Measured: Within 90 days from surgery
Adjuvant therapy
Patients receiving adjuvant therapy divided by patients needing adjuvant therapy
Measured: Within 6 months from surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Feb 2020
- Study start18 Mar 2020
- Primary completion9 Nov 2022
- Study completion10 Oct 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Rectal AdenocarcinomaStudies 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
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 604 participants (estimated)
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
- Investigators
- Laura Koskenvuo, MD, PhD, Principal investigator, Helsinki University Central HospitalAnna Lepistö, MD, PhD, Study chair, Helsinki University Central HospitalVille Sallinen, MD, PhD, Study director, Helsinki University Central Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04281667
- Sponsor's protocol ID
- 14112018
- Acronym
- MOBILE2
- Status last verified
- Nov 2022
- First submitted
- 14 Feb 2020
- Last updated
- 17 Nov 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Individual deidentified participant data will not be available for sharing. Study protocol will be available.
Publications
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.
PubMed 38506889Willis 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.
PubMed 36748942Koskenvuo 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.
PubMed 34244284Koskenvuo 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.
PubMed 32818460
Study at a glance
From the registry record, last updated by the sponsor on 17 Nov 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Mechanical Bowel Preparation and Oral Antibiotics Versus Mechanical Bowel Preparation Only Prior Rectal Surgery - a Prospective, Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT04281667
- Acronym / sponsor ID
- MOBILE2 / 14112018
- Conditions
- Rectal Adenocarcinoma, Rectum Neoplasm, Rectum Carcinoma, Colorectal Cancer, Colorectal Neoplasms, Colorectal Carcinoma
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 604 participants (estimated)
- Lead sponsor
- Helsinki University Central HospitalUniversity, hospital or other
- Study start
- 18 Mar 2020 (actual)
- Primary completion
- 9 Nov 2022 (actual)
- Study completion
- 10 Oct 2027 (estimated)
- First posted
- 24 Feb 2020 (actual)
- 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.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Mechanical Bowel Preparation and Oral Antibiotics | Experimental | Drug: Oral Antibiotics, Drug: Mechanical Bowel PreparationMechanical Bowel Preparation and Oral Antibiotics |
| Mechanical Bowel Preparation Only | Active comparator | Drug: Placebo, Drug: Mechanical Bowel PreparationMechanical Bowel Preparation Only |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Patients scheduled for anterior rectal resection with primary anastomosis
Key exclusion criteria (10 listed)
- Emergency operation
- Bowel obstruction
- Existing stoma
- Other reason preventing mechanical bowel preparation
- Allergy to neomycin or 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 |
|---|---|---|
| Oral AntibioticsOral antibiotics (neomycin 1g and metronidazole 1g at 3pm and 11pm the day before surgery) | Drug | Mechanical Bowel Preparation and Oral Antibiotics |
| PlaceboOral placebos (placebo 1 and placebo 2 at 3pm and 11pm the day before surgery) | Drug | Mechanical Bowel Preparation Only |
| Mechanical Bowel PreparationMechanical Bowel Preparation using 2L polyethylene glycol (Moviprep) | Drug | Mechanical Bowel Preparation Only, Mechanical Bowel Preparation and Oral Antibiotics |
Primary outcome
Comprehensive Complication Index
Time frame: Within 30 days from surgery
Comprehensive Complication Index score
5 secondary outcomes
Surgical Site Infection
Time frame: Within 30 days from surgery
Anastomotic dehiscence
Time frame: Within 30 days from surgery
Lenght of hospital stay
Time frame: Within hospital stay, estimated on average 7 days
Mortality
Time frame: Within 90 days from surgery
Adjuvant therapy
Time frame: Within 6 months from surgery
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Nov 2022.
- Derived from this study: PubMed 38506889Koskenvuo 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.
- Derived from this study: PubMed 36748942Willis 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.
- Derived from this study: PubMed 34244284Koskenvuo 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.
- Derived from this study: PubMed 32818460Koskenvuo 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.
- Individual participant dataSharing planned: No. Individual deidentified participant data will not be available for sharing. Study protocol will be available.
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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.
Laura Koskenvuo, MD, PhD principal investigator
Helsinki University Central Hospital
Anna Lepistö, MD, PhD study chair
Helsinki University Central Hospital
Ville Sallinen, MD, PhD study director
Helsinki University Central Hospital
3 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 Oral Antibiotics and Mechanical Bowel Preparation in people with Rectal Adenocarcinoma and Rectum Neoplasm, run by Helsinki University Central Hospital at 3 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 10 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: under way, not looking for participants, as of the sponsor's last update on 17 Nov 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 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?
This study is still under way. Results are not available in the source record yet.
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?
Comprehensive Complication Index (time frame: Within 30 days from surgery). 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 NCT04281667, which also lists 4 linked publications.
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 17 Nov 2022.