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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Mechanical Bowel Preparation and Oral Antibiotics | Experimental | Mechanical Bowel Preparation and Oral Antibiotics |
|
| Mechanical Bowel Preparation Only | Active Comparator | Mechanical Bowel Preparation Only |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Oral Antibiotics | Drug | Oral antibiotics (neomycin 1g and metronidazole 1g at 3pm and 11pm the day before surgery) |
|
| Measure | Description | Time Frame |
|---|---|---|
| Comprehensive Complication Index | Comprehensive Complication Index score | Within 30 days from surgery |
| Measure | Description | Time Frame |
|---|---|---|
| Surgical Site Infection | Surgical site infection as defined by CDC | Within 30 days from surgery |
| Anastomotic dehiscence | Anastomotic dehiscence |
| Measure | Description | Time Frame |
|---|---|---|
| 5-year overall survival | 5-year overall survival | 5 years from surgery |
| 5-year disease specific survival | 5-year disease specific survival | 5 years from surgery |
Inclusion Criteria:
Exclusion Criteria:
Exclusion criteria after randomization:
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| Name | Affiliation | Role |
|---|---|---|
| Laura Koskenvuo, MD, PhD | Helsinki University Central Hospital | Principal Investigator |
| Anna Lepistö, MD, PhD | Helsinki University Central Hospital | Study Chair |
| Ville Sallinen, MD, PhD | Helsinki University Central Hospital | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Helsinki University Hospital | Helsinki | Finland | ||||
| Tampere University Hospital |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 38506889 | Derived | 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. | |
| 36748942 | Derived |
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Individual deidentified participant data will not be available for sharing. Study protocol will be available.
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| Placebo | Drug | Oral placebos (placebo 1 and placebo 2 at 3pm and 11pm the day before surgery) |
|
| Mechanical Bowel Preparation | Drug | Mechanical Bowel Preparation using 2L polyethylene glycol (Moviprep) |
|
| Within 30 days from surgery |
| Lenght of hospital stay | Lenght of hospital stay | Within hospital stay, estimated on average 7 days |
| Mortality | Mortality | Within 90 days from surgery |
| Adjuvant therapy | Patients receiving adjuvant therapy divided by patients needing adjuvant therapy | Within 6 months from surgery |
| 5-year recurrence free survival | 5-year recurrence free survival | 5 years from surgery |
| Quality of life (SF-36) | Difference in quality of life between baseline and 1 year measured using SF-36 | At randomization and at one year from surgery |
| Quality of life (QLQ-C30) | Difference in quality of life between baseline and 1 year measured using QLQ-C30 | At randomization and at one year from surgery |
| Quality of life (QLQ-CR29) | Difference in quality of life between baseline and 1 year measured using QLQ-CR29 | At randomization and at one year from surgery |
| Quality of life (LARS) | Difference in quality of life between baseline and 1 year measured using LARS | At randomization and at one year from surgery |
| Adverse effects of antibiotics | Adverse effects of antibiotics | Within 30 days from surgery |
| Bowel microbiota | Bowel microbiota | Before, at, 6 months, and 1 year after surgery. |
| Tampere |
| Finland |
| Turku University Hospital | Turku | Finland |
| 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. |
| 34244284 | Derived | 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. |
| 32818460 | Derived | 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. |
| ID | Term |
|---|---|
| D012004 | Rectal Neoplasms |
| D015179 | Colorectal Neoplasms |
| D013530 | Surgical Wound Infection |
| ID | Term |
|---|---|
| D007414 | Intestinal Neoplasms |
| D005770 | Gastrointestinal Neoplasms |
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D004066 | Digestive System Diseases |
| D005767 | Gastrointestinal Diseases |
| D007410 | Intestinal Diseases |
| D012002 | Rectal Diseases |
| D003108 | Colonic Diseases |
| D014946 | Wound Infection |
| D007239 | Infections |
| D011183 | Postoperative Complications |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| D000900 | Anti-Bacterial Agents |
| ID | Term |
|---|---|
| D000890 | Anti-Infective Agents |
| D045506 | Therapeutic Uses |
| D020228 | Pharmacologic Actions |
| D020164 | Chemical Actions and Uses |
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