Clinical trial · Interventional
Mechanical Bowel Preparation and Oral Antibiotics Versus Mechanical Bowel Preparation Only Prior Rectal Surgery
Mechanical Bowel Preparation and Oral Antibiotics Versus Mechanical Bowel Preparation Only Prior Rectal Surgery - a Prospective, Randomized Controlled Trial
NCT04281667CI-TRIAL-00062236MOBILE2active not recruitingPhase 4ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (8)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Colorectal Cancer | Malignant Colorectal Neoplasm | CURATED_BROADER | 0.80 |
| Colorectal Carcinoma | Colorectal Carcinoma | ONTOLOGY_EXACT | 0.98 |
| Colorectal Neoplasms | Colorectal Neoplasm | ONTOLOGY_EXACT | 0.98 |
| Rectal Adenocarcinoma | Rectal Adenocarcinoma | ONTOLOGY_EXACT | 0.98 |
| Rectum Carcinoma | — | UNRESOLVED | — |
| Rectum Neoplasm | — | UNRESOLVED | — |
| Surgery--Complications | — | UNRESOLVED | — |
| Surgical Site Infection | — | UNRESOLVED | — |
Interventions
Interventions (3)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Mechanical Bowel Preparation | Drug | — | UNRESOLVED |
| Oral Antibiotics | Drug | — | UNRESOLVED |
| Placebo | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Mechanical Bowel Preparation and Oral Antibiotics
- description
- Mechanical Bowel Preparation and Oral Antibiotics
- interventionNames
- Drug: Oral Antibiotics
- Drug: Mechanical Bowel Preparation
- type
- ACTIVE_COMPARATOR
- label
- Mechanical Bowel Preparation Only
- description
- Mechanical Bowel Preparation Only
- interventionNames
- Drug: Placebo
- Drug: Mechanical Bowel Preparation
Primary outcomes (1)
- measure
- Comprehensive Complication Index
- timeFrame
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Patients scheduled for anterior rectal resection with primary anastomosis Exclusion Criteria: * Emergency operation * Bowel obstruction * Existing stoma * Other reason preventing mechanical bowel preparation * Allergy to neomycin or metronidazole * Age \< 18 years * Lack of co-operation Exclusion criteria after randomization: * Patient did not undergo surgery * Anterior resection was not performed * Colonic anastomosis was not performed
References
Publications (4)
- DERIVEDKoskenvuo 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. PMID 38506889
- DERIVEDWillis 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. PMID 36748942
- DERIVEDKoskenvuo 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. PMID 34244284
- DERIVEDKoskenvuo 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. PMID 32818460