Clinical trial NCT04281667: Mechanical Bowel Preparation and Oral Antibiotics Versus Mechanical Bowel Preparation Only Prior Rectal Surgery
Official title: Mechanical Bowel Preparation and Oral Antibiotics Versus Mechanical Bowel Preparation Only Prior Rectal Surgery - a Prospective, Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: PHASE4
Conditions: Rectal Adenocarcinoma
Rectum Neoplasm
Rectum Carcinoma
Colorectal Cancer
Colorectal Neoplasms
Colorectal Carcinoma
Surgical Site Infection
Surgery--Complications
Lead sponsor: Helsinki University Central Hospital
Sponsor class: OTHER
First posted: 2020-02-24
Enrollment: 604
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief 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.


Eligibility criteria: 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

Primary outcomes:
measure: Comprehensive Complication Index
timeFrame: Within 30 days from surgery
Secondary outcomes:
measure: Surgical Site Infection
timeFrame: Within 30 days from surgery
measure: Anastomotic dehiscence
timeFrame: Within 30 days from surgery
measure: Lenght of hospital stay
timeFrame: Within hospital stay, estimated on average 7 days
measure: Mortality
timeFrame: Within 90 days from surgery
measure: Adjuvant therapy
timeFrame: Within 6 months from surgery
Other outcomes:
measure: 5-year overall survival
timeFrame: 5 years from surgery
measure: 5-year disease specific survival
timeFrame: 5 years from surgery
measure: 5-year recurrence free survival
timeFrame: 5 years from surgery
measure: Quality of life (SF-36)
timeFrame: At randomization and at one year from surgery
measure: Quality of life (QLQ-C30)
timeFrame: At randomization and at one year from surgery
measure: Quality of life (QLQ-CR29)
timeFrame: At randomization and at one year from surgery
measure: Quality of life (LARS)
timeFrame: At randomization and at one year from surgery
measure: Adverse effects of antibiotics
timeFrame: Within 30 days from surgery
measure: Bowel microbiota
timeFrame: Before, at, 6 months, and 1 year after surgery.
Locations:
city: Helsinki
country: Finland
facility: Helsinki University Hospital
city: Tampere
country: Finland
facility: Tampere University Hospital
city: Turku
country: Finland
facility: Turku University Hospital
Study officials:
affiliation: Helsinki University Central Hospital
name: Laura Koskenvuo, MD, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Helsinki University Central Hospital
name: Anna Lepistö, MD, PhD
role: STUDY_CHAIR
affiliation: Helsinki University Central Hospital
name: Ville Sallinen, MD, PhD
role: STUDY_DIRECTOR
References:
citation: 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.
citation: 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.