Contact information
Type
Scientific
Primary contact
Dr Beat Mueller
ORCID ID
Contact details
Klinik für Allgemein-
Viszeral- und Transplantationschirurgie
Universität Heidelberg
Im Neuenheimer Feld 110
Heidelberg
69120
Germany
+49 (0) 6221 56 8641
beat.mueller@med.uni-heidelberg.de
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
N/A
Study information
Scientific title
Impact of rectal washout on bacterial contamination caused by transrectal access for natural-orifice transluminal endoscopic surgery (NOTES): a randomized controlled trial
Acronym
NOBACT II
Study hypothesis
The null-hypothesis states that the probability of bacterial contamination caused by transrectal access measured by a swab of the circular staplers center rod is the same for experimental intervention and control intervention. The alternative hypothesis states that the experimental interventions and the control intervention perform differently in terms of primary efficacy endpoint.
Ethics approval
Ethics Committee of the University of Heidelberg approved on 25/05/2011, (ref: S-396/2010)
Study design
Prospective randomized controlled patient-blinded surgical trial with three parallel study groups
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Hospitals
Trial type
Treatment
Patient information sheet
Not available in web format, please use the contact details below to request a patient information sheet
Condition
Patients undergoing sigmoid resection or left hemicolectomy
Intervention
Experimental intervention:
1. Rectal washout with 5% povidon iodine using an applicator
2. Rectal washout with sodium chloride (NaCl) using an applicator
Control intervention:
Rectal washout with NaCl using an irrigation syringe
Intervention type
Drug
Phase
Not Applicable
Drug names
5% povidon iodine
Primary outcome measures
Bacterial contamination at the circular staplers center rod following experimental intervention (rectal washout with 5% povidone iodine using an applicator) and control intervention
Secondary outcome measures
1. Bacterial contamination at the circular staplers center rod following experimental intervention (rectal washout with NaCl using an applicator)
2. Bacterial count and routine cultures at rectal mucosa, center rod, small pelvis
3. Exploratory analyses
Overall trial start date
01/12/2011
Overall trial end date
01/12/2012
Reason abandoned
Eligibility
Participant inclusion criteria
1. Given indication for sigmoid resection or left hemicolectomy with primary anastomosis in the proximal rectum
2. Age > 18 years
3. Written informed consent
Participant type
Patient
Age group
Adult
Gender
Both
Target number of participants
69
Participant exclusion criteria
1. American Society of Anesthesiology patient (ASA) classification IV and V
2. Emergency operation (obstruction, bleeding, peritonitis)
3. Hand-sutured anastomosis
4. Ileus, colitis, pelvic infection
5. Reoperation
6. Anastomosis < 6cm from the anus
7. Ongoing antibiotic therapy
8. Iodine allergy
9. Hyperthyreosis
Recruitment start date
01/12/2011
Recruitment end date
01/12/2012
Locations
Countries of recruitment
Germany
Trial participating centre
Klinik für Allgemein-, Viszeral- und Transplantationschirurgie
Heidelberg
69120
Germany
Sponsor information
Organisation
University of Heidelberg (Germany)
Sponsor details
Klinik für Allgemein-
Viszeral- und Transplantationschirurgie
Universität Heidelberg
Im Neuenheimer Feld 110
Heidelberg
69120
Germany
markus.buechler@med.uni-heidelberg.de
Sponsor type
University/education
Website
Funders
Funder type
University/education
Funder name
University of Heidelberg (Germany)
Alternative name(s)
University of Heidelberg
Funding Body Type
private sector organisation
Funding Body Subtype
academic
Location
Germany
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Results - basic reporting
Publication summary