|
ISRCTN
|
ISRCTN70107172
|
|
ClinicalTrials.gov identifier
|
|
|
Public title
|
Impact of rectal washout on bacterial contamination caused by transrectal access for natural-orifice transluminal endoscopic surgery (NOTES)
|
|
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
|
|
Serial number at source
|
N/A
|
|
Study hypothesis
|
The null-hypothesis states that the probability of bacterial contamination caused by transrectal access measured by a swab of the circular stapler’s 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.
|
|
Lay summary
|
Not provided at time of registration
|
|
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
|
|
Countries of recruitment
|
Germany
|
|
Disease/condition/study domain
|
Patients undergoing sigmoid resection or left hemicolectomy
|
|
Participants - 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
|
|
Participants - 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
|
|
Anticipated start date
|
01/12/2011
|
|
Anticipated end date
|
01/12/2012
|
|
Status of trial
|
Ongoing |
|
Patient information material
|
Not available in web format, please use the contact details below to request a patient information sheet
|
|
Target number of participants
|
69
|
|
Interventions
|
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
|
|
Primary outcome measure(s)
|
Bacterial contamination at the circular stapler’s center rod following experimental intervention (rectal washout with 5% povidone iodine using an applicator) and control intervention
|
|
Secondary outcome measure(s)
|
1. Bacterial contamination at the circular stapler’s 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
|
|
Sources of funding
|
University of Heidelberg (Germany)
|
|
Trial website
|
|
|
Publications
|
|
|
Contact name
|
Dr
Beat
Mueller
|
|
Address
|
Klinik für Allgemein-, Viszeral- und Transplantationschirurgie
Universität Heidelberg
Im Neuenheimer Feld 110
|
|
City/town
|
Heidelberg
|
|
Zip/Postcode
|
69120
|
|
Country
|
Germany
|
|
Tel
|
+49 (0) 6221 56 8641
|
|
Email
|
beat.mueller@med.uni-heidelberg.de
|
|
Sponsor
|
University of Heidelberg (Germany)
|
|
Address
|
Klinik für Allgemein-, Viszeral- und Transplantationschirurgie
Universität Heidelberg
Im Neuenheimer Feld 110
|
|
City/town
|
Heidelberg
|
|
Zip/Postcode
|
69120
|
|
Country
|
Germany
|
|
Email
|
markus.buechler@med.uni-heidelberg.de
|
|
Sponsor website:
|
http://www.uni-heidelberg.de/index_e.html
|
|
Date applied
|
05/10/2011
|
|
Last edited
|
15/11/2011
|
|
Date ISRCTN assigned
|
15/11/2011
|
