Impact of rectal washout on bacterial contamination caused by transrectal access for natural-orifice transluminal endoscopic surgery (NOTES)
| ISRCTN | ISRCTN70107172 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN70107172 |
| Secondary identifying numbers | N/A |
- Submission date
- 05/10/2011
- Registration date
- 15/11/2011
- Last edited
- 15/11/2011
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Surgery
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Record updated in last year
Plain English summary of protocol
Not provided at time of registration
Contact information
Dr Beat Mueller
Scientific
Scientific
Klinik für Allgemein-, Viszeral- und Transplantationschirurgie
Universität Heidelberg
Im Neuenheimer Feld 110
Heidelberg
69120
Germany
| Phone | +49 (0) 6221 56 8641 |
|---|---|
| beat.mueller@med.uni-heidelberg.de |
Study information
| Study design | Prospective randomized controlled patient-blinded surgical trial with three parallel study groups |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Hospital |
| Study type | Treatment |
| Participant information sheet | Not available in web format, please use the contact details below to request a patient information sheet |
| Scientific title | Impact of rectal washout on bacterial contamination caused by transrectal access for natural-orifice transluminal endoscopic surgery (NOTES): a randomized controlled trial |
| Study acronym | NOBACT II |
| Study objectives | 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(s) | Ethics Committee of the University of Heidelberg approved on 25/05/2011, (ref: S-396/2010) |
| Health condition(s) or problem(s) studied | 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 |
| Pharmaceutical study type(s) | |
| Phase | Not Applicable |
| Drug / device / biological / vaccine name(s) | 5% povidon iodine |
| Primary outcome measure | 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 study start date | 01/12/2011 |
| Completion date | 01/12/2012 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | Both |
| Target number of participants | 69 |
| Key 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 |
| Key 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 |
| Date of first enrolment | 01/12/2011 |
| Date of final enrolment | 01/12/2012 |
Locations
Countries of recruitment
- Germany
Study participating centre
Klinik für Allgemein-, Viszeral- und Transplantationschirurgie
Heidelberg
69120
Germany
69120
Germany
Sponsor information
University of Heidelberg (Germany)
University/education
University/education
Klinik für Allgemein-, Viszeral- und Transplantationschirurgie
Universität Heidelberg
Im Neuenheimer Feld 110
Heidelberg
69120
Germany
| markus.buechler@med.uni-heidelberg.de | |
| Website | http://www.uni-heidelberg.de/index_e.html |
"ROR" |
https://ror.org/038t36y30 |
Funders
Funder type
University/education
University of Heidelberg (Germany)
Government organisation / Universities (academic only)
Government organisation / Universities (academic only)
- Alternative name(s)
- University of Heidelberg, Ruprecht-Karls-Universität Heidelberg
- Location
- Germany
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | Not provided at time of registration |
| IPD sharing plan |
