Condition category
Surgery
Date applied
05/10/2011
Date assigned
15/11/2011
Last edited
15/11/2011
Prospective/Retrospective
Prospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

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 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.

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 stapler’s 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 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

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

http://www.uni-heidelberg.de/index_e.html

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

Publication citations

Additional files

Editorial Notes