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Impact of rectal washout on bacterial contamination caused by transrectal access for natural-orifice transluminal endoscopic surgery (NOTES)

Impact of rectal washout on bacterial contamination caused by transrectal access for natural-orifice transluminal endoscopic surgery (NOTES): a randomized controlled trial

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ISRCTN
Registry ID
ISRCTN70107172
Enrollment
69
Registered
2011-11-15
Start date
2011-12-01
Completion date
Unknown
Last updated
2015-01-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Patients undergoing sigmoid resection or left hemicolectomy Surgery Hemicolectomy

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 NaC

Sponsors

University of Heidelberg (Germany)
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

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

Exclusion criteria

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

Design outcomes

Primary

MeasureTime frame
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

MeasureTime frame
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

Countries

Germany

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 4, 2026