NCT02579330

Trial on Use of Coloshield in Transanal and Anal Surgery

Randomized Controlled Trial on Practicability of Coloshield in Transanal and Anal Surgery

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 22 (estimated)
• Sponsor: Daniel Steinemann, MD · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

In various transanal and anal procedures it is desirable to clean the operating field from stool contamination. Thus mechanical bowel preparation is not well tolerated by patients. Enema does not provide sufficient effect. By the use of Coloshield a rectal washout might be performed and enable a clean operating field. In this randomized controlled trial the macroscopic contamination of the rectum with and without Coloshield is compared using the Boston Bowel Preparation Score (0-3).

Conditions

• Fistula-in-ano
• Rectal Polyp
• Rectal Adenoma
• Hemorrhoids
• Anal Fissure

Interventions

Type	Name	Description
DEVICE	Coloshield	Coloshield is designed to occlude the rectum during surgery thus enabling the possibility for rectal washout and maintaining a clear operating field. The rod-shaped Instrument contains two silicon balloons which are inflated by means of a catheter. Several holes at the section in between the two balloons are connected to another catheter, which enable negative pressure to be established. By insufflation of the two balloons and establishment of a negative pressure between the balloons by means of connection to a closed drainage bottle the colon is occluded for the duration of surgery.
OTHER	Control	In the control group no device is introduced but a rectal washout with 500ml of Saline solution in performed.

Timeline

• Start date: 2015-12-01
• Primary completion: 2016-05-01
• Completion: 2016-06-01
• First posted: 2015-10-19
• Last updated: 2015-10-19

Locations

1 site across 1 country: Switzerland