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).
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
22
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.
In the control group no device is introduced but a rectal washout with 500ml of Saline solution in performed.
Kantonsspital Baselland, Department of Surgery, Bruderholz
Bruderholz, Switzerland
Grade of macroscopic contamination according to adjusted Boston Bowel Preparation Score (0-3).
Time frame: during initial surgery
Stable position of Coloshield
The position of the deployed Coloshield at beginning of surgery and after 30 minutes is measured by rigid rectoscopy in cm from anal verge. Any slippage of the device during surgery is documented.
Time frame: during initial surgery
Injuries of the rectal mucosa
After removal of Coloshield by rigid rectoscopy any bleedings or tear injuries in the rectal mucosa (caused by Coloshield) are noted. It will be documented if there are bleedings or tear injuries or not, and if the exact number of bleedings and tear injuries.
Time frame: during initial surgery
Postoperative pain (VAS-score)
The pain level on a VAS score from 0 (no pain) to 10 (strongest) 6 hours, 24 hours and 48 hours after surgery are documented.
Time frame: during hospitalisation (48h)
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