Trial on Use of Coloshield in Transanal and Anal Surgery

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).

In the Intervention group the Coloshield Device (double balloon system) will be introduced at the beginning of surgery followed by a washout of the rectum with 500ml of saline solution. The grade of macroscopic contamination will be assessed.

In the control Group the grade of macroscopic contamination will be assessed after rectal washout with 500ml of saline solution.

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.

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.

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.

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.

Inclusion Criteria: Patients undergoing surgery for Fistula-in-ano, transanal resection of rectal Polyp or Adenoma, haemorrhoids or anal fissure. Exclusion Criteria: Age <18 years inability to give informed consent pregnancy missing informed consent emergency Operation (<24hours of diagnosis and admission at emergency room) rectal strictures or Stenosis status post rectal resection or pelvic Radiation therapy inflammatory bowel disease with inclusion of the rectum need for mechanical bowel preparation

Cordewener C, Zurcher M, Muller PC, Muller-Stich BP, Zerz A, Linke GR, Steinemann DC. Randomized clinical trial on the use of a colon-occlusion device to assist rectal washout. Surg Endosc. 2021 Sep;35(9):5078-5087. doi: 10.1007/s00464-020-07992-9. Epub 2020 Sep 23.