Trial on Use of Coloshield in Transanal and Anal Surgery

Study Overview
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Brief Summary
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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).

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

Conditions
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Fistula-in-ano, Rectal Polyp, Rectal Adenoma, Hemorrhoids, Anal Fissure

Intervention / Treatment
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* Device: Coloshield
* Other: Control


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Coloshield Group<br>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. | Device: Coloshield<br>* 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.<br>Other: Control<br>* In the control group no device is introduced but a rectal washout with 500ml of Saline solution in performed.<br>|
| Sham Comparator: Control Group<br>In the control Group the grade of macroscopic contamination will be assessed after rectal washout with 500ml of saline solution. | Other: Control<br>* In the control group no device is introduced but a rectal washout with 500ml of Saline solution in performed.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Grade of macroscopic contamination according to adjusted Boston Bowel Preparation Score (0-3). |  | during initial surgery | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 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. | 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. | during hospitalisation (48h) |