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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).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Coloshield Group | Experimental | 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. |
|
| Control Group | Sham Comparator | In the control Group the grade of macroscopic contamination will be assessed after rectal washout with 500ml of saline solution. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Coloshield | Device | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Grade of macroscopic contamination according to adjusted Boston Bowel Preparation Score (0-3). | during initial surgery |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Daniel C Steinemann, MD | Contact | 0041 61 436 27 04 | daniel.steinemann@ksbl.ch |
| Name | Affiliation | Role |
|---|---|---|
| Daniel C Steinemann, MD | Cantonal Hospital Baselland, Switzerland | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Kantonsspital Baselland, Department of Surgery, Bruderholz | Bruderholz | 4101 | Switzerland |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 32968914 | Derived | 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. |
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| ID | Term |
|---|---|
| D012003 | Rectal Fistula |
| D006484 | Hemorrhoids |
| D005401 | Fissure in Ano |
| ID | Term |
|---|---|
| D007412 | Intestinal Fistula |
| D016154 | Digestive System Fistula |
| D004066 | Digestive System Diseases |
| D007410 | Intestinal Diseases |
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|
| Control | Other | In the control group no device is introduced but a rectal washout with 500ml of Saline solution in performed. |
|
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) |
| D005767 | Gastrointestinal Diseases |
| D012002 | Rectal Diseases |
| D005402 | Fistula |
| D020763 | Pathological Conditions, Anatomical |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D001004 | Anus Diseases |