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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT02579330
Other study ID # 2015-341
Secondary ID
Status Not yet recruiting
Phase N/A
First received October 14, 2015
Last updated October 15, 2015
Start date December 2015
Est. completion date June 2016

Study information

Verified date October 2015
Source Cantonal Hosptal, Baselland
Contact Daniel C Steinemann, MD
Phone 0041 61 436 27 04
Email daniel.steinemann@ksbl.ch
Is FDA regulated No
Health authority Switzerland: Ethikkommission
Study type Interventional

Clinical Trial 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).


Recruitment information / eligibility

Status Not yet recruiting
Enrollment 22
Est. completion date June 2016
Est. primary completion date May 2016
Accepts healthy volunteers No
Gender Both
Age group 18 Years and older
Eligibility 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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment


Intervention

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.

Locations

Country Name City State
Switzerland Kantonsspital Baselland, Department of Surgery, Bruderholz Bruderholz

Sponsors (1)

Lead Sponsor Collaborator
Daniel Steinemann, MD

Country where clinical trial is conducted

Switzerland, 

Outcome

Type Measure Description Time frame Safety issue
Primary Grade of macroscopic contamination according to adjusted Boston Bowel Preparation Score (0-3). during initial surgery No
Secondary 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 No
Secondary 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 Yes
Secondary 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) No
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