Trial on Use of Coloshield in Transanal and Anal Surgery

Hemorrhoids Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT02579330
• Other study ID #: 2015-341
• 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

Related Conditions & MeSH terms

• Anal Fissure
• Fissure in Ano
• Fistula-in-ano
• Hemorrhoids
• Rectal Adenoma
• Rectal Polyp

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