Trial on Use of Coloshield in Transanal and Anal Surgery

Not Applicable

• Conditions: Anal Fissure; Fistula-in-ano; Hemorrhoids; Rectal Polyp; Rectal Adenoma
• Interventions: Device: Coloshield; Other: Control

• Registration Number: NCT02579330
• Lead Sponsor: Daniel Steinemann, MD

Brief 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).

Detailed Description

Not available

Study Timeline

• Status Verified: 2015-10
• Study First Submitted: 2015-10-14
• Study First Submitted QC: 2015-10-15
• Last Update Submitted: 2015-10-15
• Study First Posted: 2015-10-19
• Last Update Posted: 2015-10-19
• Study Start: 2015-12
• Primary Completion: 2016-05
• Study Completion: 2016-06

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 22

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

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

Primary Outcome Measures

Name	Time	Method
Grade of macroscopic contamination according to adjusted Boston Bowel Preparation Score (0-3).	during initial surgery

Secondary Outcome Measures

Name	Time	Method
Stable position of Coloshield	during initial surgery	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.
Injuries of the rectal mucosa	during initial surgery	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.
Postoperative pain (VAS-score)	during hospitalisation (48h)	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.

Trial Locations

Locations (1)

Kantonsspital Baselland, Department of Surgery, Bruderholz; 🇨🇭 Bruderholz, Switzerland