Trial on Use of Coloshield in Transanal and Anal Surgery

Daniel Steinemann, MD

Status: Unknown

Conditions: Anal Fissure; Rectal Polyp; Fistula-in-ano; Hemorrhoids; Rectal Adenoma

Treatments: Device: Coloshield; Other: Control

Study type: Interventional

Funder types: Other

Identifiers

NCT02579330

2015-341

Details and patient eligibility

About

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).

Enrollment: 22 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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22 participants in 2 patient groups

Coloshield Group

Experimental group

Description:

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.

Treatment:

Device: Coloshield

Other: Control

Control Group

Sham Comparator group

Description:

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

Treatment:

Other: Control