Trial on Use of Coloshield in Transanal and Anal Surgery

October 15, 2015 updated by: Daniel Steinemann, MD

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

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).

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

22

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Switzerland
      • Bruderholz, Switzerland, 4101
        • Kantonsspital Baselland, Department of Surgery, Bruderholz

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: SINGLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: Coloshield Group
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.
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.
SHAM_COMPARATOR: Control Group
In the control Group the grade of macroscopic contamination will be assessed after rectal washout with 500ml of saline solution.
Other: Control
In the control group no device is introduced but a rectal washout with 500ml of Saline solution in performed.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Grade of macroscopic contamination according to adjusted Boston Bowel Preparation Score (0-3).
Time Frame: during initial surgery
during initial surgery

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Stable position of Coloshield
Time Frame: 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.
during initial surgery
Injuries of the rectal mucosa
Time Frame: 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.
during initial surgery
Postoperative pain (VAS-score)
Time Frame: 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.
during hospitalisation (48h)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Daniel Steinemann, MD

Investigators

  • Principal Investigator: Daniel C Steinemann, MD, Cantonal Hospital Baselland, Switzerland

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

December 1, 2015

Primary Completion (ANTICIPATED)

May 1, 2016

Study Completion (ANTICIPATED)

June 1, 2016

Study Registration Dates

First Submitted

October 14, 2015

First Submitted That Met QC Criteria

October 15, 2015

First Posted (ESTIMATE)

October 19, 2015

Study Record Updates

Last Update Posted (ESTIMATE)

October 19, 2015

Last Update Submitted That Met QC Criteria

October 15, 2015

Last Verified

October 1, 2015

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2015-341

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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