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Trial on Use of Coloshield in Transanal and Anal Surgery

This study is not yet open for participant recruitment. (see Contacts and Locations)
Verified October 2015 by Cantonal Hosptal, Baselland
Sponsor:
Information provided by (Responsible Party):
Daniel Steinemann, MD, Cantonal Hosptal, Baselland
ClinicalTrials.gov Identifier:
NCT02579330
First received: October 14, 2015
Last updated: October 15, 2015
Last verified: October 2015
  Purpose
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).

Condition Intervention
Fistula-in-ano
Rectal Polyp
Rectal Adenoma
Hemorrhoids
Anal Fissure
Device: Coloshield
Other: Control

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Randomized Controlled Trial on Practicability of Coloshield in Transanal and Anal Surgery

Further study details as provided by Cantonal Hosptal, Baselland:

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

Secondary Outcome Measures:
  • 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.

  • 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.

  • 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.


Estimated Enrollment: 22
Study Start Date: December 2015
Estimated Study Completion Date: June 2016
Estimated Primary Completion Date: May 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

  Eligibility

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02579330

Contacts
Contact: Daniel C Steinemann, MD 0041 61 436 27 04 daniel.steinemann@ksbl.ch

Locations
Switzerland
Kantonsspital Baselland, Department of Surgery, Bruderholz
Bruderholz, Switzerland, 4101
Sponsors and Collaborators
Daniel Steinemann, MD
Investigators
Principal Investigator: Daniel C Steinemann, MD Cantonal Hospital Baselland, Switzerland
  More Information

Responsible Party: Daniel Steinemann, MD, Sponsor-Investigator, Cantonal Hosptal, Baselland
ClinicalTrials.gov Identifier: NCT02579330     History of Changes
Other Study ID Numbers: 2015-341
Study First Received: October 14, 2015
Last Updated: October 15, 2015

Additional relevant MeSH terms:
Fistula
Adenoma
Hemorrhoids
Fissure in Ano
Pathological Conditions, Anatomical
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Rectal Diseases
Intestinal Diseases
Gastrointestinal Diseases
Digestive System Diseases
Vascular Diseases
Cardiovascular Diseases
Anus Diseases

ClinicalTrials.gov processed this record on April 28, 2017