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Trial on Use of Coloshield in Transanal and Anal Surgery

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ClinicalTrials.gov Identifier: NCT02579330
Recruitment Status : Unknown
Verified October 2015 by Daniel Steinemann, MD, Cantonal Hosptal, Baselland.
Recruitment status was:  Not yet recruiting
First Posted : October 19, 2015
Last Update Posted : October 19, 2015
Sponsor:
Information provided by (Responsible Party):
Daniel Steinemann, MD, Cantonal Hosptal, Baselland

Tracking Information
First Submitted Date  ICMJE October 14, 2015
First Posted Date  ICMJE October 19, 2015
Last Update Posted Date October 19, 2015
Study Start Date  ICMJE December 2015
Estimated Primary Completion Date May 2016   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: October 15, 2015)
Grade of macroscopic contamination according to adjusted Boston Bowel Preparation Score (0-3). [ Time Frame: during initial surgery ]
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE
 (submitted: October 15, 2015)
  • 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.
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Trial on Use of Coloshield in Transanal and Anal Surgery
Official Title  ICMJE Randomized Controlled Trial on Practicability of Coloshield in Transanal and Anal Surgery
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 Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE
  • Fistula-in-ano
  • Rectal Polyp
  • Rectal Adenoma
  • Hemorrhoids
  • Anal Fissure
Intervention  ICMJE
  • 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.
Study Arms  ICMJE
  • 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.
    Interventions:
    • Device: Coloshield
    • Other: Control
  • Sham Comparator: Control Group
    In the control Group the grade of macroscopic contamination will be assessed after rectal washout with 500ml of saline solution.
    Intervention: Other: Control
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Unknown status
Estimated Enrollment  ICMJE
 (submitted: October 15, 2015)
22
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE June 2016
Estimated Primary Completion Date May 2016   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Switzerland
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02579330
Other Study ID Numbers  ICMJE 2015-341
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Daniel Steinemann, MD, Cantonal Hosptal, Baselland
Study Sponsor  ICMJE Daniel Steinemann, MD
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Daniel C Steinemann, MD Cantonal Hospital Baselland, Switzerland
PRS Account Cantonal Hosptal, Baselland
Verification Date October 2015

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP