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Trial on Use of Coloshield in Transanal and Anal Surgery

Primary Purpose

Fistula-in-ano, Rectal Polyp, Rectal Adenoma

Status
Unknown status
Phase
Not Applicable
Locations
Switzerland
Study Type
Interventional
Intervention
Coloshield
Control
Sponsored by
Daniel Steinemann, MD
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Fistula-in-ano

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

  • Kantonsspital Baselland, Department of Surgery, Bruderholz

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Sham Comparator

Arm Label

Coloshield Group

Control Group

Arm 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.

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

Outcomes

Primary Outcome Measures

Grade of macroscopic contamination according to adjusted Boston Bowel Preparation Score (0-3).

Secondary Outcome Measures

Stable position of Coloshield
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
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)
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.

Full Information

First Posted
October 14, 2015
Last Updated
October 15, 2015
Sponsor
Daniel Steinemann, MD
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1. Study Identification

Unique Protocol Identification Number
NCT02579330
Brief Title
Trial on Use of Coloshield in Transanal and Anal Surgery
Official Title
Randomized Controlled Trial on Practicability of Coloshield in Transanal and Anal Surgery
Study Type
Interventional

2. Study Status

Record Verification Date
October 2015
Overall Recruitment Status
Unknown status
Study Start Date
December 2015 (undefined)
Primary Completion Date
May 2016 (Anticipated)
Study Completion Date
June 2016 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Daniel Steinemann, MD

4. Oversight

Data Monitoring Committee
No

5. Study Description

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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Fistula-in-ano, Rectal Polyp, Rectal Adenoma, Hemorrhoids, Anal Fissure

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
22 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Coloshield Group
Arm Type
Experimental
Arm 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.
Arm Title
Control Group
Arm Type
Sham Comparator
Arm Description
In the control Group the grade of macroscopic contamination will be assessed after rectal washout with 500ml of saline solution.
Intervention Type
Device
Intervention Name(s)
Coloshield
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
Control
Intervention Description
In the control group no device is introduced but a rectal washout with 500ml of Saline solution in performed.
Primary Outcome Measure Information:
Title
Grade of macroscopic contamination according to adjusted Boston Bowel Preparation Score (0-3).
Time Frame
during initial surgery
Secondary Outcome Measure Information:
Title
Stable position of Coloshield
Description
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.
Time Frame
during initial surgery
Title
Injuries of the rectal mucosa
Description
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.
Time Frame
during initial surgery
Title
Postoperative pain (VAS-score)
Description
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.
Time Frame
during hospitalisation (48h)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Daniel C Steinemann, MD
Phone
0041 61 436 27 04
Email
daniel.steinemann@ksbl.ch
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Daniel C Steinemann, MD
Organizational Affiliation
Cantonal Hospital Baselland, Switzerland
Official's Role
Principal Investigator
Facility Information:
Facility Name
Kantonsspital Baselland, Department of Surgery, Bruderholz
City
Bruderholz
ZIP/Postal Code
4101
Country
Switzerland

12. IPD Sharing Statement

Citations:
PubMed Identifier
32968914
Citation
Cordewener C, Zurcher M, Muller PC, Muller-Stich BP, Zerz A, Linke GR, Steinemann DC. Randomized clinical trial on the use of a colon-occlusion device to assist rectal washout. Surg Endosc. 2021 Sep;35(9):5078-5087. doi: 10.1007/s00464-020-07992-9. Epub 2020 Sep 23.
Results Reference
derived

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Trial on Use of Coloshield in Transanal and Anal Surgery

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