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Trial on Use of Coloshield in Transanal and Anal Surgery

NCT02579330 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 22

Last updated 2015-10-19

No results posted yet for this study

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).

Conditions

  • Fistula-in-ano
  • Rectal Polyp
  • Rectal Adenoma
  • Hemorrhoids
  • Anal Fissure

Interventions

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.

Sponsors & Collaborators

  • Daniel Steinemann, MD

    lead OTHER

Principal Investigators

  • Daniel C Steinemann, MD · Cantonal Hospital Baselland, Switzerland

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2015-12-31
Primary Completion
2016-05-31
Completion
2016-06-30

Countries

  • Switzerland

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02579330 on ClinicalTrials.gov