Trial on Use of Coloshield in Transanal and Anal Surgery

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

22 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-12-31

Study Completion Date

2016-06-30

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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).

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Seton or Glue for Trans-sphincteric Anal Fistulas

NCT00929630

Anal Fistulas

TERMINATED PHASE3

Does the Stapled Transanal Rectal Resection (STARR Procedure) Has an Effect on Anal Compliance ?

NCT02052063

Rectocele Intussusception Surgery +1 more

UNKNOWN NA

SuperSeton Pilot Studie

NCT03654482

Perianal Fistula Perianal Crohn Disease

COMPLETED NA

Success Rate, Continence, and Quality of Life With a Bioprosthetic Plug for Treating Complex Anal Fistula

NCT01612195

Complex Anal Fistula

COMPLETED PHASE2

Non-Operative Management in Patients With Iatrogenic Colorectal Perforations

NCT07299864

Iatrogenic Colorectal Perforations

COMPLETED

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

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

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

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.

Group Type EXPERIMENTAL

Coloshield

Intervention Type DEVICE

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.

Control

Intervention Type OTHER

In the control group no device is introduced but a rectal washout with 500ml of Saline solution in performed.

Control Group

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

Group Type SHAM_COMPARATOR

Control

Intervention Type OTHER

In the control group no device is introduced but a rectal washout with 500ml of Saline solution in performed.

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

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.

Intervention Type DEVICE

Control

In the control group no device is introduced but a rectal washout with 500ml of Saline solution in performed.

Intervention Type OTHER

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No