Anal Fissure, Fistula-in-ano, Hemorrhoids, Rectal Adenoma, Rectal Polyp
Conditions
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).
Interventions
DEVICEColoshield
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.
OTHERControl
In the control group no device is introduced but a rectal washout with 500ml of Saline solution in performed.
Sponsors
Daniel Steinemann, MD
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Grade of macroscopic contamination according to adjusted Boston Bowel Preparation Score (0-3). | during initial surgery |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Stable position of Coloshield | 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 | 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) | 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. |
Countries
Switzerland
Contacts
Primary ContactDaniel C Steinemann, MD
Outcome results
None listed