NCT02579330

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).

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
22

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Dec 2015

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 14, 2015

Completed
5 days until next milestone

First Posted

Study publicly available on registry

October 19, 2015

Completed
1 month until next milestone

Study Start

First participant enrolled

December 1, 2015

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2016

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2016

Completed
Last Updated

October 19, 2015

Status Verified

October 1, 2015

Enrollment Period

5 months

First QC Date

October 14, 2015

Last Update Submit

October 15, 2015

Conditions

Fistula-in-anoRectal PolypRectal AdenomaHemorrhoidsAnal Fissure

Outcome Measures

Primary Outcomes (1)

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

    during initial surgery

Secondary Outcomes (3)

  • Stable position of Coloshield

    during initial surgery

  • Injuries of the rectal mucosa

    during initial surgery

  • Postoperative pain (VAS-score)

    during hospitalisation (48h)

Study Arms (2)

Coloshield Group

EXPERIMENTAL

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.

Device: ColoshieldOther: Control

Control Group

SHAM COMPARATOR

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

Other: Control

Interventions

ColoshieldDEVICE

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.

Coloshield Group
ControlOTHER

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

Coloshield GroupControl Group

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patients undergoing surgery for Fistula-in-ano, transanal resection of rectal Polyp or Adenoma, haemorrhoids or anal fissure.

You may not qualify if:

  • 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
  • need for mechanical bowel preparation

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Kantonsspital Baselland, Department of Surgery, Bruderholz

Bruderholz, 4101, Switzerland

Location

Related Publications (1)

  • 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.

    PMID: 32968914DERIVED

MeSH Terms

Conditions

Rectal FistulaHemorrhoidsFissure in Ano

Condition Hierarchy (Ancestors)

Intestinal FistulaDigestive System FistulaDigestive System DiseasesIntestinal DiseasesGastrointestinal DiseasesRectal DiseasesFistulaPathological Conditions, AnatomicalPathological Conditions, Signs and SymptomsVascular DiseasesCardiovascular DiseasesAnus Diseases

Study Officials

  • Daniel C Steinemann, MD

    Cantonal Hospital Baselland, Switzerland

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Daniel C Steinemann, MD

CONTACT

0041 61 436 27 04daniel.steinemann@ksbl.ch

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Sponsor-Investigator

Study Record Dates

First Submitted

October 14, 2015

First Posted

October 19, 2015

Study Start

December 1, 2015

Primary Completion

May 1, 2016

Study Completion

June 1, 2016

Last Updated

October 19, 2015

Record last verified: 2015-10

Locations

CH(1)