Fistula-in-anoNCT02579330
Trial on Use of Coloshield in Transanal and Anal Surgery
A study testing Coloshield in people with Fistula-in-ano and Rectal Polyp, run by Daniel Steinemann, MD at 1 site in Switzerland.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Fistula-in-ano, Rectal Polyp, Rectal Adenoma
- What is being tested?
- Coloshield
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 22 participants
- Where
- 1 siteSwitzerland
- Study dates
- Dec 2015to Jun 2016
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients undergoing surgery for Fistula-in-ano, transanal resection of rectal Polyp or Adenoma, haemorrhoids or anal fissure.
Who cannot join
- 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
Show all 9Show fewer
- status post rectal resection or pelvic Radiation therapy
- inflammatory bowel disease with inclusion of the rectum
- need for mechanical bowel preparation
Trial locations and contacts
1 site in 1 country.
Switzerland1 site
Kantonsspital Baselland, Department of Surgery, Bruderholz
Bruderholz, 4101
About this study
Official title: Randomized Controlled Trial on Practicability of Coloshield in Transanal and Anal Surgery
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
- Being tested
- Coloshield, Control
- Medical subject headings
- Rectal Fistula, Hemorrhoids, Fissure in Ano
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
ControlOther
In the control group no device is introduced but a rectal washout with 500ml of Saline solution in performed.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Device: Coloshield; Other: 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. Receives: Other: Control |
What is being measured
The primary outcome is the main question the study is designed to answer.
Grade of macroscopic contamination according to adjusted Boston Bowel Preparation Score (0-3).
Measured: during initial surgery
Secondary outcomes (3)
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.
Measured: during initial surgery
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.
Measured: during initial surgery
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.
Measured: during hospitalisation (48h)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Oct 2015 (estimated)
- Study startDec 2015
- Primary completionMay 2016 (estimated)
- Study completionJun 2016 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Fistula-in-anoStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 22 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Daniel Steinemann, MD
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Daniel Steinemann, MD, Cantonal Hospital, Baselland
- Investigators
- Daniel C Steinemann, MD, Principal investigator, Cantonal Hospital Baselland, Switzerland
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02579330
- Sponsor's protocol ID
- 2015-341
- Status last verified
- Oct 2015
- First submitted
- 14 Oct 2015
- Last updated
- 19 Oct 2015
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 32968914
Study at a glance
From the registry record, last updated by the sponsor on 19 Oct 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized Controlled Trial on Practicability of Coloshield in Transanal and Anal Surgery
- ClinicalTrials.gov ID
- NCT02579330
- Acronym / sponsor ID
- 2015-341
- Conditions
- Fistula-in-ano, Rectal Polyp, Rectal Adenoma, Hemorrhoids, Anal Fissure
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 22 participants (estimated)
- Lead sponsor
- Daniel Steinemann, MDUniversity, hospital or other
- Study start
- Dec 2015
- Primary completion
- May 2016 (estimated)
- Study completion
- Jun 2016 (estimated)
- First posted
- 19 Oct 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Coloshield Group | Experimental | Device: Coloshield, Other: ControlIn 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. |
| Control Group | Sham comparator | Other: ControlIn the control Group the grade of macroscopic contamination will be assessed after rectal washout with 500ml of saline solution. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Patients undergoing surgery for Fistula-in-ano, transanal resection of rectal Polyp or Adenoma, haemorrhoids or anal fissure.
Key exclusion criteria (9 listed)
- Age <18 years
- inability to give informed consent
- pregnancy
- missing informed consent
- emergency Operation (<24hours of diagnosis and admission at emergency room)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ColoshieldColoshield 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. | Device | Coloshield Group |
| ControlIn the control group no device is introduced but a rectal washout with 500ml of Saline solution in performed. | Other | Coloshield Group, Control Group |
Primary outcome
Grade of macroscopic contamination according to adjusted Boston Bowel Preparation Score (0-3).
Time frame: during initial surgery
3 secondary outcomes
Stable position of Coloshield
Time frame: during initial surgery
Injuries of the rectal mucosa
Time frame: during initial surgery
Postoperative pain (VAS-score)
Time frame: during hospitalisation (48h)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Oct 2015.
- Derived from this study: PubMed 32968914Cordewener 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Daniel C Steinemann, MD principal investigator
Cantonal Hospital Baselland, Switzerland
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Coloshield in people with Fistula-in-ano and Rectal Polyp, run by Daniel Steinemann, MD at 1 site in Switzerland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 19 Oct 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Switzerland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Daniel C Steinemann, MD (0041 61 436 27 04, daniel.steinemann@ksbl.ch), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Grade of macroscopic contamination according to adjusted Boston Bowel Preparation Score (0-3). (time frame: during initial surgery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02579330, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Oct 2015.