Diverticulum, ColonNCT01880918
A RETROspective Data Collection of comPRESSion Anastomosis Using the ColonRing
An observational study of Diverticulum, Colon and Colorectal Neoplasms, run by novoGI at 3 sites in United States.
Trial summary
The proposed study is a post marketing, observational, retrospective data collection intended to gather and record data on patients treated with the ColonRing device in routine clinical practice at 4-6 centers. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Diverticulum, Colon, Colorectal Neoplasms, Crohn Disease
- How many people
- 200 participants
- Where
- 3 sitesUnited States
- Study dates
- Oct 2012to Jul 2013
- Phase
- Observational
- 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
Study population: Adult patients who underwent a laparoscopic or open Low Anterior resection with the creation of an anastomosis using the ColonRing in routine clinical practice.
Who may be able to join
- Patient was > 18 years old at time of procedure
- Patient underwent a technically successful open or laparoscopic colorectal, Low Anterior Resection procedure with the creation of an anastomosis using the ColonRing™
- Patient treated in routine clinical practice
- Patient underwent his/her first follow-up visit within two months post-surgery
Who cannot join
- No exclusion criteria have been defined for this data collection.
Trial locations and contacts
3 sites in 1 country.
United States3 sites, 3 recruiting
- Recruiting
Florida Hospital, Center for Colon & Rectal Surgery
Atlamonte Springs, Florida, 32701
Dr. Matthew Albert, MD, 407-303-5191
Leslee Cunnion, 407-303-5191, Leslee.Cunnion@flhosp.org
- Recruiting
18308 Murdock Circle, Suite 108
Port Charlotte, Florida
Dr. Domingo E. Galliano Jr., MD, 941-625-3411, office@gallianosurgery.com
Kathleen Lueck
- Recruiting
CoxHealth Hospital, Colorectal Department
Springfield, Missouri, 65807
Dr. Jose Dominguez, MD, 417-875-3211
Kami Oster, 417- 875-3211, Kami.Oster@coxhealth.com
About this study
Official title: Multi Center, Observational, Retrospective Data Collection of Patients Treated With the ColonRing in Routine Clinical Practice. This Study to Continue RETROPRESS Study ID NCT01301417
The proposed study is a post marketing, observational, retrospective data collection intended to gather and record data on patients treated with the ColonRing device in routine clinical practice at 4-6 centers. The data will assist in future evaluating the performance of the ColonRing device in regards to the creation of a colorectal anastomosis in Low Anterior Resection procedures.
Hypothesis: The performance of the ColonRing, determined by the rate of complications, will be within the acceptable range reported in the literature for alternative treatment modalities.
- Conditions
- Diverticulum, Colon, Colorectal Neoplasms, Crohn Disease, Colitis, Ulcerative, Colostomy, Ileostomy - Stoma
- Keywords
- Compression Anastomosis
- Medical subject headings
- Diverticulum, Colon, Colorectal Neoplasms, Crohn Disease, Colitis, Ulcerative, Rectal Prolapse, Intestinal Polyposis, Lymphoma, Endometriosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| ColonRing | The ColonRing device is intended to be used for the creation of intestinal anastomoses in colorectal surgery in both open and laparoscopic surgeries. This indication is within the currently cleared indication of the ColonRing device, which has been cleared by the US FDA and carries the CE Mark for use throughout the alimentary trct for the creation of circular end-to-end, side-to-end or side-to-side anastomosis. |
What is being measured
The primary outcome is the main question the study is designed to answer.
The rate of anastomotic leakage.
Anastomotic leakage is defined as evidence of a defect in the intestinal wall integrity at the anastomotic site leading to a communication between the intra and extra luminal compartments.
Measured: 6 weeks after the procedure
Secondary outcomes (1)
Rate of other device related complications and measures during hospitalization and post procedure.
The Following complications will be examined:
Bleeding. Stricture (either clinical evidence of a stricture or the inability to pass a 12 mm sigmoidoscope through the anastomosis in a procedure that does not include a diversion). Septic complication (including wound infection, pelvic infection, peritonitis, abscess) Readmission, re-operation, death within two months of the procedure Extra colonic complications (including urinary infection, urinary retention, DVT, pneumonitis, pulmonary embolism, cardiac, injury to other organs - e.g. spleen, ureter)
The following post operative measures will be reported:
Hospitalization duration (two dates will be recorded: ready for discharge and discharge). The latter noting where the patient was discharged to - e.g. nursing home or home. First day to first postoperative flatus. First day to first postoperative bowel movements. First day of first postoperative toleration of liquids and solids (time to "keeping them down")
Measured: 6 weeks after the procedure.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Jun 2013 (estimated)
- Study startOct 2012
- Primary completionJun 2013 (estimated)
- Study completionJul 2013 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diverticulum, ColonStudies 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
- Observational
- Time perspective
- Retrospective
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- novoGI
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01880918
- Sponsor's protocol ID
- RETROPRESS, CLPR-43-11-01
- Status last verified
- Jun 2013
- First submitted
- 16 Jun 2013
- Last updated
- 19 Jun 2013
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Jun 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Multi Center, Observational, Retrospective Data Collection of Patients Treated With the ColonRing in Routine Clinical Practice. This Study to Continue RETROPRESS Study ID NCT01301417
- ClinicalTrials.gov ID
- NCT01880918
- Acronym / sponsor ID
- RETROPRESS, CLPR-43-11-01
- Conditions
- Diverticulum, Colon, Colorectal Neoplasms, Crohn Disease, Colitis, Ulcerative, Colostomy, Ileostomy - Stoma
- Keywords
- Compression Anastomosis
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- novoGIIndustry (pharma, biotech, devices)
- Study start
- Oct 2012
- Primary completion
- Jun 2013 (estimated)
- Study completion
- Jul 2013 (estimated)
- First posted
- 19 Jun 2013 (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.
The proposed study is a post marketing, observational, retrospective data collection intended to gather and record data on patients treated with the ColonRing device in routine clinical practice at 4-6 centers. The data will assist in future evaluating the performance of the ColonRing device in regards to the creation of a colorectal anastomosis in Low Anterior Resection procedures.
Hypothesis: The performance of the ColonRing, determined by the rate of complications, will be within the acceptable range reported in the literature for alternative treatment modalities.
Study design
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| ColonRing | – | –The ColonRing device is intended to be used for the creation of intestinal anastomoses in colorectal surgery in both open and laparoscopic surgeries. This indication is within the currently cleared indication of the ColonRing device, which has been cleared by the US FDA and carries the CE Mark for use throughout the alimentary trct for the creation of circular end-to-end, side-to-end or side-to-side anastomosis. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Adult patients who underwent a laparoscopic or open Low Anterior resection with the creation of an anastomosis using the ColonRing in routine clinical practice.
Key inclusion criteria (4 listed)
- Patient was > 18 years old at time of procedure
- Patient underwent a technically successful open or laparoscopic colorectal, Low Anterior Resection procedure with the creation of an anastomosis using the ColonRing™
- Patient treated in routine clinical practice
- Patient underwent his/her first follow-up visit within two months post-surgery
Key exclusion criteria (1 listed)
- No exclusion criteria have been defined for this data collection.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
The rate of anastomotic leakage.
Time frame: 6 weeks after the procedure
Anastomotic leakage is defined as evidence of a defect in the intestinal wall integrity at the anastomotic site leading to a communication between the intra and extra luminal compartments.
1 secondary outcome
Rate of other device related complications and measures during hospitalization and post procedure.
Time frame: 6 weeks after the procedure.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Jun 2013.
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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.
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Diverticulum, Colon and Colorectal Neoplasms, run by novoGI at 3 sites in United States.
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 4 inclusion and 1 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 Jun 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in United States. 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. 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?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The rate of anastomotic leakage. (time frame: 6 weeks after the procedure). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 Jun 2013.