Colorectal CancerCAIRECTALNCT04175756
CAIman 5 Articulating Maryland in coloRECTAL Cancer Surgery
An observational study of Colorectal Cancer, run by Aesculap AG at 1 site in Germany.
Trial summary
This voluntary study is part of a Post-Market-Surveillance plan to proactively collect clinical data for the use of Caiman 5 articulating Maryland in colorectal surgery under daily clinical routine. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Colorectal Cancer
- What is being tested?
- Caiman 5 articulating Maryland
- Type of treatment
- Medical device
- How many people
- 61 participants
- Where
- 1 siteGermany
- Study dates
- 2 Jan 2020to 28 Apr 2021
- 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 may be able to join
- Patient´s written informed consent
- Planned laparoscopic colorectal cancer surgery using Caiman 5 articulating Maryland (according to the IfU)
- Age ≥18 years
Who cannot join
- Emergency surgery
- Pregnancy
- Participation in another surgical study, which might influence the intraoperative process
- Conversion to open surgery
- Conversion to another sealing / cutting instrument (instead of Caiman 5 articulating Maryland)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: CAIman 5 Articulating Maryland in coloRECTAL Cancer Surgery. An Observational, Prospective, Post-marketing Clinical Follow-up Study
This voluntary study is part of a Post-Market-Surveillance plan to proactively collect clinical data for the use of Caiman 5 articulating Maryland in colorectal surgery under daily clinical routine.
- Conditions
- Colorectal Cancer
- Being tested
- Caiman 5 articulating Maryland
- Keywords
- colorectal cancer, laparoscopic surgery, Seal & Cut, Total Mesorectal Excision (TME), Partial Mesorectal Excision (PME), Complete Mesocolic Excision (CME)
- Medical subject headings
- Colorectal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Caiman 5 articulating MarylandDevice
Laparoscopic colorectal surgery
What is being measured
The primary outcome is the main question the study is designed to answer.
Total operative time
Time between first incision and closure of the surgical incision
Measured: intraoperatively
Secondary outcomes (13)
Complications
Number of Complications: Wound infections, Urinary tract infections, Pulmonary infections, Other infections, Wound dehiscence, Anastomotic leak, Anastomotic bleeding, Other bleeding / hemorrhage, Intraabdominal abscess, Fistula, Peritonitis, Sepsis, Hernia, Stenosis Ileus, Ureter injury, Nerve injury, Cardiac complications, Other
Measured: up to 4 months postoperative
Handling characteristics
Evaluation of performance and handling characteristics using a questionnaire containing 5-level Likert scales (excellent, very good, good, fair, poor)
Measured: intraoperative
Estimated intraoperative blood loss
intraoperative blood loss in ml
Measured: intraoperative
Time needed for TME
Time between end of left flexure mobilization and stapling
Measured: Intraoperative
Time needed for PME
Time [in minutes] between end of left flexure mobilization and stapling
Measured: Intraoperative
Time needed for CME
Time [in minutes] between end of ileocolic vessels clipping and start of right flexure mobilization
Measured: Intraoperative
Time needed for right / hepatic colic flexure mobilization
Time [in minutes] between end CME and start of resection of the mesentery of the small intestine
Measured: Intraoperative
Time needed for left / splenic colic flexure mobilization
Time [in minutes] between clipping of inferior mesenteric vessels and start of TME, PME or corresponding)
Measured: Intraoperative
Stay in intensive care unit postop
Number of days postoperative until discharge from intensive care unit
Measured: up to discharge (approximately 10 days postoperative)
Stay in intermediate care unit stay postop
Number of days postoperative until discharge from intermediate care unit stay
Measured: up to discharge (approximately 10 days postoperative)
First postoperative oral intake
Number of days until patient's first postoperative oral intake
Measured: up to discharge (approximately 10 days postoperative)
First postoperative stool
Number of days until patient's first postoperative stool after oral intake
Measured: up to discharge (approximately 10 days postoperative)
Quality of excision: M.E.R.C.U.R.Y. criteria
quality of mesorectal excision according to criteria established in the "Magnetic Resonance Imaging and Rectal Cancer European Equivalence Study" (M.E.R.C.U.R.Y.)
Measured: up to discharge (approximately 10 days postoperative)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Nov 2019
- Study start2 Jan 2020
- Primary completion10 Jan 2021
- Study completion28 Apr 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Colorectal CancerStudies of the same condition, open and under way.
- More trials run by Aesculap AGThe sponsor's other registered studies.
- 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
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 61 participants (actual)
Sponsor and investigators
- Lead sponsor
- Aesculap AG
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Niedergethmann, Prof. Dr. med., Principal investigator, Alfried Krupp Krankenhaus, 45131 Essen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04175756
- Sponsor's protocol ID
- AAG-O-H-1627
- Acronym
- CAIRECTAL
- Status last verified
- Jul 2021
- First submitted
- 19 Nov 2019
- Last updated
- 15 Jul 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Jul 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- CAIman 5 Articulating Maryland in coloRECTAL Cancer Surgery. An Observational, Prospective, Post-marketing Clinical Follow-up Study
- ClinicalTrials.gov ID
- NCT04175756
- Acronym / sponsor ID
- CAIRECTAL / AAG-O-H-1627
- Conditions
- Colorectal Cancer
- Keywords
- colorectal cancer, laparoscopic surgery, Seal & Cut, Total Mesorectal Excision (TME), Partial Mesorectal Excision (PME), Complete Mesocolic Excision (CME)
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 61 participants (actual)
- Lead sponsor
- Aesculap AGIndustry (pharma, biotech, devices)
- Study start
- 2 Jan 2020 (actual)
- Primary completion
- 10 Jan 2021 (actual)
- Study completion
- 28 Apr 2021 (actual)
- First posted
- 25 Nov 2019 (actual)
- 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.
This voluntary study is part of a Post-Market-Surveillance plan to proactively collect clinical data for the use of Caiman 5 articulating Maryland in colorectal surgery under daily clinical routine.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- adult patients
Key inclusion criteria (3 listed)
- Patient´s written informed consent
- Planned laparoscopic colorectal cancer surgery using Caiman 5 articulating Maryland (according to the IfU)
- Age ≥18 years
Key exclusion criteria (5 listed)
- Emergency surgery
- Pregnancy
- Participation in another surgical study, which might influence the intraoperative process
- Conversion to open surgery
- Conversion to another sealing / cutting instrument (instead of Caiman 5 articulating Maryland)
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 |
|---|---|---|
| Caiman 5 articulating MarylandLaparoscopic colorectal surgery | Device | – |
Primary outcome
Total operative time
Time frame: intraoperatively
Time between first incision and closure of the surgical incision
13 secondary outcomes
Complications
Time frame: up to 4 months postoperative
Handling characteristics
Time frame: intraoperative
Estimated intraoperative blood loss
Time frame: intraoperative
Time needed for TME
Time frame: Intraoperative
Time needed for PME
Time frame: Intraoperative
Time needed for CME
Time frame: Intraoperative
Time needed for right / hepatic colic flexure mobilization
Time frame: Intraoperative
Time needed for left / splenic colic flexure mobilization
Time frame: Intraoperative
Stay in intensive care unit postop
Time frame: up to discharge (approximately 10 days postoperative)
Stay in intermediate care unit stay postop
Time frame: up to discharge (approximately 10 days postoperative)
First postoperative oral intake
Time frame: up to discharge (approximately 10 days postoperative)
First postoperative stool
Time frame: up to discharge (approximately 10 days postoperative)
Quality of excision: M.E.R.C.U.R.Y. criteria
Time frame: up to discharge (approximately 10 days postoperative)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Jul 2021.
Related trials for Colorectal Cancer
Not yet recruitingPhase 1
Hepatic Artery Infusion of Carfilzomib in Participants With Liver Metastatic Disease Previously Treated With Hepatic Artery Infusion Pump Therapy
Colorectal Neoplasms, Neoplasms
Active, not recruiting
Streamlined Geriatric and Oncological Evaluation Based On IC Technology
Breast Cancer, Comorbidities and Coexisting Conditions
RecruitingObservational study
Pre- and On-treatment Multi-omics Profiling of Locally Advanced Rectal Cancer
Rectal Neoplasms
Enrolling by invitationObservational study
Natural History Study of Early Life Exposures in Agriculture (ELEA)
Prostate Cancer, Leukemia
RecruitingPhase 2
Tislelizumab in People With Colorectal Cancer
Colorectal Cancer
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.
Niedergethmann, Prof. Dr. med. principal investigator
Alfried Krupp Krankenhaus, 45131 Essen
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Colorectal Cancer, run by Aesculap AG at 1 site in Germany.
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 3 inclusion and 5 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: finished, as of the sponsor's last update on 15 Jul 2021. 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 Germany. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Total operative time (time frame: intraoperatively). 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 15 Jul 2021.