CAIman 5 Articulating Maryland in coloRECTAL Cancer Surgery (CAIRECTAL)

July 14, 2021 updated by: Aesculap AG

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
61

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Germany
      • Essen, Germany, 45131
        • Alfried Krupp Krankenhaus Rüttenscheid

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

adult patients

Description

Inclusion Criteria:

  • Patient´s written informed consent
  • Planned laparoscopic colorectal cancer surgery using Caiman 5 articulating Maryland (according to the IfU)
  • Age ≥18 years

Exclusion Criteria:

  • 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)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Total operative time
Time Frame: intraoperatively
Time between first incision and closure of the surgical incision
intraoperatively

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Complications
Time Frame: up to 4 months postoperative
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
up to 4 months postoperative
Handling characteristics
Time Frame: intraoperative
Evaluation of performance and handling characteristics using a questionnaire containing 5-level Likert scales (excellent, very good, good, fair, poor)
intraoperative
Estimated intraoperative blood loss
Time Frame: intraoperative
intraoperative blood loss in ml
intraoperative
Time needed for TME
Time Frame: Intraoperative
Time between end of left flexure mobilization and stapling
Intraoperative
Time needed for PME
Time Frame: Intraoperative
Time [in minutes] between end of left flexure mobilization and stapling
Intraoperative
Time needed for CME
Time Frame: Intraoperative
Time [in minutes] between end of ileocolic vessels clipping and start of right flexure mobilization
Intraoperative
Time needed for right / hepatic colic flexure mobilization
Time Frame: Intraoperative
Time [in minutes] between end CME and start of resection of the mesentery of the small intestine
Intraoperative
Time needed for left / splenic colic flexure mobilization
Time Frame: Intraoperative
Time [in minutes] between clipping of inferior mesenteric vessels and start of TME, PME or corresponding)
Intraoperative
Stay in intensive care unit postop
Time Frame: up to discharge (approximately 10 days postoperative)
Number of days postoperative until discharge from intensive care unit
up to discharge (approximately 10 days postoperative)
Stay in intermediate care unit stay postop
Time Frame: up to discharge (approximately 10 days postoperative)
Number of days postoperative until discharge from intermediate care unit stay
up to discharge (approximately 10 days postoperative)
First postoperative oral intake
Time Frame: up to discharge (approximately 10 days postoperative)
Number of days until patient's first postoperative oral intake
up to discharge (approximately 10 days postoperative)
First postoperative stool
Time Frame: up to discharge (approximately 10 days postoperative)
Number of days until patient's first postoperative stool after oral intake
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)
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.)
up to discharge (approximately 10 days postoperative)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Aesculap AG

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Niedergethmann, Prof. Dr. med., Alfried Krupp Krankenhaus, 45131 Essen

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
January 2, 2020

Primary Completion (ACTUAL)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
January 10, 2021

Study Completion (ACTUAL)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
April 28, 2021

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
November 19, 2019

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 21, 2019

First Posted (ACTUAL)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
November 25, 2019

Study Record Updates

Last Update Posted (ACTUAL)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
July 15, 2021

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 14, 2021

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
July 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • AAG-O-H-1627

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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