CAIman 5 Articulating Maryland in coloRECTAL Cancer Surgery (CAIRECTAL)

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: Completed
• Conditions: Colorectal Cancer
• Intervention / Treatment: Device: Caiman 5 articulating Maryland

• Study Type: Observational
• Enrollment (Actual): 61

Contacts and Locations

Study Locations

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

Participation Criteria

Eligibility Criteria

• 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

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Total operative time	Time between first incision and closure of the surgical incision	intraoperatively

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	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)	intraoperative
Estimated intraoperative blood loss	intraoperative blood loss in ml	intraoperative
Time needed for TME	Time between end of left flexure mobilization and stapling	Intraoperative
Time needed for PME	Time [in minutes] between end of left flexure mobilization and stapling	Intraoperative
Time needed for CME	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 [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 [in minutes] between clipping of inferior mesenteric vessels and start of TME, PME or corresponding)	Intraoperative
Stay in intensive care unit postop	Number of days postoperative until discharge from intensive care unit	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	up to discharge (approximately 10 days postoperative)
First postoperative oral intake	Number of days until patient's first postoperative oral intake	up to discharge (approximately 10 days postoperative)
First postoperative stool	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	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

• Sponsor: Aesculap AG
• Investigators: Principal Investigator: Niedergethmann, Prof. Dr. med., Alfried Krupp Krankenhaus, 45131 Essen

Study record dates

Study Major Dates

• Study Start (ACTUAL): January 2, 2020
• Primary Completion (ACTUAL): January 10, 2021
• Study Completion (ACTUAL): April 28, 2021

Study Registration Dates

• First Submitted: November 19, 2019
• First Submitted That Met QC Criteria: November 21, 2019
• First Posted (ACTUAL): November 25, 2019

Study Record Updates

• Last Update Posted (ACTUAL): July 15, 2021
• Last Update Submitted That Met QC Criteria: July 14, 2021
• Last Verified: July 1, 2021

More Information

Terms related to this study

• Keywords: colorectal cancer; laparoscopic surgery; Seal & Cut; Total Mesorectal Excision (TME); Partial Mesorectal Excision (PME); Complete Mesocolic Excision (CME)
• Additional Relevant MeSH Terms: Digestive System Diseases; Neoplasms; Neoplasms by Site; Gastrointestinal Neoplasms; Digestive System Neoplasms; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Intestinal Neoplasms; Rectal Diseases; Colorectal Neoplasms
• Other Study ID 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