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Completed

NCT Number: NCT04175756

CAIman 5 Articulating Maryland in coloRECTAL Cancer Surgery

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.

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Key information

Conditions

Colorectal Cancer Colonic Diseases Colorectal Neoplasms Digestive System Diseases Digestive System Neoplasms Gastrointestinal Diseases Gastrointestinal Neoplasms Intestinal Diseases Intestinal Neoplasms Neoplasms Neoplasms by Site Rectal Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Alfried Krupp Krankenhaus Rüttenscheid

Essen, 45131, Germany

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Caiman 5 articulating Maryland

Device

Laparoscopic colorectal surgery

Primary outcomes

  1. Total operative time

    Time frame: intraoperatively

    Time between first incision and closure of the surgical incision

Secondary outcomes

  1. 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

  2. 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)

  3. Estimated intraoperative blood loss

    Time frame: intraoperative

    intraoperative blood loss in ml

  4. Time needed for TME

    Time frame: Intraoperative

    Time between end of left flexure mobilization and stapling

  5. Time needed for PME

    Time frame: Intraoperative

    Time [in minutes] between end of left flexure mobilization and stapling

  6. Time needed for CME

    Time frame: Intraoperative

    Time [in minutes] between end of ileocolic vessels clipping and start of right flexure mobilization

  7. 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

  8. 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)

  9. 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

  10. 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

  11. First postoperative oral intake

    Time frame: up to discharge (approximately 10 days postoperative)

    Number of days until patient's first postoperative oral intake

  12. First postoperative stool

    Time frame: up to discharge (approximately 10 days postoperative)

    Number of days until patient's first postoperative stool after oral intake

  13. 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.)

Sponsors and collaborators

Lead sponsor

Aesculap AG

Industry

Registry information

Official study title

CAIman 5 Articulating Maryland in coloRECTAL Cancer Surgery. An Observational, Prospective, Post-marketing Clinical Follow-up Study

Acronym: CAIRECTAL

Important dates

Study start
2020
Primary completion
2021
Study completion
2021
First posted
Nov 25, 2019
Registry last updated
Jul 15, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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