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NCT Number: NCT04190589

Prospective Study of Extended Robotic Right Hemicolectomy With Complete Mesocolic Excision for Cancer

A single-center prospective study to elucidate whether extended robot-assisted right colectomy (e-RARC) performs as well as extended open right colectomy (e-ORC) in terms of specimen quality, and in addition, whether less postoperative morbidity and shorter length of stay (LOS) can be attained. Patients with colonic cancer near the right flexure or the oral part of the transverse colon will be compared excluding the most technically demanding and frail patients in both groups. A total of 40 patients undergoing e-RARC in a prospective series will be included and compared with 44 consecutive patients previously treated with e-ORC.

Recruiting

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

About this study

Complete mesocolic excision with central vascular ligation (CME) is an improvement of surgical technique in the operation for colonic cancer suggested to increase long-term survival. The concept was originally developed for open surgery by W. Hohenberger in Erlangen with excellent survival rates. However, if the tumor is located in the transverse colon or near the right colonic flexure, the procedure is particularly technically demanding, and for that reason most surgeons still prefer to do it by open operation (laparotomy) instead of the minimally invasive approach (laparoscopy) presently recommended for colonic cancer surgery. The advent of robotic surgery has improved the dexterity of instruments used in laparoscopic surgery and pushed the limits of what is possible with a minimally invasive approach. Since minimally invasive surgery is associated with better outcomes in terms of postoperative morbidity, pain, length of stay etc., it would be highly desirable if CME surgery could be done by robot-assisted laparoscopic operation instead of the current open approach. The current single-center study is proposed to elucidate whether extended robot-assisted right colectomy (e-RARC) performs as well as extended open right colectomy (e-ORC) in terms of specimen quality, and in addition, whether less postoperative morbidity and shorter length of stay (LOS) can be attained. Patients with colonic cancer near the right flexure or the oral part of the transverse colon will be compared excluding the most technically demanding and frail patients in both groups. A total of 40 patients undergoing e-RARC in a prospective series will be included and compared with 44 consecutive patients previously treated with e-ORC.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Suspected or verified colonic cancer visualized by colonoscopy and on CT in the anal part of the ascending colon, in the right flexure or in the oral 2/3 of the transverse colon
  • Patient is 18 years or older, legally competent and able to comprehend information and give consent
  • Tumor is UICC stage I-III on preop CT
  • Operation is elective

Exclusion criteria

  • Previous major open intraabdominal surgery
  • Ileus or other acute abdominal condition
  • CT scan with suspicion of T4 tumor
  • RITA score > 3 (Preop risk and frailty score)
  • BMI > 35 kg/m2
  • Project surgeon not available

Treatment and study plan

Robot-assisted laparoscopic extended right colectomy

Device

An extended right hemicolectomy with total mesocolic excision and meticulous central dissection as described by Hohenberger will be performed with the DaVinci Xi robot by one of two dedicated surgeons

Other names: DaVinci Xi

Primary outcomes

  1. Plane of dissection

    Time frame: 30 days

    As judged by pathologist (mesocolic/intramesocolic/intramuscular)

  2. Lymph node count

    Time frame: 30 days

    Number of nodes in specimen, as determined by pathologist

Secondary outcomes

  1. Complications

    Time frame: 30 days

    Postoperative complications, graded by Clavien-Dindo

  2. Reinterventions

    Time frame: 30 days

    Reinterventions under anesthesia before discharge from hospital

  3. Length of stay

    Time frame: 30 days

    Days from operation to discharge from hospital

  4. Readmissions

    Time frame: 30 days

    Readmissions to hospital 1-30 days after initial discharge

Other outcomes

  1. Operation time

    Time frame: intraoperative

    Minutes from first incision to final stitch

  2. Conversion rate

    Time frame: 30 days

    Percentage of conversions from robotic to open surgery

Study contacts

Contact information is provided by the study sponsor or research team.

Hans B Rahr, MD DMSc

CONTACT

[email protected]

+4520574529

Lars Bundgaard, MD

CONTACT

[email protected]

+4579405618

Sponsors and collaborators

Lead sponsor

Vejle Hospital

Other

Registry information

Official study title

A Single Center Prospective Study Comparing Robot-assisted and Open Operation With Complete Mesocolic Excision (CME) in Extended Right Colectomy for Colon Cancer in the Right Flexure and Transverse Colon

Important dates

Study start
2020
Primary completion
2026
Study completion
2026
First posted
Dec 9, 2019
Registry last updated
Jan 7, 2026

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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