Vejle Hospital, Department of Surgery
Vejle, DK7100, Denmark
Location status: Recruiting
Location contact
Hans B Rahr, MD DMSc
CONTACT
Helle Gangelhof, RN
CONTACT
NCT Number: NCT04190589
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.
Interested in participating?
Request Info18 year and older
All sexes
Interventional
Not applicable
Vejle, DK7100, Denmark
Location status: Recruiting
Hans B Rahr, MD DMSc
CONTACT
Helle Gangelhof, RN
CONTACT
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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
Time frame: 30 days
As judged by pathologist (mesocolic/intramesocolic/intramuscular)
Time frame: 30 days
Number of nodes in specimen, as determined by pathologist
Time frame: 30 days
Postoperative complications, graded by Clavien-Dindo
Time frame: 30 days
Reinterventions under anesthesia before discharge from hospital
Time frame: 30 days
Days from operation to discharge from hospital
Time frame: 30 days
Readmissions to hospital 1-30 days after initial discharge
Time frame: intraoperative
Minutes from first incision to final stitch
Time frame: 30 days
Percentage of conversions from robotic to open surgery
Contact information is provided by the study sponsor or research team.
Hans B Rahr, MD DMSc
CONTACT
Lars Bundgaard, MD
CONTACT
Vejle Hospital
Other
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
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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