Prospective Study of Extended Robotic Right Hemicolectomy With Complete Mesocolic Excision for Cancer
ConditionColorectal Cancer
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorVejle Hospital
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
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)
Trial design
Design model
Single group
Treatments tested in this trial
Robot-assisted laparoscopic extended right colectomy
DeviceAn 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
Treatment groups
40 Participants
are divided into 1 treatment groupGroup A: Robotic CMEExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Plane of dissection
As judged by pathologist (mesocolic/intramesocolic/intramuscular)
Time frame
30 days2
Lymph node count
Number of nodes in specimen, as determined by pathologist
Time frame
30 daysSecondary outcomes
1
Complications
Postoperative complications, graded by Clavien-Dindo
Time frame
30 days2
Reinterventions
Reinterventions under anesthesia before discharge from hospital
Time frame
30 days3
Length of stay
Days from operation to discharge from hospital
Time frame
30 days4
Readmissions
Readmissions to hospital 1-30 days after initial discharge
Time frame
30 daysOther outcomes
1
Operation time
Minutes from first incision to final stitch
Time frame
intraoperative2
Conversion rate
Percentage of conversions from robotic to open surgery
Time frame
30 daysSponsors and contacts
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Source ClinicalTrials.gov