Monocentric, two-level factorial, parallel-arm, pilot randomized clinical trial, conducted comparing patients undergoing laparoscopic right hemicolectomy with ICA for right colon cancer in a single unit of a teaching hospital: Minimally Invasive Surgery Unit, Department of Surgical Sciences, Policlinico Tor Vergata, Rome, Italy.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
36
19 Fr abdominal drainage placed intraoperatively in right colic gutter
Ceftriaxone 2 gr and Metronidazole 1.5 gr per day for 2 days postoperatively
the dissection starts over the landmark given by SMV. The SMV is freed anteriorly and on its right-hand side from all the lympho-adipose tissue. Once the SMV is fully exposed, the IC vessels are dissected and divided at the junction with the efferent vessels. The dissection moves upward along the same dissection line to identify the right colic vein and the GCTH. No medial to later dissection is carried out until the SMV is completely exposed before reaching the uncinate process of the pancreas. At this point the veins to the right colon are divided but gastroepiploic vein and artery are preserved unless the tumor is located at the hepatic flexure. The divided mesentery is lifted and tilted to the right, and the medial-to-later dissection starts following the embryological plane over Fredet's fascia. The mesocolon is divided on the right side of the middle colic artery and the right branches of the middle colic vessels are divided.
A medial-to-lateral surgical dissection and high tie of the ileocolic vessels (IC) is undertaken without dissecting the anterior surface of the superior mesenteric vein (SMV). The gastro-colic trunk of Henle (GCTH) is not isolated and the right colic vein (when present) and the right branches of the middle colic vessels are taken more peripherical, during the division of the transverse mesocolon. The right gastroepiploic vessels are not dissected, nor divided, unless in proximity of the tumor
University of Rome Tor Vergata
Rome, Italy
Tolerance to solid diet
time to light diet tolerance
Time frame: 30 days postoperatively
White blood cell
measured thousands/mL in I and III POD
Time frame: 30 days postoperatively
Procalcitonine
measured ng/ml in III and V POD
Time frame: 30 days postoperatively
Days of hospitalization
number of days of hospitalization
Time frame: 90 days postoperatively
Readmission rate
rate of hospital readmission
Time frame: 90 days postoperatively
Mortality rate
postoperative mortality
Time frame: 90 days postoperatively
Surgical site infection rate
postoperative wound infection
Time frame: 30 days postoperatively
Anastomotic leak rate
postoperative Ileocolic anastomotic leakage
Time frame: 30 days postoperatively
Tolerance to liquid diet
time to clear fluid tolerance
Time frame: 30 days postoperatively
Time to first flatus
Time to first flatus postoperatively
Time frame: 30 days postoperatively
Time to first evacuation
Time to first evacuation postoperatively
Time frame: 30 days postoperatively
need of abdomen CTscan rate
need of abdomen CTscan
Time frame: 30 days postoperatively
C-Reactive Proteine
measured mg/L in I and III POD
Time frame: 30 days postoperatively
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