Colon Cancer
Conditions
Keywords
intracorporeal anastomosis, right hemicoletomy, colon cancer
Brief summary
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.
Interventions
PROCEDUREabdominal drainage
19 Fr abdominal drainage placed intraoperatively in right colic gutter
Ceftriaxone 2 gr and Metronidazole 1.5 gr per day for 2 days postoperatively
PROCEDURELaparoscopic radical right colectomy with CME and D3 lymphadenectomy (RRC)
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.
PROCEDURELaparoscopic standard D2 right hemicolectomy (STANDARD)
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
Sponsors
University of Rome Tor Vergata
Study design
Allocation
RANDOMIZED
Intervention model
FACTORIAL
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
Patients were initially randomized for postoperative management into three arms to receive prolonged antibiotic prophylaxis (ABX group), abdominal drain placement (DRAIN group) or neither (NONE group) (I level randomization). The same patients were further randomized for surgical technique in two arms to receive RRC (RRC group) or standard hemicolectomy with D2 dissection (STANDARD group) (II level of randomization).
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Right colon cancer * Intracorporeal anastomosis * Laparoscopic surgery * Elective surgery * informed consent signed
Exclusion criteria
* below 18 years old * IBD * ASA IV * T4b * Metastatic disease * Preoperative steroids * Conversion to open surgery * Emergency surgery * concomitant major operation * preoperative infective status * benign disease
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Tolerance to solid diet | 30 days postoperatively | time to light diet tolerance |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Procalcitonine | 30 days postoperatively | measured ng/ml in III and V POD |
| Days of hospitalization | 90 days postoperatively | number of days of hospitalization |
| Readmission rate | 90 days postoperatively | rate of hospital readmission |
| need of abdomen CTscan rate | 30 days postoperatively | need of abdomen CTscan |
| Mortality rate | 90 days postoperatively | postoperative mortality |
| White blood cell | 30 days postoperatively | measured thousands/mL in I and III POD |
| Anastomotic leak rate | 30 days postoperatively | postoperative Ileocolic anastomotic leakage |
| Tolerance to liquid diet | 30 days postoperatively | time to clear fluid tolerance |
| Time to first flatus | 30 days postoperatively | Time to first flatus postoperatively |
| Time to first evacuation | 30 days postoperatively | Time to first evacuation postoperatively |
| C-Reactive Proteine | 30 days postoperatively | measured mg/L in I and III POD |
| Surgical site infection rate | 30 days postoperatively | postoperative wound infection |
Countries
Italy
Outcome results
None listed