An Early Phase 1 interventional study of abdominal drainage and Postoperative antibiotico-prophylaxis in Colon Cancer, sponsored by University of Rome Tor Vergata. Completed at 1 site in Italy. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2023-11-22.
Sponsored by University of Rome Tor Vergata · Early Phase 1, Interventional, and Treatment
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.
1,432 studies on the registry are indexed under Colonic Neoplasms; 357 are open to participants now.
This study's enrollment of 36 is below the median of 90 across 1,034 interventional studies indexed under Colonic Neoplasms.
Browse Colonic Neoplasms studies →University of Rome Tor Vergata is the lead sponsor of 94 studies on the registry; 20 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
19 Fr abdominal drainage placed intraoperatevely in right paracolic gutter
Procedure: abdominal drainage · Procedure: Laparoscopic radical right colectomy with CME and D3 lymphadenectomy (RRC) · Procedure: Laparoscopic standard D2 right hemicolectomy (STANDARD)
postoperative antibiotico-prophylaxis with Ceftriaxone 2gr and Metronidazole 1.5gr
Drug: Postoperative antibiotico-prophylaxis · Procedure: Laparoscopic radical right colectomy with CME and D3 lymphadenectomy (RRC) · Procedure: Laparoscopic standard D2 right hemicolectomy (STANDARD)
No drainage nor postoperative antibiotico-prophylaxis
Procedure: Laparoscopic radical right colectomy with CME and D3 lymphadenectomy (RRC) · Procedure: Laparoscopic standard D2 right hemicolectomy (STANDARD)
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
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
This study is completed, as verified in Nov 2023. You cannot join it, but the record below documents what was studied.
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University of Rome Tor Vergata