Clinical trial
Abdominal Drainage, Postoperative Antibiotico-prophylaxis and CME With D3 Lyphadenectomy Effect on Gastrointestinal Function in Laparoscopic Right Hemicolectomy With Intracorporeal Anastomosis for Right Colon Cancer
Name
Registro sperimentazioni XX.21
Description
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.
Trial arms
Trial start
2020-10-01
Estimated PCD
2022-08-01
Trial end
2023-08-01
Status
Completed
Phase
Early phase I
Treatment
abdominal drainage
19 Fr abdominal drainage placed intraoperatively in right colic gutter
Arms:
Abdominal drainage
Postoperative antibiotico-prophylaxis
Ceftriaxone 2 gr and Metronidazole 1.5 gr per day for 2 days postoperatively
Arms:
Postoperative antibiotico-prophylaxis
Laparoscopic 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.
Arms:
Abdominal drainage, Control group, Postoperative antibiotico-prophylaxis
Laparoscopic 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
Arms:
Abdominal drainage, Control group, Postoperative antibiotico-prophylaxis
Size
36
Primary endpoint
Tolerance to solid diet
30 days postoperatively
Eligibility criteria
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
Protocol
{'studyType': 'INTERVENTIONAL', 'phases': ['EARLY_PHASE1'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'FACTORIAL', 'interventionModelDescription': '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).', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'NONE'}}, 'enrollmentInfo': {'count': 36, 'type': 'ACTUAL'}}
Updated at
2023-11-22
1 organization
Organization
University of Rome Tor Vergata