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

Colon Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04977882
• Other study ID #: Registro sperimentazioni XX.21
• Status: Completed
• Phase: Early Phase 1
• Start date: October 1, 2020
• Est. completion date: August 1, 2023

Study information

• Verified date: November 2023
• Source: University of Rome Tor Vergata
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 36
• Est. completion date: August 1, 2023
• Est. primary completion date: August 1, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Colon Cancer
• Colonic Neoplasms

Intervention

Procedure:
• abdominal drainage
19 Fr abdominal drainage placed intraoperatively in right colic gutter

Drug:
• Postoperative antibiotico-prophylaxis
Ceftriaxone 2 gr and Metronidazole 1.5 gr per day for 2 days postoperatively

Procedure:
• 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.
• 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

Locations

Country	Name	City	State
Italy	University of Rome Tor Vergata	Rome

Sponsors (1)

Lead Sponsor	Collaborator
University of Rome Tor Vergata

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Tolerance to solid diet	time to light diet tolerance	30 days postoperatively
Secondary	White blood cell	measured thousands/mL in I and III POD	30 days postoperatively
Secondary	Procalcitonine	measured ng/ml in III and V POD	30 days postoperatively
Secondary	Days of hospitalization	number of days of hospitalization	90 days postoperatively
Secondary	Readmission rate	rate of hospital readmission	90 days postoperatively
Secondary	Mortality rate	postoperative mortality	90 days postoperatively
Secondary	Surgical site infection rate	postoperative wound infection	30 days postoperatively
Secondary	Anastomotic leak rate	postoperative Ileocolic anastomotic leakage	30 days postoperatively
Secondary	Tolerance to liquid diet	time to clear fluid tolerance	30 days postoperatively
Secondary	Time to first flatus	Time to first flatus postoperatively	30 days postoperatively
Secondary	Time to first evacuation	Time to first evacuation postoperatively	30 days postoperatively
Secondary	need of abdomen CTscan rate	need of abdomen CTscan	30 days postoperatively
Secondary	C-Reactive Proteine	measured mg/L in I and III POD	30 days postoperatively