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

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 Overview

• Status: Completed
• Conditions: Colon Cancer
• Intervention / Treatment: Procedure: abdominal drainage; Drug: Postoperative antibiotico-prophylaxis; Procedure: Laparoscopic radical right colectomy with CME and D3 lymphadenectomy (RRC); Procedure: Laparoscopic standard D2 right hemicolectomy (STANDARD)

• Study Type: Interventional
• Enrollment (Actual): 36
• Phase: Early Phase 1

Contacts and Locations

Study Locations

• Italy
  • Rome, Italy, 00133
    • University of Rome Tor Vergata

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Factorial Assignment
• Masking: None (Open Label)

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Abdominal drainage; 19 Fr abdominal drainage placed intraoperatevely in right paracolic gutter	Procedure: abdominal drainage; 19 Fr abdominal drainage placed intraoperatively in right colic gutter; 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.; Procedure: 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
Experimental: Postoperative antibiotico-prophylaxis; postoperative antibiotico-prophylaxis with Ceftriaxone 2gr and Metronidazole 1.5gr	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.; Procedure: 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
Sham Comparator: Control group; No drainage nor postoperative antibiotico-prophylaxis	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.; Procedure: 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Tolerance to solid diet	time to light diet tolerance	30 days postoperatively

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: University of Rome Tor Vergata

Study record dates

Study Major Dates

• Study Start (Actual): October 1, 2020
• Primary Completion (Actual): August 1, 2022
• Study Completion (Actual): August 1, 2023

Study Registration Dates

• First Submitted: July 15, 2021
• First Submitted That Met QC Criteria: July 25, 2021
• First Posted (Actual): July 27, 2021

Study Record Updates

• Last Update Posted (Estimated): November 22, 2023
• Last Update Submitted That Met QC Criteria: November 20, 2023
• Last Verified: November 1, 2023

More Information

Terms related to this study

• Keywords: colon cancer; intracorporeal anastomosis; right hemicoletomy
• Additional Relevant MeSH Terms: Digestive System Diseases; Neoplasms; Neoplasms by Site; Gastrointestinal Neoplasms; Digestive System Neoplasms; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Intestinal Neoplasms; Colorectal Neoplasms; Colonic Neoplasms
• Other Study ID Numbers: Registro sperimentazioni XX.21

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No