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

Early Phase 1

Completed

• Conditions: Colon Cancer
• Interventions: 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)

• Registration Number: NCT04977882
• Lead Sponsor: University of Rome Tor Vergata

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2020-10-01
• Study First Submitted: 2021-07-15
• Study First Submitted QC: 2021-07-25
• Study First Posted: 2021-07-27
• Primary Completion: 2022-08-01
• Study Completion: 2023-08-01
• Status Verified: 2023-11
• Last Update Submitted: 2023-11-20
• Last Update Posted: 2023-11-22

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 36

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: FACTORIAL

Arm && Interventions

Group	Intervention	Description
Postoperative antibiotico-prophylaxis	Laparoscopic standard D2 right hemicolectomy (STANDARD)	postoperative antibiotico-prophylaxis with Ceftriaxone 2gr and Metronidazole 1.5gr
Abdominal drainage	abdominal drainage	19 Fr abdominal drainage placed intraoperatevely in right paracolic gutter
Abdominal drainage	Laparoscopic standard D2 right hemicolectomy (STANDARD)	19 Fr abdominal drainage placed intraoperatevely in right paracolic gutter
Abdominal drainage	Laparoscopic radical right colectomy with CME and D3 lymphadenectomy (RRC)	19 Fr abdominal drainage placed intraoperatevely in right paracolic gutter
Postoperative antibiotico-prophylaxis	Postoperative antibiotico-prophylaxis	postoperative antibiotico-prophylaxis with Ceftriaxone 2gr and Metronidazole 1.5gr
Postoperative antibiotico-prophylaxis	Laparoscopic radical right colectomy with CME and D3 lymphadenectomy (RRC)	postoperative antibiotico-prophylaxis with Ceftriaxone 2gr and Metronidazole 1.5gr
Control group	Laparoscopic radical right colectomy with CME and D3 lymphadenectomy (RRC)	No drainage nor postoperative antibiotico-prophylaxis
Control group	Laparoscopic standard D2 right hemicolectomy (STANDARD)	No drainage nor postoperative antibiotico-prophylaxis

Primary Outcome Measures

Name	Time	Method
Tolerance to solid diet	30 days postoperatively	time to light diet tolerance

Secondary Outcome Measures

Name	Time	Method
Time to first evacuation	30 days postoperatively	Time to first evacuation postoperatively
White blood cell	30 days postoperatively	measured thousands/mL in I and III POD
Mortality rate	90 days postoperatively	postoperative mortality
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
Surgical site infection rate	30 days postoperatively	postoperative wound infection
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
need of abdomen CTscan rate	30 days postoperatively	need of abdomen CTscan
C-Reactive Proteine	30 days postoperatively	measured mg/L in I and III POD

Trial Locations

Locations (1)

University of Rome Tor Vergata; 🇮🇹 Rome, Italy