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

University of Rome Tor Vergata

Status and phase: Completed; Early Phase 1

Conditions: Colon Cancer

Treatments: Procedure: abdominal drainage; Procedure: Laparoscopic standard D2 right hemicolectomy (STANDARD); Procedure: Laparoscopic radical right colectomy with CME and D3 lymphadenectomy (RRC); Drug: Postoperative antibiotico-prophylaxis

Study type: Interventional

Funder types: Other

Identifiers

NCT04977882

Registro sperimentazioni XX.21

Details and patient eligibility

About

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.

Enrollment: 36 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Factorial Assignment

Masking: None (Open label)

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36 participants in 3 patient groups

Abdominal drainage

Experimental group

Description:

19 Fr abdominal drainage placed intraoperatevely in right paracolic gutter

Treatment:

Procedure: Laparoscopic standard D2 right hemicolectomy (STANDARD)

Procedure: abdominal drainage

Procedure: Laparoscopic radical right colectomy with CME and D3 lymphadenectomy (RRC)

Postoperative antibiotico-prophylaxis

Experimental group

Description:

postoperative antibiotico-prophylaxis with Ceftriaxone 2gr and Metronidazole 1.5gr

Treatment:

Drug: Postoperative antibiotico-prophylaxis

Procedure: Laparoscopic standard D2 right hemicolectomy (STANDARD)

Procedure: Laparoscopic radical right colectomy with CME and D3 lymphadenectomy (RRC)

Control group

Sham Comparator group

Description:

No drainage nor postoperative antibiotico-prophylaxis

Treatment:

Procedure: Laparoscopic standard D2 right hemicolectomy (STANDARD)

Procedure: Laparoscopic radical right colectomy with CME and D3 lymphadenectomy (RRC)