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

NCT04977882 | Completed Early Phase 1

• 1 other identifier: Registro sperimentazioni XX.21
• Study Type: interventional
• Target: 36
• Locations: 1 country
• Sites: 1

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.

Conditions

Colon Cancer

Keywords

intracorporeal anastomosis; right hemicoletomy; colon cancer

Outcome Measures

Primary Outcomes (1)

• Tolerance to solid diet

  time to light diet tolerance

  30 days postoperatively

Secondary Outcomes (12)

• White blood cell

  30 days postoperatively

• Procalcitonine

  30 days postoperatively

• Days of hospitalization

  90 days postoperatively

• Readmission rate

  90 days postoperatively

• Mortality rate

  90 days postoperatively

Study Arms (3)

Abdominal drainage

EXPERIMENTAL

19 Fr abdominal drainage placed intraoperatevely in right paracolic gutter

Procedure: abdominal drainage; Procedure: Laparoscopic radical right colectomy with CME and D3 lymphadenectomy (RRC); Procedure: Laparoscopic standard D2 right hemicolectomy (STANDARD)

Postoperative antibiotico-prophylaxis

EXPERIMENTAL

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

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

Control group

SHAM COMPARATOR

No drainage nor postoperative antibiotico-prophylaxis

Procedure: Laparoscopic radical right colectomy with CME and D3 lymphadenectomy (RRC); Procedure: Laparoscopic standard D2 right hemicolectomy (STANDARD)

Interventions

abdominal drainage PROCEDURE

19 Fr abdominal drainage placed intraoperatively in right colic gutter

Abdominal drainage

Postoperative antibiotico-prophylaxis DRUG

Ceftriaxone 2 gr and Metronidazole 1.5 gr per day for 2 days postoperatively

Postoperative antibiotico-prophylaxis

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

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.

Abdominal drainage; Control group; Postoperative antibiotico-prophylaxis

Laparoscopic standard D2 right hemicolectomy (STANDARD) PROCEDURE

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

Abdominal drainage; Control group; Postoperative antibiotico-prophylaxis

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Right colon cancer
• Intracorporeal anastomosis
• Laparoscopic surgery
• Elective surgery
• informed consent signed

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Rome Tor Vergata: lead

Study Sites (1)

University of Rome Tor Vergata

Rome, 00133, Italy

Location

Related Publications (1)

• Sica GS, Siragusa L, Pirozzi BM, Sorge R, Baldini G, Fiorani C, Guida AM, Bellato V, Franceschilli M. Gastrointestinal functions after laparoscopic right colectomy with intracorporeal anastomosis: a pilot randomized clinical trial on effects of abdominal drain, prolonged antibiotic prophylaxis, and D3 lymphadenectomy with complete mesocolic excision. Int J Colorectal Dis. 2024 Jul 6;39(1):102. doi: 10.1007/s00384-024-04657-0.

  PMID: 38970713 DERIVED

MeSH Terms

Conditions

Colonic Neoplasms

Condition Hierarchy (Ancestors)

Colorectal Neoplasms; Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: FACTORIAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Head of Minimally Invasive Surgery Unit

Model Details: 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).

Study Record Dates

• First Submitted: July 15, 2021
• First Posted: July 27, 2021
• Study Start: October 1, 2020
• Primary Completion: August 1, 2022
• Study Completion: August 1, 2023
• Last Updated: November 22, 2023

Record last verified: 2023-11

Locations

IT (1)