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Completed

NCT Number: NCT04977882

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Early Phase 1

Primary location

University of Rome Tor Vergata

Rome, 00133, Italy

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

abdominal drainage

Procedure

19 Fr abdominal drainage placed intraoperatively in right colic gutter

Postoperative antibiotico-prophylaxis

Drug

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

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.

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

Primary outcomes

  1. Tolerance to solid diet

    Time frame: 30 days postoperatively

    time to light diet tolerance

Secondary outcomes

  1. White blood cell

    Time frame: 30 days postoperatively

    measured thousands/mL in I and III POD

  2. Procalcitonine

    Time frame: 30 days postoperatively

    measured ng/ml in III and V POD

  3. Days of hospitalization

    Time frame: 90 days postoperatively

    number of days of hospitalization

  4. Readmission rate

    Time frame: 90 days postoperatively

    rate of hospital readmission

  5. Mortality rate

    Time frame: 90 days postoperatively

    postoperative mortality

  6. Surgical site infection rate

    Time frame: 30 days postoperatively

    postoperative wound infection

  7. Anastomotic leak rate

    Time frame: 30 days postoperatively

    postoperative Ileocolic anastomotic leakage

  8. Tolerance to liquid diet

    Time frame: 30 days postoperatively

    time to clear fluid tolerance

  9. Time to first flatus

    Time frame: 30 days postoperatively

    Time to first flatus postoperatively

  10. Time to first evacuation

    Time frame: 30 days postoperatively

    Time to first evacuation postoperatively

  11. need of abdomen CTscan rate

    Time frame: 30 days postoperatively

    need of abdomen CTscan

  12. C-Reactive Proteine

    Time frame: 30 days postoperatively

    measured mg/L in I and III POD

Sponsors and collaborators

Lead sponsor

University of Rome Tor Vergata

Other

Registry information

Important dates

Study start
2020
Primary completion
2022
Study completion
2023
First posted
Jul 27, 2021
Registry last updated
Nov 22, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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