Surgical Recovery After Left Lateral Hepatic Sectionectomy: Laparoscopic Versus Open Surgery. (ORANGE II)

Maastricht University Medical Centre (MUMC) logo

Maastricht University Medical Centre (MUMC)

Status

Completed

Conditions

Liver Metastasis
Liver Disease
Colorectal Cancer

Treatments

Procedure: open left lateral hepatic sectionectomy
Procedure: laparoscopic left lateral hepatic sectionectomy

Study type

Interventional

Funder types

Other

Identifiers

NCT00874224
MEC 08-2-110

Details and patient eligibility

About

The ORANGE II trial is a double blinded randomised controlled trial that will provide evidence on the merits of laparoscopic surgery in patients undergoing a left lateral hepatic sectionectomy in terms of time to functional recovery, hospital length of stay, quality of life, readmission percentage, morbidity and mortality, hospital costs, body image and cosmesis, and long term incidence of incisional hernias.

Full description

Recent developments in liver surgery include the introduction of laparoscopic surgery and enhanced recovery programmes. Laparoscopic surgery and enhanced recovery programmes both focus on faster recovery and consequently shorter hospital length of stay. The ORANGE-II trial is a prospective randomised controlled parallel group superiority trial with a double-blinded experimental and a prospective registry design to determine whether laparoscopic surgery is to be preferred over open surgery in patients undergoing a left lateral hepatic sectionectomy within an enhanced recovery programme. The experimental design produces two randomised arms; (a) open LLS and (b) laparoscopic LLS. An additional registry arm will be based on surgeons/patients that do not want to be randomised because they have an explicit preference for either the laparoscopic LLS or for the open LLS (c). The primary endpoint of the ORANGE II trial is time to functional recovery. The functional recovery criteria consist of adequate pain control with oral analgetics only, mobility restored to an independent level, absence of intravenous fluid administration, ability to eat solid foods and finally a normal or decreasing serum bilirubin level. A patient is fully functionally recovered when all of the five criteria are satisfied. Secondary endpoints of this trial are postoperative length of hospital stay, readmission percentage, (liver specific) morbidity, quality of life, body image and cosmetic result, hospital and societal costs during one year and long-term incidence of incisional hernias. The ORANGE-II trial is a randomised controlled multicentre trial that will provide evidence on the merits of laparoscopic surgery in patients undergoing a left lateral hepatic sectionectomy and participating in an enhanced recovery programme.

Enrollment

110 estimated patients

Sex

All

Ages

18 to 80 years old

Volunteers

Accepts Healthy Volunteers

Inclusion criteria

  • Patients suitable for undergoing both laparoscopic left lateral sectionectomy as well as open left lateral sectionectomy of the liver.
  • Able to understand the nature of the study and what will be required of them.
  • Men and non-pregnant, non-lactating women between age 18-80.
  • BMI between 18-35.
  • Patients with ASA I-II-III

Exclusion criteria

  • Inability to give written informed consent.
  • Patients undergoing liver resection other than left lateral hepatic sectionectomy.
  • Patients with ASA IV-V
  • Underlying liver disease

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Double Blind

110 participants in 3 patient groups

1
Active Comparator group
Description:
patients undergoing open left lateral hepatic sectionectomy
Treatment:
Procedure: open left lateral hepatic sectionectomy
2
Active Comparator group
Description:
patients undergoing a laparoscopic left lateral hepatic sectionectomy
Treatment:
Procedure: laparoscopic left lateral hepatic sectionectomy
3
Active Comparator group
Description:
Prospective registry of patients that cannot be randomized (both open and laparoscopic left lateral hepatic sectionectomy)
Treatment:
Procedure: laparoscopic left lateral hepatic sectionectomy
Procedure: open left lateral hepatic sectionectomy

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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