Surgical Recovery After Left Lateral Hepatic Sectionectomy: Laparoscopic Versus Open Surgery.

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

110 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-01-31

Study Completion Date

2014-07-31

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Colorectal Cancer Liver Metastasis Liver Disease

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Caregivers

Study Groups

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1

patients undergoing open left lateral hepatic sectionectomy

Group Type ACTIVE_COMPARATOR

open left lateral hepatic sectionectomy

Intervention Type PROCEDURE

open left lateral hepatic sectionectomy

2

patients undergoing a laparoscopic left lateral hepatic sectionectomy

Group Type ACTIVE_COMPARATOR

laparoscopic left lateral hepatic sectionectomy

Intervention Type PROCEDURE

laparoscopic left lateral hepatic sectionectomy

3

Prospective registry of patients that cannot be randomized (both open and laparoscopic left lateral hepatic sectionectomy)

Group Type ACTIVE_COMPARATOR

laparoscopic left lateral hepatic sectionectomy

Intervention Type PROCEDURE

laparoscopic left lateral hepatic sectionectomy

open left lateral hepatic sectionectomy

Intervention Type PROCEDURE

open left lateral hepatic sectionectomy

Interventions

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laparoscopic left lateral hepatic sectionectomy

Intervention Type PROCEDURE

open left lateral hepatic sectionectomy

Intervention Type PROCEDURE

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes