A randomised controlled trial of optimised surgical recovery after left lateral hepatic sectionectomy: open versus laparoscopic surgery within an enhanced recovery programme.

A randomised controlled trial of optimised surgical recovery after left lateral hepatic sectionectomy: open versus laparoscopic surgery within an enhanced recovery programme. - ORANGE II trial

Status

Recruiting

Phases

Unknown

Study type

Interventional

Source

NL-OMON

Registry ID

NL-OMON39869

Enrollment

110

Registered

2009-03-13

Start date

2009-11-01

Completion date

Unknown

Last updated

2024-05-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Functional recovery after hepatectomy

Interventions

The ORANGE II * Trial investigates whether the open or laparoscopic procedure is superior in patient undergoing a segment 2-3 resection (left lateral sectionectomy). This will be expressed by a shor

Eligibility

Age

18 Years to 99 Years

Inclusion criteria

Inclusion criteria: - Patients undergoing left lateral hepatic sectionectomy. - 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

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

Design outcomes

Secondary

Measure	Time frame
1. Total postoperative length of hospital stay 2. Readmission percentage 3. Total morbidity 4. Liver specific morbidity 5. Quality of life 6. Body image and cosmesis 7. Hospital costs 8. Long term incidence of incisional hernias 9. Reasons for delay in discharge after fucntional recovery	—

Primary

Measure	Time frame
1. Time to functional recovery	—

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)