Clinical trial · Interventional
Surgical Recovery After Left Lateral Hepatic Sectionectomy: Laparoscopic Versus Open Surgery.
The ORANGE II Trial: An International Multicenter Randomised Controlled Trial of Optimised Surgical Recovery After Left Lateral Hepatic Sectionectomy: Open Versus Laparoscopic Surgery Within an Enhanced Recovery Programme
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (3)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Colorectal Cancer | Malignant Colorectal Neoplasm | CURATED_BROADER | 0.80 |
| Liver Disease | — | UNRESOLVED | — |
| Liver Metastasis | — | UNRESOLVED | — |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| laparoscopic left lateral hepatic sectionectomy | Procedure | — | UNRESOLVED |
| open left lateral hepatic sectionectomy | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (3)
- type
- ACTIVE_COMPARATOR
- label
- 1
- description
- patients undergoing open left lateral hepatic sectionectomy
- interventionNames
- Procedure: open left lateral hepatic sectionectomy
- type
- ACTIVE_COMPARATOR
- label
- 2
- description
- patients undergoing a laparoscopic left lateral hepatic sectionectomy
- interventionNames
- Procedure: laparoscopic left lateral hepatic sectionectomy
- type
- ACTIVE_COMPARATOR
- label
- 3
- description
- Prospective registry of patients that cannot be randomized (both open and laparoscopic left lateral hepatic sectionectomy)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 80 Years
Show eligibility criteria text
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
References
Publications (2)
- DERIVEDWong-Lun-Hing EM, van Dam RM, van Breukelen GJ, Tanis PJ, Ratti F, van Hillegersberg R, Slooter GD, de Wilt JH, Liem MS, de Boer MT, Klaase JM, Neumann UP, Aldrighetti LA, Dejong CH; ORANGE II Collaborative Group. Randomized clinical trial of open versus laparoscopic left lateral hepatic sectionectomy within an enhanced recovery after surgery programme (ORANGE II study). Br J Surg. 2017 Apr;104(5):525-535. doi: 10.1002/bjs.10438. Epub 2017 Jan 31. PMID 28138958
- DERIVEDvan Dam RM, Wong-Lun-Hing EM, van Breukelen GJ, Stoot JH, van der Vorst JR, Bemelmans MH, Olde Damink SW, Lassen K, Dejong CH; ORANGE II Study Group. Open versus laparoscopic left lateral hepatic sectionectomy within an enhanced recovery ERAS(R) programme (ORANGE II-trial): study protocol for a randomised controlled trial. Trials. 2012 May 6;13:54. doi: 10.1186/1745-6215-13-54. PMID 22559239