Physical Recovery After Laparoscopic vs. Open Liver Resection

Not Applicable

Completed

• Conditions: Postoperative Complications; Liver Diseases; Physical Stress; Surgery
• Interventions: Other: Ergometry

• Registration Number: NCT04067349
• Lead Sponsor: Medical University of Vienna

Brief Summary

The role of laparoscopic liver surgery with respect to clinical outcome remains unclear.

Detailed Description

The role of laparoscopic liver surgery with respect to clinical outcome remains unclear. The investigators hypothesized that laparoscopic liver resection (LLR) is associated with better postoperative recovery than open liver resection (OLR).

Twenty-one patients who underwent LR were included in this study (11 OLR (52.4%) and 10 LLR (47.6%), respectively). Postoperative recovery was measured by bicycle stress testing at months 1 and 6 after surgery and compared to preoperative stress testing. Standardized performance for bicycle stress testing was calculated based on age, sex, height and weight. Postoperative recovery was compared between groups as change of performance (%).

Study Timeline

• Study Start: 2017-04-06
• Primary Completion: 2018-08-08
• Study Completion: 2019-04-14
• Status Verified: 2019-08
• Study First Submitted: 2019-08-21
• Study First Submitted QC: 2019-08-22
• Last Update Submitted: 2019-08-22
• Study First Posted: 2019-08-26
• Last Update Posted: 2019-08-26

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 21

Inclusion Criteria

• all patients undergoing liver resection (open vs. laparoscopic)
• all patients willing participate and gave written informed consent

Read More

Exclusion Criteria

• pregnancy
• significant traumatic injury within 30 days prior to study enrolment
• inability or unwillingness to comply to the protocol or to perform bicycle ergometry

Read More

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
open liver resection	Ergometry	Patients undergoing open liver resection
laparoscopic liver resection	Ergometry	Patients undergoing laparoscopic liver resection

Primary Outcome Measures

Name	Time	Method
Overall change in performance	1, 6 months	The change in performance after 1 and 6 months postoperatively in comparison to preoperative ergometry.

Secondary Outcome Measures

Name	Time	Method
Postoperative Complications	1 months	Secondary endpoints included postoperative complications (wound healing, liver failure, adverse events)
Liver resection and effect on postoperative fitness	2 years	patients were divided into two groups ( major (\>2 segments) vs. minor (≤2segments) liver resection) and postoperative performance was evaluated
length of stay	1 month	Length of postoperative hospital stay

Trial Locations

Locations (1)

Medical University of Vienna, Department of Surgery; 🇦🇹 Vienna, Austria