Physical Recovery After Laparoscopic vs. Open Liver Resection

Surgery Clinical Trial

Official title:

Physical Recovery After Laparoscopic vs. Open Liver Resection - a Pilot Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04067349
• Other study ID #: 1829/2016)
• Status: Completed
• Phase: N/A
• Start date: April 6, 2017
• Est. completion date: April 14, 2019

Study information

• Verified date: August 2019
• Source: Medical University of Vienna
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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 (%).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 21
• Est. completion date: April 14, 2019
• Est. primary completion date: August 8, 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: N/A and older

Eligibility

Inclusion Criteria:

• all patients undergoing liver resection (open vs. laparoscopic)

• all patients willing participate and gave written informed consent

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

Related Conditions & MeSH terms

• Liver Diseases
• Physical Stress
• Postoperative Complications
• Surgery

Intervention

Other:
• Ergometry
Patients underwent a preoperative ergometry to assess their physical fitness prior to their planned liver resection. Bicycle stress testing was performed preoperatively and 1 and 6 months postoperatively.

Locations

Country	Name	City	State
Austria	Medical University of Vienna, Department of Surgery	Vienna

Sponsors (1)

Lead Sponsor	Collaborator
Medical University of Vienna

Country where clinical trial is conducted

Austria, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Overall change in performance	The change in performance after 1 and 6 months postoperatively in comparison to preoperative ergometry.	1, 6 months
Secondary	Postoperative Complications	Secondary endpoints included postoperative complications (wound healing, liver failure, adverse events)	1 months
Secondary	Liver resection and effect on postoperative fitness	patients were divided into two groups ( major (>2 segments) vs. minor (=2segments) liver resection) and postoperative performance was evaluated	2 years
Secondary	length of stay	Length of postoperative hospital stay	1 month