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OpenTrials
Completed

NCT Number: NCT04067349

Physical Recovery After Laparoscopic vs. Open Liver Resection

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

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Key information

Conditions

Postoperative Complications Digestive System Diseases Liver Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms Physical Stress Surgery

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Medical University of Vienna, Department of Surgery

Vienna, 1090, Austria

About this study

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 (%).

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Ergometry

Other

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.

Primary outcomes

  1. Overall change in performance

    Time frame: 1, 6 months

    The change in performance after 1 and 6 months postoperatively in comparison to preoperative ergometry.

Secondary outcomes

  1. Postoperative Complications

    Time frame: 1 months

    Secondary endpoints included postoperative complications (wound healing, liver failure, adverse events)

  2. Liver resection and effect on postoperative fitness

    Time frame: 2 years

    patients were divided into two groups ( major (>2 segments) vs. minor (≤2segments) liver resection) and postoperative performance was evaluated

  3. length of stay

    Time frame: 1 month

    Length of postoperative hospital stay

Sponsors and collaborators

Lead sponsor

Medical University of Vienna

Other

Registry information

Official study title

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

Important dates

Study start
2017
Primary completion
2018
Study completion
2019
First posted
Aug 26, 2019
Registry last updated
Aug 26, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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