About this trial
The rationale for this study is to evaluate whether a standardized, preoperative, short-term Low Calorie Diet (LCD) reduces intraoperative bleeding and postoperative morbidity in liver surgery.
Participants with a BMI of 30 or higher, scheduled for liver surgery, if accepting participation, will be randomized to a 7 day LCD or no intervention.
A previous small single center RCT have shown significantly reduced intraoperative blood loss and a tendency towards less postoperative complications. This multi-centre study aims to include enough patients with power to analyze also postoperative complications.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Scheduled for open or minimally invasive liver resection
BMI ≥30
Disqualifiers
Diagnosed liver cirrhosis
Perihilar tumours
Inability to understand written information in Swedish, Norwegian, Danish, or English
Trial design
Parallel
Treatments tested in this trial
Low calorie meal replacement plan
Dietary supplementShort-term LCD one week prio to liver surgery for patients with a BMI 30 or higher
Treatment groups
Trial outcomes
Primary outcomes
Postoperative complications
To investigate whether a 7-day preoperative LCD reduces postoperative complications as measured by the Comprehensive Complication Index (CCI). CCI=0 means no complications and CCI=100 means death.
Bleeding
Total intraoperative bleeding measured in millilitres
Secondary outcomes
Operating time
To investigate whether there is a difference in in total operating time measured in minutes including liver mobilisation and parenchymal dissection time specified.
Length of hospital stay (LOS - from the day of surgery until discharge from the hospital)
To compare LOS measured in days between the groups
Radical resection (R0)
Investigate if there is a difference in R0 between the intervention and control group. R0 defined as \>1 mm tumor free margins.
Health-related quality of life (QoL)
Health-related QoL measured by QLQ-C30
Sponsors and contacts
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