To Evaluate If Preoperative 7 Days Low Calorie Diet Reduces Postoperative Morbidity in Liver Surgery

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorRegion Skane

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 volunteers

Qualifiers

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

Design model

Parallel

Treatments tested in this trial

  • Low calorie meal replacement plan

    Dietary supplement

    Short-term LCD one week prio to liver surgery for patients with a BMI 30 or higher

Treatment groups

200 Participants
are divided into 2 treatment groups
Group A: StandardNo intervention 0 interventions
Group B: InterventionExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

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.

Time frame
From 1 week before to 30 days after liver surgery
2

Bleeding

Total intraoperative bleeding measured in millilitres

Time frame
During liver surgery

Secondary outcomes

1

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.

Time frame
During liver surgery
2

Length of hospital stay (LOS - from the day of surgery until discharge from the hospital)

To compare LOS measured in days between the groups

Time frame
From the day before surgery until 90 days postoperatively
3

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.

Time frame
From surgery until definitive pathological report is documented in the medical records, ie an average of 3-12 weeks
4

Health-related quality of life (QoL)

Health-related QoL measured by QLQ-C30

Time frame
Preoperatively and 30 days postoperatively

Other outcomes

Sponsors and contacts

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