Surgical ComplicationsLowCaLiNCT07801716
To Evaluate If Preoperative 7 Days Low Calorie Diet Reduces Postoperative Morbidity in Liver Surgery
A study testing Low calorie meal replacement plan in people with Surgical Complications, run by Region Skane at 1 site in Sweden.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Surgical Complications
- What is being tested?
- Low calorie meal replacement plan
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- 1 siteSweden
- Study dates
- 1 Jun 2026to 1 Jul 2029
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Scheduled for open or minimally invasive liver resection
- BMI ≥30
Who cannot join
- Diagnosed liver cirrhosis
- Perihilar tumours
- Inability to understand written information in Swedish, Norwegian, Danish, or English
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Helena Taflin, MD, PhD contact
Sweden1 site, 1 recruiting
- Recruiting
Department och Surgery, Skane University Hospital
Lund, 22185
Jenny Lundmark Rystedt, MD, PhD, +46 46 171899, jenny.lundmarkrystedt@skane.se
Caroline Williamsson, MD, PhD, +46 46 176253, caroline.williamsson@skane.se
About this study
Official title: Low Calorie Diet Before Liver Surgery - A Nordic Multicentre Randomized Controlled 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.
Read the detailed description
The LowCaLi study is a multicentre, open-label, randomized controlled trial.
Hypothesis
- A 7-day preoperative LCD reduces postoperative complications.
- LCD reduces intraoperative bleeding and postoperative complication rate.
- LCD reduces liver volume, facilitates access, and shortens operating time.
- LCD decreases hepatic glycogen and steatosis.
- LCD improves coagulation.
- LCD modifies plasma lipid and fatty acid composition.
Primary Objective To investigate whether a 7-day preoperative LCD reduces postoperative complications as measured by the Comprehensive Complication Index (CCI).
Secondary Objectives
- To assess the effect of LCD on intraoperative blood loss and transfusion requirements.
- To evaluate parenchymal dissection time and total surgical duration.
- To measure hospital length of stay.
- To determine R0 resection rate (tumour-free margins).
- To analyse systemic inflammatory response.
- To evaluate compliance with the intervention.
- To assess health-related quality of life (QLQ-C30).
Sample Size Calculation Barth et al. (2019) demonstrated a reduction in bleeding from 300 ml to 200 ml with LCD, requiring 32 patients for 80% power at α=0.05. For CCI reduction (21→13, SD=20), 98 patients per arm are required. To account for attrition, 200 patients (100 per group) will be recruited.
Study Procedures
- Screening and randomization at preoperative visit
- LCD intervention: 7 days prior to surgery
- Follow-up phone calls during the intervention period
- Structured intraoperative assessment by surgeon
- Postoperative follow-up including complications, pathology, and length of stay
- Patient-reported outcomes collected preoperatively and at 30 days postoperatively
Workflow Eligible patients will be identified during the mandatory pre-surgery outpatient visit. Written and oral study information will be provided, and informed consent obtained. Patients will then be randomized (1:1) using a web-based module in the eCRF (RedCap).
Randomization will be stratified by surgical approach (open vs. minimally invasive). The intervention group will follow a 7-day LCD (1000 kcal/day), using a standardized commercial product such as for example Modifast). The control group will receive standard preoperative care, including carbohydrate preloading, without diet restriction.
Study nurses will provide dietary instructions and monitor compliance through scheduled phone calls. Following surgery, the operating surgeon will complete a structured form documenting liver mobility, parenchymal texture, and intraoperative blood loss. Patient-reported quality of life will be assessed preoperatively and 30 days postoperatively.
Withdrawal of Individual Subjects Participation is voluntary. Patients may withdraw at any time without consequences for clinical care.
Follow-up of Subjects Withdrawn from Treatment Data collected up to the time of withdrawal will be included if the patient consents.
Statistical Analysis Primary analysis: comparison of CCI between groups using t-test or Mann-Whitney U test. Secondary analyses: regression models for continuous outcomes, chi-square/Fisher's exact tests for categorical data, and Kaplan-Meier analysis for time-to-event outcomes. Both intention-to-treat and per-protocol analyses will be performed.
ETHICAL CONSIDERATIONS Regulation Statement: The study will be conducted in accordance with the Declaration of Helsinki, ICH-GCP, and national legislation. Recruitment and Consent: To avoid bias, brief study information will be given to all eligible patients before randomization. Full dietary details will only be disclosed to participants allocated to the intervention group. Written informed consent is required prior to enrolment. The intervention group will be recieve LCD för 7 days or be compensated for the extra cost due to LCD diet, in arrears.
Compensation for Injury Patients are covered by national patient insurance schemes. No monetary compensation will be provided to participants.
ADMINISTRATIVE ASPECTS, MONITORING AND PUBLICATION Handling and storage of data and documents The sponsor and the trial management team will oversee the conduct of the trial according to Good Clinical Practice (GCP). The local investigators will be responsible for conduct at their respective sites.
Data will be handled confidentially. Each patient will receive an anonymous identification code. To trace data, a subject identification code list will be used. Each participating site will keep the key to this code secure. The handling of data will comply with the EU General Data Protection Regulation (GDPR).
Data will be kept for a minimum of ten years according to current regulations. Data will be entered into the eCRF using the electronic online database RedCap. Data to be collected are derived from the protocol.
The CRF and instructions for completing it will be provided by the Clinical Trial Centre/Västra Götaland, Sweden.
Handling and Storage of Data and Documents
- Data will be recorded in the eCRF (RedCap).
- Source data will be extracted from medical records.
- Records will be retained for at least 10 years after study completion.
- Conditions
- Surgical Complications
- Being tested
- Low calorie meal replacement plan
- Keywords
- liver surgery, low calorie diet
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Low calorie meal replacement planDietary supplement
Short-term LCD one week prio to liver surgery for patients with a BMI 30 or higher
| Study group | Role | What they receive |
|---|---|---|
| Standard | No intervention | Liver surgery standard of care |
| Intervention | Experimental | LCD Receives: Dietary Supplement: Low calorie meal replacement plan |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: From 1 week before to 30 days after liver surgery
Bleeding
Total intraoperative bleeding measured in millilitres
Measured: During liver surgery
Secondary outcomes (4)
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.
Measured: During liver surgery
Length of hospital stay (LOS - from the day of surgery until discharge from the hospital)
To compare LOS measured in days between the groups
Measured: From the day before surgery until 90 days postoperatively
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.
Measured: From surgery until definitive pathological report is documented in the medical records, ie an average of 3-12 weeks
Health-related quality of life (QoL)
Health-related QoL measured by QLQ-C30
Measured: Preoperatively and 30 days postoperatively
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Sep 2026
- Study start1 Jun 2026
- Primary completion1 Dec 2028 (estimated)
- Study completion1 Jul 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Surgical ComplicationsStudies of the same condition, open and under way.
- More trials run by Region SkaneThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Region Skane
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07801716
- Sponsor's protocol ID
- Ethix dnr 2025-02719-01
- Other IDs
- SLS-1023200
- Acronym
- LowCaLi
- Status last verified
- Jun 2026
- First submitted
- 17 Nov 2025
- Last updated
- 3 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Low Calorie Diet Before Liver Surgery - A Nordic Multicentre Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT07801716
- Acronym / sponsor ID
- LowCaLi / Ethix dnr 2025-02719-01
- Conditions
- Surgical Complications
- Keywords
- liver surgery, low calorie diet
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Region SkaneUniversity, hospital or other
- Study start
- 1 Jun 2026 (actual)
- Primary completion
- 1 Dec 2028 (estimated)
- Study completion
- 1 Jul 2029 (estimated)
- First posted
- 3 Sep 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
The LowCaLi study is a multicentre, open-label, randomized controlled trial.
Hypothesis
- A 7-day preoperative LCD reduces postoperative complications.
- LCD reduces intraoperative bleeding and postoperative complication rate.
- LCD reduces liver volume, facilitates access, and shortens operating time.
- LCD decreases hepatic glycogen and steatosis.
- LCD improves coagulation.
- LCD modifies plasma lipid and fatty acid composition.
Primary Objective To investigate whether a 7-day preoperative LCD reduces postoperative complications as measured by the Comprehensive Complication Index (CCI).
Secondary Objectives
- To assess the effect of LCD on intraoperative blood loss and transfusion requirements.
- To evaluate parenchymal dissection time and total surgical duration.
- To measure hospital length of stay.
- To determine R0 resection rate (tumour-free margins).
- To analyse systemic inflammatory response.
- To evaluate compliance with the intervention.
- To assess health-related quality of life (QLQ-C30).
Sample Size Calculation Barth et al. (2019) demonstrated a reduction in bleeding from 300 ml to 200 ml with LCD, requiring 32 patients for 80% power at α=0.05. For CCI reduction (21→13, SD=20), 98 patients per arm are required. To account for attrition, 200 patients (100 per group) will be recruited.
Study Procedures
- Screening and randomization at preoperative visit
- LCD intervention: 7 days prior to surgery
- Follow-up phone calls during the intervention period
- Structured intraoperative assessment by surgeon
- Postoperative follow-up including complications, pathology, and length of stay
- Patient-reported outcomes collected preoperatively and at 30 days postoperatively
Workflow Eligible patients will be identified during the mandatory pre-surgery outpatient visit. Written and oral study information will be provided, and informed consent obtained. Patients will then be randomized (1:1) using a web-based module in the eCRF (RedCap).
Randomization will be stratified by surgical approach (open vs. minimally invasive). The intervention group will follow a 7-day LCD (1000 kcal/day), using a standardized commercial product such as for example Modifast). The control group will receive standard preoperative care, including carbohydrate preloading, without diet restriction.
Study nurses will provide dietary instructions and monitor compliance through scheduled phone calls. Following surgery, the operating surgeon will complete a structured form documenting liver mobility, parenchymal texture, and intraoperative blood loss. Patient-reported quality of life will be assessed preoperatively and 30 days postoperatively.
Withdrawal of Individual Subjects Participation is voluntary. Patients may withdraw at any time without consequences for clinical care.
Follow-up of Subjects Withdrawn from Treatment Data collected up to the time of withdrawal will be included if the patient consents.
Statistical Analysis Primary analysis: comparison of CCI between groups using t-test or Mann-Whitney U test. Secondary analyses: regression models for continuous outcomes, chi-square/Fisher's exact tests for categorical data, and Kaplan-Meier analysis for time-to-event outcomes. Both intention-to-treat and per-protocol analyses will be performed.
ETHICAL CONSIDERATIONS Regulation Statement: The study will be conducted in accordance with the Declaration of Helsinki, ICH-GCP, and national legislation. Recruitment and Consent: To avoid bias, brief study information will be given to all eligible patients before randomization. Full dietary details will only be disclosed to participants allocated to the intervention group. Written informed consent is required prior to enrolment. The intervention group will be recieve LCD för 7 days or be compensated for the extra cost due to LCD diet, in arrears.
Compensation for Injury Patients are covered by national patient insurance schemes. No monetary compensation will be provided to participants.
ADMINISTRATIVE ASPECTS, MONITORING AND PUBLICATION Handling and storage of data and documents The sponsor and the trial management team will oversee the conduct of the trial according to Good Clinical Practice (GCP). The local investigators will be responsible for conduct at their respective sites.
Data will be handled confidentially. Each patient will receive an anonymous identification code. To trace data, a subject identification code list will be used. Each participating site will keep the key to this code secure. The handling of data will comply with the EU General Data Protection Regulation (GDPR).
Data will be kept for a minimum of ten years according to current regulations. Data will be entered into the eCRF using the electronic online database RedCap. Data to be collected are derived from the protocol.
The CRF and instructions for completing it will be provided by the Clinical Trial Centre/Västra Götaland, Sweden.
Handling and Storage of Data and Documents
- Data will be recorded in the eCRF (RedCap).
- Source data will be extracted from medical records.
- Records will be retained for at least 10 years after study completion.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Standard | No intervention | –Liver surgery standard of care |
| Intervention | Experimental | Dietary Supplement: Low calorie meal replacement planLCD |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Scheduled for open or minimally invasive liver resection
- BMI ≥30
Key exclusion criteria (3 listed)
- Diagnosed liver cirrhosis
- Perihilar tumours
- Inability to understand written information in Swedish, Norwegian, Danish, or English
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Low calorie meal replacement planShort-term LCD one week prio to liver surgery for patients with a BMI 30 or higher | Dietary supplement | Intervention |
Primary outcome
Postoperative complications
Time frame: From 1 week before to 30 days after liver surgery
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
Time frame: During liver surgery
Total intraoperative bleeding measured in millilitres
4 secondary outcomes
Operating time
Time frame: During liver surgery
Length of hospital stay (LOS - from the day of surgery until discharge from the hospital)
Time frame: From the day before surgery until 90 days postoperatively
Radical resection (R0)
Time frame: From surgery until definitive pathological report is documented in the medical records, ie an average of 3-12 weeks
Health-related quality of life (QoL)
Time frame: Preoperatively and 30 days postoperatively
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Sep 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Helena Taflin, MD, PhD contact
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Low calorie meal replacement plan in people with Surgical Complications, run by Region Skane at 1 site in Sweden.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 3 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Sweden. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Jenny L Rystedt, MD, PhD (+46705124336, jenny.rystedt@med.lu.se), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Postoperative complications (time frame: From 1 week before to 30 days after liver surgery). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Sep 2026.