Clinical trial · Interventional
Intraoperative Blood Loss Under Standard Versus Low Pneumoperitoneum Pressure During Laparoscopic Liver Resection.
Intraoperative Blood Loss Under Standard Versus Low Pneumoperitoneum Pressure During Laparoscopic Liver Resection: Study Protocol for a Randomized Controlled Trial
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
Commonly the pressure of about 14 mmHg is applied during laparoscopic liver resection (LLR) with moderate neuromuscular blockade. Lowering the pneumoperitoneum pressure combined with deep neuromuscular blockade may sustain optimal operating space with providing better short-term postoperative results. It has been proved in randomized controlled trials in colorectal or bariatric patients, however there is lack of similar data for laparoscopic liver resection. Doubts about lowering the pneumoperitoneum pressure too hasty are supported by apprehension of worse bleeding control during liver parenchyma transection and its impact on postoperative results. The aim of the trial is to assess the impact of standard (14 mmHg; arm 1) versus low (10 mmHg; arm 2) pneumoperitoneum pressure on intraoperative blood loss, what will be the primary outcome. As secondary endpoints following outcomes will be measured: quality of operating space, intraoperative adverse events, quality of recovery, postoperative renal function, 30-day postoperative complications rate, length of hospital stay. The investigators assume that lower pneumoperitoneum provides non-inferior blood loss control during laparoscopic liver resection with better postoperative results.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Liver Tumor | Liver Neoplasm | ALIAS | 0.90 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Pneumoperitoneum 10mmHg | Procedure | — | UNRESOLVED |
| Pneumoperitoneum 14mmHg | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- ACTIVE_COMPARATOR
- label
- Standard pneumoperitoneum pressure
- description
- Laparoscopic liver resection performed in standard (14mmHg) pneumoperitoneum pressure
- interventionNames
- Procedure: Pneumoperitoneum 14mmHg
- type
- EXPERIMENTAL
- label
- Low pneumoperitoneum pressure
- description
- Laparoscopic liver resection performed in low (10mmHg) pneumoperitoneum pressure
- interventionNames
- Procedure: Pneumoperitoneum 10mmHg
Primary outcomes (1)
- measure
- Intraoperative blood loss
- timeFrame
- Intraoperative
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 80 Years
Show eligibility criteria text
Inclusion Criteria: * Patients scheduled to perform elective laparoscopic major liver resection * Age of 18 years or older * Signed informed consent Exclusion Criteria: * Severe cardiopulmonary disease * Severe renal disease * Liver cirrhosis * Emergency surgery * Pregnancy * Patient's refusal of participation
References
Publications (0)
Data not yet available