An interventional study of Pneumoperitoneum 14mmHg and Pneumoperitoneum 10mmHg in Liver Tumor, sponsored by Medical University of Warsaw. Completed at 1 site in Poland. Open to participants aged 18 Years to 80 Years. Per ClinicalTrials.gov, last updated 2024-09-19.
Sponsored by Medical University of Warsaw · Not applicable, Interventional, and Treatment
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.
After signing the informed consent patients will be randomized into 2 groups. Randomization will be conducted by investigators via drawing a sealed envelope with computer-generated intervention code at the Department just before patient transfer to the operating theatre. There will be two study arms with 1:1 fashion
For both trial arms additional routine elements of perioperative anesthesia care will be defined:
The surgeon will be blinded to the study arm and level of pneumoperitoneum pressure.
The blood loss during liver parenchyma transection and total procedure blood loss will be reported based on the amount of sucked outside intraperitoneal fluids after liver transection and after procedure without volume inserted for intraperitoneal irrigation. The estimated blood loss will be measured in milliliters. Patients who are converted to open surgery are excluded from the analysis of the primary end-point.
During the procedure, the surgeon will be asked regularly to rate the quality of operating space in accordance to the Leiden Surgical Rating Scale. In case of inadequate operating space, pneumoperitoneum pressure may be increased by 2 mmHg (with maximum of 16 mmHg in arm 1. and 12 mmHg in arm 2.). Intraoperative adverse events will be assessed in accordance to ClassIntra classification. Quality of recovery (QoR) will be measured on postoperative day 1, 3 and 5 with patient reported QoR-40 questionnaire, 30-day postoperative complication rate will be assessed in accordance to Clavien-Dindo classification. Length of hospital stay will be counted from the date of surgery to the discharge day. All patients will be followed up by researchers who are blinded to the intraoperative grouping.
149 studies on the registry are indexed under Pneumoperitoneum; 29 are open to participants now.
This study's enrollment of 36 is below the median of 79 across 96 interventional studies indexed under Pneumoperitoneum.
Browse Pneumoperitoneum studies →Medical University of Warsaw is the lead sponsor of 316 studies on the registry; 87 are open to participants now.
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Exclusion Criteria:
Laparoscopic liver resection performed in standard (14mmHg) pneumoperitoneum pressure
Procedure: Pneumoperitoneum 14mmHg
Laparoscopic liver resection performed in low (10mmHg) pneumoperitoneum pressure
Procedure: Pneumoperitoneum 10mmHg
Performing surgery in 14mmHg pneumoperitoneum pressure
Performing surgery in 10mmHg pneumoperitoneum pressure
Intraoperative blood loss
Intraoperative blood loss in ml
Time frame: Intraoperative
Quality of the operating space
Expressed in accordance to Leiden scale (L-SRS) and the rate of need for increase of pneumoperitoneum pressure Score 1-5 (where 1 means extremely poor conditions; 5- optimal conditions) From multiple measurements, value submitted for analysis will be the lowest reported during the surgery.
Time frame: Intraoperative
Intraoperative adverse events
Expressed in accordance to ClassIntra scale Grades 0-V (where 0 means no deviation; V- intraoperative death of the patient)
Time frame: Intraoperative
Quality of postoperative rehabilitation
Expressed in accordance to questionaire QoR-40 40 questions with 1-5 points each (total score minimum 40 points; maximum 200 points)
Time frame: Postoperative day 1, Postoperative day 3, Postoperative day 5
Risk of postoperative complications
Expressed in accordance to Clavien-Dindo classification in 30-day postoperative period
Time frame: 30 postoperative days
Length of hospital stay
Expressed in days
Time frame: From date of surgery until the date of disscharge or date of death from any cause, whichever came first, assessed up to 100 days
Plan to share: Yes — Protocol will be published in a journal
Supporting information: Study protocol
No publications or documents are linked to this record.
This study is completed, as verified in Sep 2024. You cannot join it, but the record below documents what was studied.
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Medical University of Warsaw