Liver Tumor Clinical Trial
Official title:
Intraoperative Blood Loss Under Standard Versus Low Pneumoperitoneum Pressure During Laparoscopic Liver Resection: Study Protocol for a Randomized Controlled Trial
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.
Status | Recruiting |
Enrollment | 36 |
Est. completion date | July 31, 2024 |
Est. primary completion date | June 30, 2024 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 80 Years |
Eligibility | Inclusion Criteria: - Patients scheduled to perform elective laparoscopic major liver resection - Age of 18 years or older - Body mass index (BMI) between 18.5 kg/m2 and 35 kg/m2 - Signed informed consent Exclusion Criteria: - Severe cardiopulmonary disease - Severe renal disease - Liver cirrhosis - Emergency surgery - Pregnancy - Patient's refusal of participation |
Country | Name | City | State |
---|---|---|---|
Poland | Department of General, Transplant and Liver Surgery, Medical University of Warsaw | Warsaw |
Lead Sponsor | Collaborator |
---|---|
Medical University of Warsaw | Jagiellonian University, Regional Oncology Center, Bialystok, Poland |
Poland,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Intraoperative blood loss | Intraoperative blood loss in ml | Intraoperative | |
Secondary | 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. |
Intraoperative | |
Secondary | Intraoperative adverse events | Expressed in accordance to ClassIntra scale
Grades 0-V (where 0 means no deviation; V- intraoperative death of the patient) |
Intraoperative | |
Secondary | 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) |
Postoperative day 1, Postoperative day 3, Postoperative day 5 | |
Secondary | Risk of postoperative complications | Expressed in accordance to Clavien-Dindo classification in 30-day postoperative period | 30 postoperative days | |
Secondary | Length of hospital stay | Expressed in days | From date of surgery until the date of disscharge or date of death from any cause, whichever came first, assessed up to 100 days |
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