Intraoperative Blood Loss Under Standard Versus Low Pneumoperitoneum Pressure During Laparoscopic Liver Resection.
Primary Purpose
Liver Tumor
Status
Recruiting
Phase
Not Applicable
Locations
Poland
Study Type
Interventional
Intervention
Pneumoperitoneum 14mmHg
Pneumoperitoneum 10mmHg
Sponsored by
About this trial
This is an interventional treatment trial for Liver Tumor focused on measuring laparoscopic liver resection, pneumoperitoneum pressure, blood loss
Eligibility Criteria
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 Emergency surgery Pregnancy Patient's refusal of participation
Sites / Locations
- Department of General, Transplant and Liver Surgery, Medical University of WarsawRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Experimental
Arm Label
Standard pneumoperitoneum pressure
Low pneumoperitoneum pressure
Arm Description
Laparoscopic liver resection performed in standard (14mmHg) pneumoperitoneum pressure
Laparoscopic liver resection performed in low (10mmHg) pneumoperitoneum pressure
Outcomes
Primary Outcome Measures
Intraoperative blood loss
Intraoperative blood loss in ml
Secondary Outcome Measures
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 adverse events
Expressed in accordance to ClassIntra scale
Grades 0-V (where 0 means no deviation; V- intraoperative death of the patient)
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)
Risk of postoperative complications
Expressed in accordance to Clavien-Dindo classification in 30-day postoperative period
Length of hospital stay
Expressed in days
Full Information
NCT ID
NCT06060899
First Posted
August 26, 2023
Last Updated
September 23, 2023
Sponsor
Medical University of Warsaw
Collaborators
Jagiellonian University, Regional Oncology Center, Białystok, Poland
1. Study Identification
Unique Protocol Identification Number
NCT06060899
Brief Title
Intraoperative Blood Loss Under Standard Versus Low Pneumoperitoneum Pressure During Laparoscopic Liver Resection.
Official Title
Intraoperative Blood Loss Under Standard Versus Low Pneumoperitoneum Pressure During Laparoscopic Liver Resection: Study Protocol for a Randomized Controlled Trial
Study Type
Interventional
2. Study Status
Record Verification Date
September 2023
Overall Recruitment Status
Recruiting
Study Start Date
January 1, 2023 (Actual)
Primary Completion Date
December 31, 2023 (Anticipated)
Study Completion Date
January 31, 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Medical University of Warsaw
Collaborators
Jagiellonian University, Regional Oncology Center, Białystok, Poland
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
Brief Summary
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) versus low (10 mmHg) 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.
Detailed Description
After signing the informed consent patients will be randomized into 2 groups.This stratification is aimed to reduce a strong risk factor for intraoperative blood loss which is the difficulty of performed procedure. Applied classification is simple to use and contains blood loos as one of the three main classifiers to determine the difficulty (beside operative time and conversion rate). Stratified 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:
low central vein pressure, aimed for 5 ± 2 mmHg with restrictive fluid therapy
ventilation in a volume-controlled mode without intraoperative high positive end-expiratory pressure (PEEP)
invasive arterial blood pressure monitoring with maintaining mean arterial pressure ≥ 60 mmHg
maintaining hemoglobin concentration > 8g/dl
maintaining normothermia and normoglycemia
maintaining oxygenation >94%, in case of hypercapnia with respiratory acidosis, the respiratory rate and tidal volume will be stepwise increased
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.
During the procedure, the surgeon will be asked for rating the quality of operating space in accordance to the Leiden Surgical Rating Scale every 60 minutes. 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Liver Tumor
Keywords
laparoscopic liver resection, pneumoperitoneum pressure, blood loss
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
36 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Standard pneumoperitoneum pressure
Arm Type
Active Comparator
Arm Description
Laparoscopic liver resection performed in standard (14mmHg) pneumoperitoneum pressure
Arm Title
Low pneumoperitoneum pressure
Arm Type
Experimental
Arm Description
Laparoscopic liver resection performed in low (10mmHg) pneumoperitoneum pressure
Intervention Type
Procedure
Intervention Name(s)
Pneumoperitoneum 14mmHg
Intervention Description
Performing surgery in 14mmHg pneumoperitoneum pressure
Intervention Type
Procedure
Intervention Name(s)
Pneumoperitoneum 10mmHg
Intervention Description
Performing surgery in 10mmHg pneumoperitoneum pressure
Primary Outcome Measure Information:
Title
Intraoperative blood loss
Description
Intraoperative blood loss in ml
Time Frame
Intraoperative
Secondary Outcome Measure Information:
Title
Quality of the operating space
Description
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
Title
Intraoperative adverse events
Description
Expressed in accordance to ClassIntra scale
Grades 0-V (where 0 means no deviation; V- intraoperative death of the patient)
Time Frame
Intraoperative
Title
Quality of postoperative rehabilitation
Description
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
Title
Risk of postoperative complications
Description
Expressed in accordance to Clavien-Dindo classification in 30-day postoperative period
Time Frame
30 postoperative days
Title
Length of hospital stay
Description
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
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Emergency surgery
Pregnancy
Patient's refusal of participation
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Wacław Hołówko, MD, PhD
Phone
+48667667044
Email
waclaw.holowko@wum.edu.pl
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Wacław Hołówko, MD, PhD
Organizational Affiliation
Medical University of Warsaw
Official's Role
Principal Investigator
Facility Information:
Facility Name
Department of General, Transplant and Liver Surgery, Medical University of Warsaw
City
Warsaw
Country
Poland
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Wacław Hołówko
Phone
0048667667044
Email
waclaw.holowko@wum.edu.pl
12. IPD Sharing Statement
Plan to Share IPD
Yes
IPD Sharing Plan Description
Protocol will be published in a journal
IPD Sharing Time Frame
31/12/2023
IPD Sharing Access Criteria
Open access
Learn more about this trial
Intraoperative Blood Loss Under Standard Versus Low Pneumoperitoneum Pressure During Laparoscopic Liver Resection.
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