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

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.

Study Overview

• Status: Recruiting
• Conditions: Liver Tumor
• Intervention / Treatment: Procedure: Pneumoperitoneum 14mmHg; Procedure: Pneumoperitoneum 10mmHg

Detailed Description

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:

• 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. 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.

• Study Type: Interventional
• Enrollment (Estimated): 36
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Wacław Hołówko, MD, PhD; Phone Number: +48667667044; Email: waclaw.holowko@wum.edu.pl

Study Locations

• Poland
  • Warsaw, Poland
    • Recruiting
    • Department of General, Transplant and Liver Surgery, Medical University of Warsaw
    • Contact: Wacław Hołówko; Phone Number: 0048667667044; Email: waclaw.holowko@wum.edu.pl

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Standard pneumoperitoneum pressure; Laparoscopic liver resection performed in standard (14mmHg) pneumoperitoneum pressure	Procedure: Pneumoperitoneum 14mmHg; Performing surgery in 14mmHg pneumoperitoneum pressure
Experimental: Low pneumoperitoneum pressure; Laparoscopic liver resection performed in low (10mmHg) pneumoperitoneum pressure	Procedure: Pneumoperitoneum 10mmHg; Performing surgery in 10mmHg pneumoperitoneum pressure

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Intraoperative blood loss	Intraoperative blood loss in ml	Intraoperative

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
Intraoperative adverse events	Expressed in accordance to ClassIntra scale Grades 0-V (where 0 means no deviation; V- intraoperative death of the patient)	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)	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	30 postoperative days
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

Collaborators and Investigators

• Sponsor: Medical University of Warsaw
• Collaborators: Jagiellonian University; Regional Oncology Center, Białystok, Poland
• Investigators: Principal Investigator: Wacław Hołówko, MD, PhD, Medical University of Warsaw

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2023
• Primary Completion (Estimated): June 30, 2024
• Study Completion (Estimated): July 31, 2024

Study Registration Dates

• First Submitted: August 26, 2023
• First Submitted That Met QC Criteria: September 23, 2023
• First Posted (Actual): September 29, 2023

Study Record Updates

• Last Update Posted (Estimated): February 21, 2024
• Last Update Submitted That Met QC Criteria: February 19, 2024
• Last Verified: February 1, 2024

More Information

Terms related to this study

• Keywords: blood loss; pneumoperitoneum pressure; laparoscopic liver resection
• Additional Relevant MeSH Terms: Digestive System Diseases; Pathologic Processes; Peritoneal Diseases; Pneumoperitoneum; Hemorrhage
• Other Study ID Numbers: KB/160/2022

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: Protocol will be published in a journal
• IPD Sharing Time Frame: 31/12/2023
• IPD Sharing Access Criteria: Open access
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No