Intraoperative Blood Loss Under Standard Versus Low Pneumoperitoneum Pressure During Laparoscopic Liver Resection.

NCT06060899 | Completed

• 1 other identifier: KB/160/2022
• Study Type: interventional
• Target: 36
• Locations: 1 country
• Sites: 1

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; 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

Liver Tumor

Keywords

laparoscopic liver resection; pneumoperitoneum pressure; blood loss

Outcome Measures

Primary Outcomes (1)

• Intraoperative blood loss

  Intraoperative blood loss in ml

  Intraoperative

Secondary Outcomes (5)

• Quality of the operating space

  Intraoperative

• Intraoperative adverse events

  Intraoperative

• Quality of postoperative rehabilitation

  Postoperative day 1, Postoperative day 3, Postoperative day 5

• Risk of postoperative complications

  30 postoperative days

• Length of hospital stay

  From date of surgery until the date of disscharge or date of death from any cause, whichever came first, assessed up to 100 days

Study Arms (2)

Standard pneumoperitoneum pressure

ACTIVE COMPARATOR

Laparoscopic liver resection performed in standard (14mmHg) pneumoperitoneum pressure

Procedure: Pneumoperitoneum 14mmHg

Low pneumoperitoneum pressure

EXPERIMENTAL

Laparoscopic liver resection performed in low (10mmHg) pneumoperitoneum pressure

Procedure: Pneumoperitoneum 10mmHg

Interventions

Pneumoperitoneum 14mmHg PROCEDURE

Performing surgery in 14mmHg pneumoperitoneum pressure

Standard pneumoperitoneum pressure

Pneumoperitoneum 10mmHg PROCEDURE

Performing surgery in 10mmHg pneumoperitoneum pressure

Low pneumoperitoneum pressure

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients scheduled to perform elective laparoscopic major liver resection
• Age of 18 years or older
• Signed informed consent

You may not qualify if:

• Severe cardiopulmonary disease
• Severe renal disease
• Liver cirrhosis
• Emergency surgery
• Pregnancy
• Patient's refusal of participation

Sponsors & Collaborators

• Medical University of Warsaw: lead
• Jagiellonian University: collaborator
• Regional Oncology Center, Białystok, Poland: collaborator

Study Sites (1)

Department of General, Transplant and Liver Surgery, Medical University of Warsaw

Warsaw, Poland

Location

MeSH Terms

Conditions

Carcinoma, Hepatocellular; Hemorrhage

Condition Hierarchy (Ancestors)

Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Liver Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Digestive System Diseases; Liver Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Wacław Hołówko, MD, PhD

  Medical University of Warsaw

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: August 26, 2023
• First Posted: September 29, 2023
• Study Start: January 1, 2023
• Primary Completion: July 30, 2024
• Study Completion: July 30, 2024
• Last Updated: September 19, 2024

Record last verified: 2024-09

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL
• Time Frame: 31/12/2023
• Access Criteria: Open access

Locations

PL (1)