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NCT06060899Completed

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

Source: ClinicalTrials.gov · Last updated 19 Sept 2024

Brief summary (registry, in English)

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 (registry)
Completed
Study type
Interventional
Enrollment
36 (actual)
First submitted
26 Aug 2023
Start date
1 Jan 2023
Primary completion date
30 Jul 2024
Lead sponsor
Medical University of Warsaw
NCT number
NCT06060899

What you commit to

  • Study type: Interventional
  • Participants enrolled: 36
  • From 1 Jan 2023 to the primary completion date, 30 Jul 2024
  • 1 site in 1 country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Prior treatment

  • Emergency surgery

Other illness

  • Severe cardiopulmonary disease
  • Severe renal disease

Other

  • Liver cirrhosis
  • Pregnancy
  • Patient's refusal of participation

Who the study is looking for

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

Age in the registry: 18 years to 80 years · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (1)

Sites in registry order. Save your city in your profile to sort them by distance.

SiteCityCountrySite status
Department of General, Transplant and Liver Surgery, Medical University of Warsaw
Coordinator of this site? Confirm its status
WarsawPolandUnknown status

This page is information, not medical advice. Discuss any trial with your doctor.