Clinical trial NCT04670952: Potential Pulmonary Benefit of Low Pressure Laparoscopic Cholecystectomy in Selected Patients
Official title: The Pulmonary Effects of Low Pressure Versus Standard Pressure Laparoscopic Cholecystectomy in Patients With Cardiopulmonary Disorders: A Prospective Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Cholecystitis/Cholelithiasis
Cholecystitis; Gallstone
Polyp Gallbladder
Keywords: low pressure; laparoscopic cholecystectomy
Lead sponsor: Peking Union Medical College Hospital
Sponsor class: OTHER
First posted: 2020-12-17
Enrollment: 140
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: Standard Pressure Laparoscopic Cholecystectomy，as the standard for cholecystectomy, can lead to about 15% of pulmonary atelectasis. According to literature, low pressure laparoscopic cholecystectomy is thought to probably decrease cardio-pulmonary related complications and postoperative pain. However, the previous studies have presented controversial results. Our study aim to evaluate the potential pulmonary benefit of low pressure laparoscopic cholecystectomy in elderly or patients accompanied with cardio-pulmonary disorders.

Detailed description: Standard Pressure Laparoscopic Cholecystectomy, SPLC；12-16mmHg，as the standard for cholecystectomy, can lead to about 15% of pulmonary atelectasis.

According to literature, Low Pressure Laparoscopic Cholecystectomy, LPLC；8-10mmHg is thought to probably decrease cardio-pulmonary related complications and postoperative pain. However, most of the existing study have combined population with all age scale, bringing bias to the result. Our study aim to evaluate the potential pulmonary benefit of low pressure laparoscopic cholecystectomy in elderly or patients accompanied with cardio-pulmonary disorders.

Eligibility criteria: Inclusion Criteria:

1. Aged 18-85;
2. Patients receiving laparoscopic cholecystectomy due to benign gallbladder diseases;
3. Older patient or accompanied by cardiopulmonary diseases (age\>60 years, hypertension, Diabetes Mellitus, coronary heart disease, arrhythmia, chronic bronchitis, emphysema, history of heart surgery, history of lung surgery, history of mediastinal surgery, asthma, et al);
4. Aged older than 60, with or without the above diseases;
5. American society of Aneshesiologists (ASA) II or higher;
6. Informed consent acquired.

Exclusion Criteria:

1. Having contraindication of laparoscopic operations;
2. History at epigastric surgery. -

Primary outcomes:
measure: Change of partial pressure of carbon dioxide（pCO2）
timeFrame: Within postoperative 30 days.
Secondary outcomes:
measure: operation time
timeFrame: During surgery.
measure: conversion rate to open surgery
timeFrame: During surgery.
measure: visual analogue scale (VAS)
timeFrame: During postoperative 24 hours.
measure: complication rate
timeFrame: Within postoperative 30 days.
Other outcomes:
Locations:
city: Beijing
country: China
facility: Peking Union Medical College Hospital
state: Beijing
Study officials:
affiliation: Peking Union Medical College Hospital
name: Xiaodong He, Doctor
role: STUDY_DIRECTOR
References: