Potential Pulmonary Benefit of Low Pressure Laparoscopic Cholecystectomy in Selected Patients

Study Overview
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Brief Summary
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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
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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.

Official Title
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The Pulmonary Effects of Low Pressure Versus Standard Pressure Laparoscopic Cholecystectomy in Patients With Cardiopulmonary Disorders: A Prospective Randomized Controlled Trial

Conditions
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Cholecystitis/Cholelithiasis, Cholecystitis; Gallstone, Polyp Gallbladder

Intervention / Treatment
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* Other: Low Pressure Laparoscopic Cholecystectomy
* Other: Standard Pressure Laparoscopic Cholecystectomy


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Aged 18-85; Patients receiving laparoscopic cholecystectomy due to benign gallbladder diseases; 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); Aged older than 60, with or without the above diseases; American society of Aneshesiologists (ASA) II or higher; Informed consent acquired. Exclusion Criteria: Having contraindication of laparoscopic operations; History at epigastric surgery. -

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 85 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Low Pressure Laparoscopic Cholecystectomy<br>LPLC refers to Low Pressure Laparoscopic Cholecystectomy. In this arm, the pneumoperitoneum pressure is set as 10mmHg. | Other: Low Pressure Laparoscopic Cholecystectomy<br>* Low Pressure Laparoscopic Cholecystectomy (10mmHg) is set as the experimental group.<br>|
| Other: Standard Pressure Laparoscopic Cholecystectomy<br>This is taken as the control group. SPLC refers to Standard Pressure Laparoscopic Cholecystectomy. In this arm, the pneumoperitoneum pressure is set as 14 mmHg. | Other: Standard Pressure Laparoscopic Cholecystectomy<br>* Standard Pressure Laparoscopic Cholecystectomy (14mmHg) is set as the control group.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change of partial pressure of carbon dioxide（pCO2） | Change of pCO2 in arterial blood gas test | Within postoperative 30 days. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| operation time | skin to skin operative duration | During surgery. | 
| conversion rate to open surgery | Need of conversion to open surgery duo to adhesion, hemorrhage, or other reasons. | During surgery. | 
| visual analogue scale (VAS) | For evaluation of postoperative pain degree, using VAS, scoring 1-10 scores. | During postoperative 24 hours. | 
| complication rate | Rate of total postoperative complications | Within postoperative 30 days. | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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low pressure; laparoscopic cholecystectomy