Potential Pulmonary Benefit of Low Pressure Laparoscopic Cholecystectomy in Selected Patients

Not Applicable

• Conditions: Cholecystitis/Cholelithiasis; Polyp Gallbladder; Cholecystitis; Gallstone
• Interventions: Other: Standard Pressure Laparoscopic Cholecystectomy; Other: Low Pressure Laparoscopic Cholecystectomy

• Registration Number: NCT04670952
• Lead Sponsor: Peking Union Medical College Hospital

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.

Study Timeline

• Study Start: 2019-06-10
• Study First Submitted: 2020-11-24
• Status Verified: 2020-12
• Study First Submitted QC: 2020-12-14
• Study First Posted: 2020-12-17
• Last Update Submitted: 2020-12-21
• Last Update Posted: 2020-12-23
• Primary Completion: 2021-11
• Study Completion: 2021-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 140

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. -

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Standard Pressure Laparoscopic Cholecystectomy	Standard Pressure Laparoscopic Cholecystectomy	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.
Low Pressure Laparoscopic Cholecystectomy	Low Pressure Laparoscopic Cholecystectomy	LPLC refers to "Low Pressure Laparoscopic Cholecystectomy". In this arm, the pneumoperitoneum pressure is set as 10mmHg.

Primary Outcome Measures

Name	Time	Method
Change of partial pressure of carbon dioxide（pCO2）	Within postoperative 30 days.	Change of pCO2 in arterial blood gas test

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Peking Union Medical College Hospital; 🇨🇳 Beijing, Beijing, China