NCT04670952

Potential Pulmonary Benefit of Low Pressure Laparoscopic Cholecystectomy in Selected Patients

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

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 140 (estimated)
• Sponsor: Peking Union Medical College Hospital · Academic / Other
• Sex: All
• Age: 18 Years – 85 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Cholecystitis/Cholelithiasis
• Cholecystitis; Gallstone
• Polyp Gallbladder

Interventions

Type	Name	Description
OTHER	Low Pressure Laparoscopic Cholecystectomy	Low Pressure Laparoscopic Cholecystectomy (10mmHg) is set as the experimental group.
OTHER	Standard Pressure Laparoscopic Cholecystectomy	Standard Pressure Laparoscopic Cholecystectomy (14mmHg) is set as the control group.

Timeline

• Start date: 2019-06-10
• Primary completion: 2021-11-01
• Completion: 2021-12-01
• First posted: 2020-12-17
• Last updated: 2020-12-23

Locations

1 site across 1 country: China