Potential Pulmonary Benefit of Low Pressure Laparoscopic Cholecystectomy in Selected Patients (POPLOP)

Chinese Academy of Medical Sciences & Peking Union Medical College

Status: Unknown

Conditions: Cholecystitis; Gallstone; Cholecystitis/Cholelithiasis; Polyp Gallbladder

Treatments: Other: Low Pressure Laparoscopic Cholecystectomy; Other: Standard Pressure Laparoscopic Cholecystectomy

Study type: Interventional

Funder types: Other

Identifiers

NCT04670952

Feng Tian

Details and patient eligibility

About

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.

Full 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.

Enrollment: 140 estimated patients

Sex: All

Ages: 18 to 85 years old

Volunteers: No Healthy Volunteers

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. -

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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140 participants in 2 patient groups

Low Pressure Laparoscopic Cholecystectomy

Experimental group

Description:

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

Treatment:

Other: Low Pressure Laparoscopic Cholecystectomy

Standard Pressure Laparoscopic Cholecystectomy

Other group

Description:

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.

Treatment:

Other: Standard Pressure Laparoscopic Cholecystectomy