Cholecystitis/Cholelithiasis, Cholecystitis; Gallstone, Polyp Gallbladder
Conditions
Keywords
low pressure; laparoscopic cholecystectomy
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.
Interventions
OTHERLow Pressure Laparoscopic Cholecystectomy
Low Pressure Laparoscopic Cholecystectomy (10mmHg) is set as the experimental group.
OTHERStandard Pressure Laparoscopic Cholecystectomy
Standard Pressure Laparoscopic Cholecystectomy (14mmHg) is set as the control group.
Sponsors
Peking Union Medical College Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
DOUBLE (Subject, Outcomes Assessor)
Masking description
It will be single blinded. Operator, first assistant and data collector could not be blinded. Whereas patients, nurses, data analyzer, and those who have the access to the primary predictor will be blinded.
Eligibility
Sex/Gender
ALL
Age
18 Years to 85 Years
Healthy volunteers
No
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. -
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change of partial pressure of carbon dioxide（pCO2） | Within postoperative 30 days. | Change of pCO2 in arterial blood gas test |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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. |
| visual analogue scale (VAS) | During postoperative 24 hours. | For evaluation of postoperative pain degree, using VAS, scoring 1-10 scores. |
| complication rate | Within postoperative 30 days. | Rate of total postoperative complications |
Countries
China
Contacts
Primary ContactFeng Tian, Doctor
Backup ContactJun Lu, Doctor
Outcome results
None listed