Potential Pulmonary Benefit of Low Pressure Laparoscopic Cholecystectomy in Selected Patients

Cholecystitis; Gallstone Clinical Trial

— POPLOP  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04670952
• Other study ID #: Feng Tian
• Status: Recruiting
• Phase: N/A
• Start date: June 10, 2019
• Est. completion date: December 2021

Study information

• Verified date: December 2020
• Source: Peking Union Medical College Hospital
• Contact: Feng Tian, Doctor
• Phone: +86-01069152600
• Email: andytianfeng[@]126.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 140
• Est. completion date: December 2021
• Est. primary completion date: November 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 85 Years

Eligibility

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. -

Related Conditions & MeSH terms

• Cholecystitis
• Cholecystitis/Cholelithiasis
• Cholecystitis; Gallstone
• Cholecystolithiasis
• Cholelithiasis
• Gallstones
• Polyp Gallbladder

Intervention

Other:
• Low Pressure Laparoscopic Cholecystectomy
Low Pressure Laparoscopic Cholecystectomy (10mmHg) is set as the experimental group.
• Standard Pressure Laparoscopic Cholecystectomy
Standard Pressure Laparoscopic Cholecystectomy (14mmHg) is set as the control group.

Locations

Country	Name	City	State
China	Peking Union Medical College Hospital	Beijing	Beijing

Sponsors (1)

Lead Sponsor	Collaborator
Peking Union Medical College Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change of partial pressure of carbon dioxide(pCO2)	Change of pCO2 in arterial blood gas test	Within postoperative 30 days.
Secondary	operation time	skin to skin operative duration	During surgery.
Secondary	conversion rate to open surgery	Need of conversion to open surgery duo to adhesion, hemorrhage, or other reasons.	During surgery.
Secondary	visual analogue scale (VAS)	For evaluation of postoperative pain degree, using VAS, scoring 1-10 scores.	During postoperative 24 hours.
Secondary	complication rate	Rate of total postoperative complications	Within postoperative 30 days.