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

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

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.

Study Overview

• Status: Unknown
• Conditions: Cholecystitis; Gallstone; Cholecystitis/Cholelithiasis; Polyp Gallbladder
• Intervention / Treatment: Other: Low Pressure Laparoscopic Cholecystectomy; Other: Standard Pressure Laparoscopic Cholecystectomy

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 Type: Interventional
• Enrollment (Anticipated): 140
• Phase: Not Applicable

Contacts and Locations

Study Locations

• China
  • Beijing
    • Beijing, Beijing, China, 100730
      • Recruiting
      • Peking Union Medical College Hospital
      • Contact: Hui Xu, Docor; Phone Number: +86-01069156874; Email: pumchkyc@126.com
      • Principal Investigator: Feng Tian, Doctor

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 85 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Low Pressure Laparoscopic Cholecystectomy; LPLC refers to "Low Pressure Laparoscopic Cholecystectomy". In this arm, the pneumoperitoneum pressure is set as 10mmHg.	Other: Low Pressure Laparoscopic Cholecystectomy; Low Pressure Laparoscopic Cholecystectomy (10mmHg) is set as the experimental group.
Other: 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.	Other: Standard Pressure Laparoscopic Cholecystectomy; Standard Pressure Laparoscopic Cholecystectomy (14mmHg) is set as the control group.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change of partial pressure of carbon dioxide（pCO2）	Change of pCO2 in arterial blood gas test	Within postoperative 30 days.

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Peking Union Medical College Hospital
• Investigators: Study Director: Xiaodong He, Doctor, Peking Union Medical College Hospital

Study record dates

Study Major Dates

• Study Start (Actual): June 10, 2019
• Primary Completion (Anticipated): November 1, 2021
• Study Completion (Anticipated): December 1, 2021

Study Registration Dates

• First Submitted: November 24, 2020
• First Submitted That Met QC Criteria: December 14, 2020
• First Posted (Actual): December 17, 2020

Study Record Updates

• Last Update Posted (Actual): December 23, 2020
• Last Update Submitted That Met QC Criteria: December 21, 2020
• Last Verified: December 1, 2020

More Information

Terms related to this study

• Keywords: low pressure; laparoscopic cholecystectomy
• Additional Relevant MeSH Terms: Digestive System Diseases; Pathological Conditions, Anatomical; Gallbladder Diseases; Biliary Tract Diseases; Calculi; Cholecystitis; Acalculous Cholecystitis; Gallstones; Cholelithiasis; Cholecystolithiasis
• Other Study ID Numbers: Feng Tian

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No