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

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ClinicalTrials.gov Identifier: NCT04670952
Recruitment Status : Recruiting
First Posted : December 17, 2020
Last Update Posted : December 23, 2020
Sponsor:
Information provided by (Responsible Party):
Feng Tian, Peking Union Medical College Hospital

Study Description
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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.

Condition or disease Intervention/treatment Phase
Cholecystitis/Cholelithiasis Cholecystitis; Gallstone Polyp Gallbladder Other: Low Pressure Laparoscopic Cholecystectomy Other: Standard Pressure Laparoscopic Cholecystectomy Not Applicable

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 Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 140 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, 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.
Primary Purpose: Prevention
Official Title: The Pulmonary Effects of Low Pressure Versus Standard Pressure Laparoscopic Cholecystectomy in Patients With Cardiopulmonary Disorders: A Prospective Randomized Controlled Trial
Actual Study Start Date : June 10, 2019
Estimated Primary Completion Date : November 2021
Estimated Study Completion Date : December 2021

Resource links provided by the National Library of Medicine


Arms and Interventions
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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.
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.


Outcome Measures
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Primary Outcome Measures :
  1. Change of partial pressure of carbon dioxide（pCO2） [ Time Frame: Within postoperative 30 days. ]
    Change of pCO2 in arterial blood gas test


Secondary Outcome Measures :
  1. operation time [ Time Frame: During surgery. ]
    skin to skin operative duration

  2. conversion rate to open surgery [ Time Frame: During surgery. ]
    Need of conversion to open surgery duo to adhesion, hemorrhage, or other reasons.

  3. visual analogue scale (VAS) [ Time Frame: During postoperative 24 hours. ]
    For evaluation of postoperative pain degree, using VAS, scoring 1-10 scores.

  4. complication rate [ Time Frame: Within postoperative 30 days. ]
    Rate of total postoperative complications


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 85 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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. -
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04670952


Contacts
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Contact: Feng Tian, Doctor +86-01069152600 andytianfeng@126.com
Contact: Jun Lu, Doctor +86-01069152601 pumchtf@sina.com

Locations
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China, Beijing
Peking Union Medical College Hospital Recruiting
Beijing, Beijing, China, 100730
Contact: Hui Xu, Docor    +86-01069156874    pumchkyc@126.com   
Principal Investigator: Feng Tian, Doctor         
Sponsors and Collaborators
Peking Union Medical College Hospital
Investigators
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Study Director: Xiaodong He, Doctor Peking Union Medical College Hospital
More Information
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Responsible Party: Feng Tian, Attending, Peking Union Medical College Hospital
ClinicalTrials.gov Identifier: NCT04670952    
Other Study ID Numbers: Feng Tian
First Posted: December 17, 2020    Key Record Dates
Last Update Posted: December 23, 2020
Last Verified: December 2020

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Feng Tian, Peking Union Medical College Hospital:
low pressure; laparoscopic cholecystectomy
Additional relevant MeSH terms:
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Cholecystitis
Acalculous Cholecystitis
Gallstones
Cholelithiasis
Cholecystolithiasis
 Gallbladder Diseases
Biliary Tract Diseases
Digestive System Diseases
Calculi
Pathological Conditions, Anatomical