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

Primary Purpose

Cholecystitis/Cholelithiasis, Cholecystitis; Gallstone, Polyp Gallbladder

Status
Unknown status
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
Low Pressure Laparoscopic Cholecystectomy
Standard Pressure Laparoscopic Cholecystectomy
Sponsored by
Peking Union Medical College Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Cholecystitis/Cholelithiasis focused on measuring low pressure; laparoscopic cholecystectomy

Eligibility Criteria

18 Years - 85 Years (Adult, Older Adult)All SexesDoes not accept 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. -

Sites / Locations

  • Peking Union Medical College HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Other

Arm Label

Low Pressure Laparoscopic Cholecystectomy

Standard Pressure Laparoscopic Cholecystectomy

Arm Description

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

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.

Outcomes

Primary Outcome Measures

Change of partial pressure of carbon dioxide（pCO2）
Change of pCO2 in arterial blood gas test

Secondary Outcome Measures

operation time
skin to skin operative duration
conversion rate to open surgery
Need of conversion to open surgery duo to adhesion, hemorrhage, or other reasons.
visual analogue scale (VAS)
For evaluation of postoperative pain degree, using VAS, scoring 1-10 scores.
complication rate
Rate of total postoperative complications

Full Information

First Posted
November 24, 2020
Last Updated
December 21, 2020
Sponsor
Peking Union Medical College Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT04670952
Brief Title
Potential Pulmonary Benefit of Low Pressure Laparoscopic Cholecystectomy in Selected Patients
Acronym
POPLOP
Official Title
The Pulmonary Effects of Low Pressure Versus Standard Pressure Laparoscopic Cholecystectomy in Patients With Cardiopulmonary Disorders: A Prospective Randomized Controlled Trial
Study Type
Interventional

2. Study Status

Record Verification Date
December 2020
Overall Recruitment Status
Unknown status
Study Start Date
June 10, 2019 (Actual)
Primary Completion Date
November 2021 (Anticipated)
Study Completion Date
December 2021 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Peking Union Medical College Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cholecystitis/Cholelithiasis, Cholecystitis; Gallstone, Polyp Gallbladder
Keywords
low pressure; laparoscopic cholecystectomy

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes 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.
Allocation
Randomized
Enrollment
140 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Low Pressure Laparoscopic Cholecystectomy
Arm Type
Experimental
Arm Description
LPLC refers to "Low Pressure Laparoscopic Cholecystectomy". In this arm, the pneumoperitoneum pressure is set as 10mmHg.
Arm Title
Standard Pressure Laparoscopic Cholecystectomy
Arm Type
Other
Arm 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.
Intervention Type
Other
Intervention Name(s)
Low Pressure Laparoscopic Cholecystectomy
Intervention Description
Low Pressure Laparoscopic Cholecystectomy (10mmHg) is set as the experimental group.
Intervention Type
Other
Intervention Name(s)
Standard Pressure Laparoscopic Cholecystectomy
Intervention Description
Standard Pressure Laparoscopic Cholecystectomy (14mmHg) is set as the control group.
Primary Outcome Measure Information:
Title
Change of partial pressure of carbon dioxide（pCO2）
Description
Change of pCO2 in arterial blood gas test
Time Frame
Within postoperative 30 days.
Secondary Outcome Measure Information:
Title
operation time
Description
skin to skin operative duration
Time Frame
During surgery.
Title
conversion rate to open surgery
Description
Need of conversion to open surgery duo to adhesion, hemorrhage, or other reasons.
Time Frame
During surgery.
Title
visual analogue scale (VAS)
Description
For evaluation of postoperative pain degree, using VAS, scoring 1-10 scores.
Time Frame
During postoperative 24 hours.
Title
complication rate
Description
Rate of total postoperative complications
Time Frame
Within postoperative 30 days.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Aged 18-85; Patients receiving laparoscopic cholecystectomy due to benign gallbladder diseases; 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); Aged older than 60, with or without the above diseases; American society of Aneshesiologists (ASA) II or higher; Informed consent acquired. Exclusion Criteria: Having contraindication of laparoscopic operations; History at epigastric surgery. -
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Feng Tian, Doctor
Phone
+86-01069152600
Email
andytianfeng@126.com
First Name & Middle Initial & Last Name or Official Title & Degree
Jun Lu, Doctor
Phone
+86-01069152601
Email
pumchtf@sina.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Xiaodong He, Doctor
Organizational Affiliation
Peking Union Medical College Hospital
Official's Role
Study Director
Facility Information:
Facility Name
Peking Union Medical College Hospital
City
Beijing
State/Province
Beijing
ZIP/Postal Code
100730
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Hui Xu, Docor
Phone
+86-01069156874
Email
pumchkyc@126.com
First Name & Middle Initial & Last Name & Degree
Feng Tian, Doctor

12. IPD Sharing Statement

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Potential Pulmonary Benefit of Low Pressure Laparoscopic Cholecystectomy in Selected Patients

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