Potential Pulmonary Benefit of Low Pressure Laparoscopic Cholecystectomy in Selected Patients
NCT ID: NCT04670952
Last Updated: 2020-12-23
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
NA
140 participants
INTERVENTIONAL
2019-06-10
2021-12-31
Brief Summary
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Detailed Description
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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.
Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
DOUBLE
Study Groups
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Low Pressure Laparoscopic Cholecystectomy
LPLC refers to "Low Pressure Laparoscopic Cholecystectomy". In this arm, the pneumoperitoneum pressure is set as 10mmHg.
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.
Standard Pressure Laparoscopic Cholecystectomy
Standard Pressure Laparoscopic Cholecystectomy (14mmHg) is set as the control group.
Interventions
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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.
Eligibility Criteria
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Inclusion Criteria
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
2. History at epigastric surgery. -
18 Years
85 Years
ALL
No
Sponsors
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Peking Union Medical College Hospital
OTHER
Responsible Party
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Feng Tian
Attending
Principal Investigators
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Xiaodong He, Doctor
Role: STUDY_DIRECTOR
Peking Union Medical College Hospital
Locations
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Peking Union Medical College Hospital
Beijing, Beijing Municipality, China
Countries
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Central Contacts
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Facility Contacts
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Hui Xu, Docor
Role: primary
References
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Tian F, Sun X, Yu Y, Zhang N, Hong T, Liang L, Yao B, Song L, Pei C, Wang Y, Lu W, Qu Q, Guo J, Zhang T, He X. Comparison of low-pressure and standard-pressure pneumoperitoneum laparoscopic cholecystectomy in patients with cardiopulmonary comorbidities: a double blinded randomized clinical trial. BMC Surg. 2024 Nov 6;24(1):348. doi: 10.1186/s12893-024-02606-w.
Other Identifiers
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Feng Tian
Identifier Type: -
Identifier Source: org_study_id