Potential Pulmonary Benefit of Low Pressure Laparoscopic Cholecystectomy in Selected Patients

Study Results

Results pending

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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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

140 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-06-10

Study Completion Date

2021-12-31

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Cholecystitis/Cholelithiasis Cholecystitis; Gallstone Polyp Gallbladder

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

DOUBLE

Participants Outcome Assessors

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.

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.

Group Type EXPERIMENTAL

Low Pressure Laparoscopic Cholecystectomy

Intervention Type OTHER

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.

Group Type OTHER

Standard Pressure Laparoscopic Cholecystectomy

Intervention Type OTHER

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.

Intervention Type OTHER

Standard Pressure Laparoscopic Cholecystectomy

Standard Pressure Laparoscopic Cholecystectomy (14mmHg) is set as the control group.

Intervention Type OTHER

Eligibility Criteria

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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.