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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.
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, LPLCï¼›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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Low Pressure Laparoscopic Cholecystectomy | Experimental | LPLC refers to "Low Pressure Laparoscopic Cholecystectomy". In this arm, the pneumoperitoneum pressure is set as 10mmHg. |
|
| Standard Pressure Laparoscopic Cholecystectomy | Other | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Low Pressure Laparoscopic Cholecystectomy | Other | Low Pressure Laparoscopic Cholecystectomy (10mmHg) is set as the experimental group. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change of partial pressure of carbon dioxide(pCO2) | Change of pCO2 in arterial blood gas test | Within postoperative 30 days. |
| 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Feng Tian, Doctor | Contact | +86-01069152600 | andytianfeng@126.com | |
| Jun Lu, Doctor | Contact | +86-01069152601 | pumchtf@sina.com |
| Name | Affiliation | Role |
|---|---|---|
| Xiaodong He, Doctor | Peking Union Medical College Hospital | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Peking Union Medical College Hospital | Recruiting | Beijing | Beijing Municipality | 100730 | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 39506748 | Derived | 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. |
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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.
| Standard Pressure Laparoscopic Cholecystectomy | Other | Standard Pressure Laparoscopic Cholecystectomy (14mmHg) is set as the control group. |
|
| 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. |
| ID | Term |
|---|---|
| D002764 | Cholecystitis |
| D002769 | Cholelithiasis |
| D042882 | Gallstones |
| ID | Term |
|---|---|
| D005705 | Gallbladder Diseases |
| D001660 | Biliary Tract Diseases |
| D004066 | Digestive System Diseases |
| D041761 | Cholecystolithiasis |
| D002137 | Calculi |
| D020763 | Pathological Conditions, Anatomical |
| D013568 | Pathological Conditions, Signs and Symptoms |
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