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| ID | Type | Description | Link |
|---|---|---|---|
| 2014-21 | Other Grant/Funding Number | Ethic committee of China-Japan Friendship Hospital |
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We have designed a new method which could be used in laparoscopic cholecy- stectomy.Account to this new method, the three incisions are all located on the lower abdominal, theoretically it could get more beautiful outlook and less stress response than traditional laparoscopic cholecystectomy(two of the three incisions located on upper abdomen) or single port laparoscopic cholecystectomy(one large incision located on umbilicus).
We plan to conduct a randomized controlled trial to compare those there methods of laparoscopic cholecystectomy, in order to find out if there will be some advantages of this new method,such as in lowering the stress response,reducing impact on respiration, relieving post-operation pain and improving appearance.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| LALC | Experimental | lower abdominal laparoscopic cholecystectomy |
|
| SLC | Experimental | single laparoscopic cholecystectomy |
|
| UALC | Placebo Comparator | upper abdominal laparoscopic cholecystectomy |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| laparoscopic cholecystectomy | Procedure |
|
|
| Measure | Description | Time Frame |
|---|---|---|
| Systematic inflammatory response caused by the surgical trauma | Blood IL-6,TNF-α,and CRP levels determined by ELISA at different time-points, | one day before the operation,8 hours after the operation,one day after the operation |
| Measure | Description | Time Frame |
|---|---|---|
| Cosmesis and body image score | 1 and 3 months after the operation | |
| pulmonary function | one day before the operation, one day after the operation | |
| Post-operation pain score (visual analog scale, VAS) |
| Measure | Description | Time Frame |
|---|---|---|
| perioperative indexes | operative duration,intra-operative blood loss, indication for additional trocar placement or conversion to open surgery, postoperative complications and duration of postoperative hospital stay | perioperative period |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Chen Wang, MD | China-Japan Friednship Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Department of hepatobiliary surgery,China-Japan Friendship Hospital | Beijing | Beijing Municipality | 100029 | China |
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| ID | Term |
|---|---|
| D041761 | Cholecystolithiasis |
| ID | Term |
|---|---|
| D002769 | Cholelithiasis |
| D001660 | Biliary Tract Diseases |
| D004066 | Digestive System Diseases |
| D005705 | Gallbladder Diseases |
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| ID | Term |
|---|---|
| D017081 | Cholecystectomy, Laparoscopic |
| ID | Term |
|---|---|
| D002763 | Cholecystectomy |
| D001662 | Biliary Tract Surgical Procedures |
| D013505 | Digestive System Surgical Procedures |
| D013514 | Surgical Procedures, Operative |
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| 12 and 24 hours after the operation |
| 36-item health survey | 3 months after the operation |
| D010535 | Laparoscopy |
| D004724 | Endoscopy |
| D019060 | Minimally Invasive Surgical Procedures |