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The purpose of this study is to scientifically evaluate the safety, efficacy and cosmetic results of transumbilical laparoendoscopic single site cholecystectomy.
As the natural orifice during embryonic, the transumbilical surgery not only can mask the abdominal scar and avoid infection produced by puncturing stomach, vagina or rectum in NOTES,but also can be played by the conventional laparoscopic instruments. TU-LESS (transumbilical laparoendoscopic single site surgery), is considered to be the most feasible NOTES(natural orifice transluminal endoscopic surgery)technology at present. Researches about TU-LESS mostly are case reports and small samples or the control experiments up to now,there are not persuasive randomized controlled trail between TU-LESS and conventional laparoscopic cholecystectomy. So the investigators design this prospective randomized controlled trail to scientifically evaluate the safety, efficacy and cosmetic results of transumbilical laparoendoscopic single site cholecystectomy .
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Laparoscopic Cholecystectomy | Active Comparator | Laparoscopic cholecystectomy（4 ports or 3 ports）will be performed in a routine fashion by one full time faculty member with fellowship training in laparoscopy. |
|
| TU-LESSC | Active Comparator | TU-LESSC will be performed in a routine fashion which is same to CLC（conventional laparoscopic cholecystetomy）by one full time faculty member with fellowship training in laparoscopy through the conventional laparoscopic instruments. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| CLC | Procedure | CLC（4 ports or 3 ports）will be performed in a routine fashion by one full time faculty member with fellowship training in laparoscopy. |
|
| Measure | Description | Time Frame |
|---|---|---|
| the incidence of surgical complications | The primary outcome messures are the incidence of surgical complications caused by the two surgeries.Bleeding,bile duct injury and bile leakage during operation.Wound infection，umbilical hernia，poke holes hernia and biliary fistula after operation. | up to 12 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| transfer rate | TU-LESSC（transumbilical laparoendoscopic single site cholecystectomy）is converted to LC（laparoscopic cholecystectomy）or open sugery;LC is converted to open sugery. | participants will be followed for the duration of hospital stay, an expected average of 5 days |
| quality of life scores |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Yang Liu, master | Contact | +8615001284594 | liuyangzhanglina@163.com | |
| Wei Guo, doctor | Contact | +8613910950019 | guoweipk@yahoo.com.cn |
| Name | Affiliation | Role |
|---|---|---|
| Zhongtao Zhang, doctor | Beijing Friendship Hospital | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Bejing Friendship Hospital | Recruiting | Beijing | Bejing | 100050 | China |
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| ID | Term |
|---|---|
| D042882 | Gallstones |
| ID | Term |
|---|---|
| D002769 | Cholelithiasis |
| D001660 | Biliary Tract Diseases |
| D004066 | Digestive System Diseases |
| D041761 | Cholecystolithiasis |
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| TU-LESSC | Procedure | TU-LESSC will be performed in a routine fashion which is same to CLC by one full time faculty member with fellowship training in laparoscopy through the conventional laparoscopic instruments. |
|
|
Count patients' quality of life scores before sugery and at several time points after operation. |
| up to 12 weeks |
| pain scores | Use VAS（Visual Analogue Score）to count patients' pain scores at several time points after operation. | up to 12 weeks |
| length of hospital stay | participants will be followed for the duration of hospital stay, an expected average of 5 days |
| total cost of hospitalization | participants will be followed for the duration of hospital stay, an expected average of 5 days |
| Cosmetic results | Through the incision length and patients' satisfaction to assess cosmetic results. | 1 month |
| The incidence of adverse events | The adverse events occurred after surgery，regardless of whether they are caused by the tow operations。 Such as nausea, dizziness, urinary retention, vomiting and so on. | up to 12 weeks |
| D005705 |
| Gallbladder Diseases |
| D002137 | Calculi |
| D020763 | Pathological Conditions, Anatomical |
| D013568 | Pathological Conditions, Signs and Symptoms |