2nd Affiliated Hospital, School of Medicine, Zhejiang University, China
Hangzhou, Zhejiang, No.88 Jiefang Road, China
NCT Number: NCT05728463
Laparoscopic cholecystectomy has been accepted and is nowadays considered as the gold standard treatment of gallstones disease. Conventional laparoscopic cholecystectomy (CLC) was defined as three or four port surgery carried out with either French or American position. It reduced post-operative pain and shorten post-operative length of stay compared with open cholecystectomy in a great extent. Single-incision laparoscopic cholecystectomy (SILC) as a revolutionized surgery, the main reason for its widespread use being the following: less post-operative pain, faster recovery, better cosmetics and quicker return to full activities, all resulting in the improvement of post-operative quality of life. SILC uses the umbilicus as a natural orifice allowing easy access to peritoneal cavity, easy conversion to standard laparoscopy and its easy closure, has been widely introduced into the clinical practice for benign gallbladder diseases. SILC can easily hide the surgical scar inside the umbilicus, thus has better cosmetic effect. But the real clinical benefits for patients still remain a matter of debate. In the last 5 years, many studies on SILC have been published, trying to answer the question whether such a new approach is worthwhile or not and whether is safe and cost-effective.Based on the above controversy, we conduct a RCT comparing clinical and peri-operative outcomes, such as quality of life (QOL), of SILC and CLC with the intent to assess the actual indications of the single-incision approach.
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Notify Me18 year–70 year
All sexes
Interventional
Not applicable
Hangzhou, Zhejiang, No.88 Jiefang Road, China
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Laparoscopic cholecystectomy is defined as total or subtotal desection of the gallbladder laparoscopically.
Time frame: 2 years
The quality of life of patients after operation was investigated by a unified SF-36 questionnaire.
Time frame: 2 years
Evaluation of postoperative incisional scarring using the Vancouver Scar Scale.The scar was observed after pressing with a special glass sheet for 2 seconds. The highest score was 15 points, and the lowest score was 0 points. The higher the score, the more serious the scar situation.
Time frame: 2 years
Second Affiliated Hospital, School of Medicine, Zhejiang University
Other
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