The purpose of this study is to determine safety of solo surgery in single incision laparoscopic cholecystectomy (SILC) with a camera holder comparing to a camera operator assisted SILC
This study is a multicenter randomized controlled study. The primary outcome based on non-inferior study design(α=0.05, power (1-β)=0.90); comparing a complications rate between Solo-SILC group and conventional cholecystectomy group (Ca-SILC). Total of 272 patients who were undergoing laparoscopic cholecystectomy for gallbladder disorders will randomly assign to two groups according to a computer-generated table of random numbers Solo-SILC group using a laparoscopic camera holder (n=136) or Ca-SILC group in which a camera operator joins (n=136). . Demographics (i.e., age, gender, body mass index (BMI), American Society of Anesthesiology (ASA) score, indication for operation, need for conversion to open surgery or additional port will be recorded. Outcome including pain, hernia, complication rates, post-cholecystectomy diarrhea, operator's workload will be investigated
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
272
Solo surgery using a camera scope holder in single incision laparoscopic cholecystectomy
conventional single incision laparoscopic cholecystectomy with a scopist
Complication rate in Solo-Single Incision Laparoscopic Cholecystectomy (SILC)
intraoperative and immediate postoperative complications in Solo-SILC comparing with that in laparoscopic cholecystectomy
Time frame: average 2 weeks
complications in both groups
intraoperative and postoperative complications
Time frame: average 2 weeks
Conversion rate
intraoperative conversion rate to open or additional port surgery
Time frame: intraoperative
Incisional hernia
Umbilical incisional hernia incidence
Time frame: average 6 months
Wound, back, and shoulder pain
Access the patient's pain using the visual analog scale
Time frame: postoperative 6 hr, 24 hr, 2 weeks after the operation
Postoperative adverse symptoms after SILC
Diet change, post-cholecystectomy diarrhea
Time frame: average 2weeks after discharge
number of participant with abnormal laboratory values
postoperative laboratory findings on visiting outpatient's clinic
Time frame: average 2weeks after discharge
Operator's workload
Access a operator's workload just after solo surgery comparing to Ca-SILC group using NASA Task Load Index (NASA-TLX) score
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Time frame: intraoperative