Cholecystectomy, Laparoscopic
Conditions
Keywords
Single incision, Solo surgery
Brief summary
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
Detailed description
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
Interventions
PROCEDURESolo surgery
Solo surgery using a camera scope holder in single incision laparoscopic cholecystectomy
PROCEDUREoperation with a camera operator in SILC
conventional single incision laparoscopic cholecystectomy with a scopist
Sponsors
Chungbuk National University Hospital
Gyeongsang National University Hospital
Seoul National University Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* all patient need laparoscopic cholecystectomy (check the possibility of routine application of Solo-SILC in clinical practice)
Exclusion criteria
* Mirizzi syndrome * unstable vital sign * no compliance * no consent
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Complication rate in Solo-Single Incision Laparoscopic Cholecystectomy (SILC) | average 2 weeks | intraoperative and immediate postoperative complications in Solo-SILC comparing with that in laparoscopic cholecystectomy |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Conversion rate | intraoperative | intraoperative conversion rate to open or additional port surgery |
| Incisional hernia | average 6 months | Umbilical incisional hernia incidence |
| Wound, back, and shoulder pain | postoperative 6 hr, 24 hr, 2 weeks after the operation | Access the patient's pain using the visual analog scale |
| complications in both groups | average 2 weeks | intraoperative and postoperative complications |
| number of participant with abnormal laboratory values | average 2weeks after discharge | postoperative laboratory findings on visiting outpatient's clinic |
| Operator's workload | intraoperative | Access a operator's workload just after solo surgery comparing to Ca-SILC group using NASA Task Load Index (NASA-TLX) score |
| Postoperative adverse symptoms after SILC | average 2weeks after discharge | Diet change, post-cholecystectomy diarrhea |
Contacts
Primary ContactYoungRok Choi, M.D.
Backup ContactHo-Jeong Jeong, R.N.
Outcome results
None listed