Clinical trial NCT03018964: Solo Single Incision Laparoscopic Cholecystectomy
Official title: A Prospective Multicenter Randomized Controlled Study for The Safety of Single Incision Laparoscopic Cholecystectomy With a Camera Holder Versus With a Camera Operator
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Cholecystectomy, Laparoscopic
Keywords: Single incision
Solo surgery
Lead sponsor: Seoul National University Hospital
Sponsor class: OTHER
Collaborators: name: Chungbuk National University Hospital
name: Gyeongsang National University Hospital
First posted: 2017-01-12
Enrollment: 272
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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

Eligibility criteria: 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

Primary outcomes:
measure: Complication rate in Solo-Single Incision Laparoscopic Cholecystectomy (SILC)
timeFrame: average 2 weeks
Secondary outcomes:
measure: complications in both groups
timeFrame: average 2 weeks
measure: Conversion rate
timeFrame: intraoperative
measure: Incisional hernia
timeFrame: average 6 months
measure: Wound, back, and shoulder pain
timeFrame: postoperative 6 hr, 24 hr, 2 weeks after the operation
measure: Postoperative adverse symptoms after SILC
timeFrame: average 2weeks after discharge
measure: number of participant with abnormal laboratory values
timeFrame: average 2weeks after discharge
measure: Operator's workload
timeFrame: intraoperative
Other outcomes:
Locations:
Study officials:
affiliation: Medical Research Collaboration Center Seoul National University Bundang Hospital
name: Soyeon Ahn, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References:
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