Solo Single Incision Laparoscopic Cholecystectomy

Seoul National University

Status: Unknown

Conditions: Cholecystectomy, Laparoscopic

Treatments: Procedure: Solo surgery; Procedure: operation with a camera operator in SILC

Study type: Interventional

Funder types: Other

Identifiers

NCT03018964

SILC_HoOp

Details and patient eligibility

About

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

Full 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

Enrollment: 272 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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272 participants in 2 patient groups

Solo-SILC

Experimental group

Description:

Solo surgery using a laparoscopic camera holder instead of a camera operator in SILC

Treatment:

Procedure: Solo surgery

Ca-SILC

Active Comparator group

Description:

No solo surgery, operation with a camera operator in SILC

Treatment:

Procedure: operation with a camera operator in SILC