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Solo and Non-solo Approach for Laparoscopic Appendectomy (SOLOAP)

A Randomized Controlled Trial Comparing a Solo and Non-solo Approach for Laparoscopic Appendectomy

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03224364
Enrollment
150
Registered
2017-07-21
Start date
2017-08-01
Completion date
2018-03-31
Last updated
2017-07-21

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Appendicitis, Laparoscopic

Keywords

Solo surgery, Camera holder, Laparoscopic Appendectomy

Brief summary

To determine the safety and feasibility of solo laparoscopic appendectomy, which is defined as the application of solo surgery to laparoscopic appendectomy, by comparing consecutive non-solo procedures conducted by a surgeon in the presence or absence of human assistant(s).

Detailed description

Laporoscopic appendectomy usually requires three surgeons, including an operator, a camera assistant, and other instrument assistant. Recent advancement of technology made it possible to develop the conveniently adjustable holders for camera and other laparoscopic instruments. The application of these instruments enables solo-surgery wherein an operation is driven by single surgeon. During surgery, human assistant(s) are helpful because of their instant assistance according to the operation's need. Therefore, the utilization of instruments instead of human assistants would be cumbersome. However, the utilization of instruments would be helpful by enabling operation-driven repositioning of the camera and instrument(s). Currently, no attempt has been made to objectively compare the merits and demerits of these two procedures. Therefore, this study was conducted to determine the safety and feasibility of solo laparoscopic appendectomy, which is defined as the application of solo surgery to laparoscopic appendectomy, by comparing consecutive non-solo procedures conducted by a surgeon in the presence or absence of human assistant(s).

Interventions

PROCEDUREnonsolo LA

This patient is scheduled to undergo nonsolo laparoscpic appendectomy.

PROCEDUREsolo LA

This patient is scheduled to undergo solo laparoscpic appendectomy.

Sponsors

Say-June Kim
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)

Eligibility

Sex/Gender
ALL
Age
15 Years to 80 Years
Healthy volunteers
No

Inclusion criteria

1. The patients planned to undergo elective laparoscopic appendectomy 2. Benign gallbladder diseases requiring surgery 3. The patients who are indicated for single-port laparoscopic appendectomy.

Exclusion criteria

1. the patients with complicated cholecystitis 2. the patients with the gallbladder with a thickness more than 4mm. 3. the patients who are expected to have severe peritoneal adhesion. 4. the patients with malignant gallbladder diseases. 5. the patients whose operation appears to need human assistant(s)

Design outcomes

Primary

MeasureTime frameDescription
Operation timeday 1Operation time correlates with surgical difficulity.

Secondary

MeasureTime frameDescription
Pain scoreday 3Daily pain scores are assessed

Contacts

Primary ContactSay-June Kim
sayjunekim@gmail.com+821087737616

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026