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

Sponsor
Say-June Kim (Other)
Overall Status
Unknown status
CT.gov ID
NCT03224364
Collaborator
(none)
150
Enrollment
2
Arms
8
Anticipated Duration (Months)

Study Details

Study Description

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).

Condition or Disease Intervention/Treatment Phase
  • Procedure: nonsolo LA
  • Procedure: solo LA
 N/A

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).

Study Design

Study Type:
Interventional
Anticipated Enrollment :
150 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Double (Participant, Investigator)
Primary Purpose:
Treatment
Official Title:
A Randomized Controlled Trial Comparing a Solo and Non-solo Approach for Laparoscopic Appendectomy
Anticipated Study Start Date :
Aug 1, 2017
Anticipated Primary Completion Date :
Dec 31, 2017
Anticipated Study Completion Date :
Mar 31, 2018

Arms and Interventions

Arm Intervention/Treatment
Placebo Comparator: LC & nonsolo approach

The surgical intervention is nonsolo LC

Procedure: nonsolo LA
This patient is scheduled to undergo nonsolo laparoscpic appendectomy.
Other Names:
  • Nonsolo laparoscopic appendectomy

    		•
    Active Comparator: LC & solo approach

    The surgical intervention is solo LC.

    Procedure: solo LA
    This patient is scheduled to undergo solo laparoscpic appendectomy.
    Other Names:
  • Solo laparoscopic appendectomy

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Operation time [day 1]

      Operation time correlates with surgical difficulity.

    Secondary Outcome Measures

    1. Pain score [day 3]

      Daily pain scores are assessed

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    15 Years to 80 Years
    Sexes Eligible for Study:
    All
    Accepts 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)

    Contacts and Locations

    Locations

    No locations specified.

    Sponsors and Collaborators

    • Say-June Kim

    Investigators

    • Principal Investigator: Say-June Kim, M.D., Ph.D., Daejeon St. Mary's hospital, the Catholic University of Korea, 222, Banpo-dong, Seocho-gu, Seoul, 06591, South Korea

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Say-June Kim, Professor, Daejeon St. Mary's hospital
    ClinicalTrials.gov Identifier:
    NCT03224364
    Other Study ID Numbers:
    • SSAP-1
    First Posted:
    Jul 21, 2017
    Last Update Posted:
    Jul 21, 2017
    Last Verified:
    Jul 1, 2017
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by Say-June Kim, Professor, Daejeon St. Mary's hospital
    Solo surgery
    Camera holder
    Laparoscopic Appendectomy
    Additional relevant MeSH terms:
    Appendicitis

    Study Results

    No Results Posted as of Jul 21, 2017