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The Comparison of Single Incision Laparoscopic Appendectomy and Three Port Laparoscopic Appendectomy

Primary Purpose

Acute Appendicitis

Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
SILS appendectomy
Three port laparoscopic appendectomy
Sponsored by
Maltepe University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Acute Appendicitis focused on measuring appendicitis, laparoscopy, single incision

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • Required laparoscopic cholecystectomy for gallbladder disease.

Exclusion Criteria:

  • American Society of Anesthesiologists score (ASA) more than III,
  • Patients had prior abdominal surgery,
  • Pregnancy,
  • Ongoing peritoneal dialysis,
  • Lack of written informed consent.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Active Comparator

    Active Comparator

    Arm Label

    Group 1

    Group 2

    Arm Description

    SILS appendectomy

    Three port laparoscopic appendectomy

    Outcomes

    Primary Outcome Measures

    Pain score
    Postoperative pain will be assessed according Visual analog scale from 0 (no pain) to 10 (worst pain imaginable. Postoperative six hour VAS (POSH-VAS) and postoperative first day VAS (POFD-VAS) will be recorded and compared.

    Secondary Outcome Measures

    Intraoperative complications
    Per operative complications will be recorded. Bleeding Iatrogenic injury Bowel perforation Complications associated with increased intra-abdominal pressure
    Operating time
    The operating time will be defined as the time from the first incision to the last suture's placement.
    Postoperative complications
    Postoperative complications will be recorded postoperative follow up. Bleeding Fecal leakage Intrabdominal injury Wound infection Port site hernia

    Full Information

    First Posted
    March 20, 2013
    Last Updated
    March 21, 2013
    Sponsor
    Maltepe University
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    1. Study Identification

    Unique Protocol Identification Number
    NCT01816568
    Brief Title
    The Comparison of Single Incision Laparoscopic Appendectomy and Three Port Laparoscopic Appendectomy
    Official Title
    The Comparison of Single Incision Laparoscopic Appendectomy and Three Port Laparoscopic Appendectomy
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    March 2013
    Overall Recruitment Status
    Completed
    Study Start Date
    February 2010 (undefined)
    Primary Completion Date
    February 2013 (Actual)
    Study Completion Date
    February 2013 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Maltepe University

    4. Oversight

    Data Monitoring Committee
    Yes

    5. Study Description

    Brief Summary
    Laparoscopic techniques have allowed surgeons to perform complicated intrabdominal surgery with minimal trauma. In numerous studies, when conventional laparoscopic appendectomy using 3 ports is compared with open appendectomy, it has advantages of reduced pain, reduced hospital stay, and enhanced cosmetic effects. Single incision laparoscopic surgery (SILS) was developed with the aim of reducing the invasiveness of conventional laparoscopy. In this study the investigators aimed to compare results of SILS appendectomy and three port conventional laparoscopic appendectomy prospectively.
    Detailed Description
    Total of 50 patients who undergoing laparoscopic appendectomy for acute appendicitis will randomly assign to undergo SILS appendectomy group (n = 25) or Three port laparoscopic appendectomy group (n= 25) according to a computer-generated table of random numbers. Demographics (ie, age, gender, body mass index (BMI), American Society of Anesthesiology (ASA) score, need for conversion to a standard or three port laparoscopic appendectomy, need for conversion to an open appendectomy will be recorded. Outcome measures include operative morbidity, operative time, pain score, hospital stay. Morbidity will be evaluated by rates of colonic leak, wound infection, intrabdominal abscess hospital readmission, and hernia.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Acute Appendicitis
    Keywords
    appendicitis, laparoscopy, single incision

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    Participant
    Allocation
    Randomized
    Enrollment
    50 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Group 1
    Arm Type
    Active Comparator
    Arm Description
    SILS appendectomy
    Arm Title
    Group 2
    Arm Type
    Active Comparator
    Arm Description
    Three port laparoscopic appendectomy
    Intervention Type
    Procedure
    Intervention Name(s)
    SILS appendectomy
    Intervention Description
    Single incision laparoscopic appendectomy will be performed
    Intervention Type
    Procedure
    Intervention Name(s)
    Three port laparoscopic appendectomy
    Intervention Description
    Three port laparoscopic appendectomy will be performed
    Primary Outcome Measure Information:
    Title
    Pain score
    Description
    Postoperative pain will be assessed according Visual analog scale from 0 (no pain) to 10 (worst pain imaginable. Postoperative six hour VAS (POSH-VAS) and postoperative first day VAS (POFD-VAS) will be recorded and compared.
    Time Frame
    Postoperative first 24 hours
    Secondary Outcome Measure Information:
    Title
    Intraoperative complications
    Description
    Per operative complications will be recorded. Bleeding Iatrogenic injury Bowel perforation Complications associated with increased intra-abdominal pressure
    Time Frame
    Average of 50 minutes
    Title
    Operating time
    Description
    The operating time will be defined as the time from the first incision to the last suture's placement.
    Time Frame
    Average of 50 minutes
    Title
    Postoperative complications
    Description
    Postoperative complications will be recorded postoperative follow up. Bleeding Fecal leakage Intrabdominal injury Wound infection Port site hernia
    Time Frame
    24th hour, 2nd day, 3rd day, 7th day, 1st month, 3rd month, 6th month, 1st year
    Other Pre-specified Outcome Measures:
    Title
    Length of hospital stay
    Description
    Length of hospital stay will be recorded postoperative period.
    Time Frame
    Average of 2 days

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    65 Years
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    Eligibility Criteria
    Inclusion Criteria: Required laparoscopic cholecystectomy for gallbladder disease. Exclusion Criteria: American Society of Anesthesiologists score (ASA) more than III, Patients had prior abdominal surgery, Pregnancy, Ongoing peritoneal dialysis, Lack of written informed consent.
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Ugur Deveci, Assoc.Prof.
    Organizational Affiliation
    Maltepe University School of Medicine, General Surgery Department
    Official's Role
    Principal Investigator
    First Name & Middle Initial & Last Name & Degree
    Fatih Altintoprak, Assoc.Prof.
    Organizational Affiliation
    Sakarya University School of Medicine, General Surgery Department
    Official's Role
    Principal Investigator
    First Name & Middle Initial & Last Name & Degree
    Manuk Norayk Manukyan, Assoc.Prof.
    Organizational Affiliation
    Maltepe University School of Medicine, General Surgery Department
    Official's Role
    Study Director
    First Name & Middle Initial & Last Name & Degree
    Sertan Kapakli, Assoc.Prof.
    Organizational Affiliation
    Maltepe University School of Medicine, General Surgery Department
    Official's Role
    Principal Investigator
    First Name & Middle Initial & Last Name & Degree
    Abut Kebudi, Prof.
    Organizational Affiliation
    Maltepe University School of Medicine, General Surgery Department
    Official's Role
    Study Chair

    12. IPD Sharing Statement

    Learn more about this trial

    The Comparison of Single Incision Laparoscopic Appendectomy and Three Port Laparoscopic Appendectomy

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