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