The Comparison of Single Incision Laparoscopic Appendectomy and Three Port Laparoscopic Appendectomy
1 other identifier
interventional
50
0 countries
N/A
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Feb 2010
Typical duration for not_applicable
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
February 1, 2010
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 1, 2013
CompletedStudy Completion
Last participant's last visit for all outcomes
February 1, 2013
CompletedFirst Submitted
Initial submission to the registry
March 20, 2013
CompletedFirst Posted
Study publicly available on registry
March 22, 2013
CompletedMarch 22, 2013
March 1, 2013
3 years
March 20, 2013
March 21, 2013
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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.
Postoperative first 24 hours
Secondary Outcomes (3)
Intraoperative complications
Average of 50 minutes
Operating time
Average of 50 minutes
Postoperative complications
24th hour, 2nd day, 3rd day, 7th day, 1st month, 3rd month, 6th month, 1st year
Other Outcomes (1)
Length of hospital stay
Average of 2 days
Study Arms (2)
Group 1
ACTIVE COMPARATORSILS appendectomy
Group 2
ACTIVE COMPARATORThree port laparoscopic appendectomy
Interventions
Three port laparoscopic appendectomy will be performed
Eligibility Criteria
You may qualify if:
- Required laparoscopic cholecystectomy for gallbladder disease.
You may not qualify if:
- American Society of Anesthesiologists score (ASA) more than III,
- Patients had prior abdominal surgery,
- Pregnancy,
- Ongoing peritoneal dialysis,
- Lack of written informed consent.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Ugur Deveci, Assoc.Prof.
Maltepe University School of Medicine, General Surgery Department
- PRINCIPAL INVESTIGATOR
Fatih Altintoprak, Assoc.Prof.
Sakarya University School of Medicine, General Surgery Department
- STUDY DIRECTOR
Manuk Norayk Manukyan, Assoc.Prof.
Maltepe University School of Medicine, General Surgery Department
- PRINCIPAL INVESTIGATOR
Sertan Kapakli, Assoc.Prof.
Maltepe University School of Medicine, General Surgery Department
- STUDY CHAIR
Abut Kebudi, Prof.
Maltepe University School of Medicine, General Surgery Department
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- PARTICIPANT
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Assoc.Prof.
Study Record Dates
First Submitted
March 20, 2013
First Posted
March 22, 2013
Study Start
February 1, 2010
Primary Completion
February 1, 2013
Study Completion
February 1, 2013
Last Updated
March 22, 2013
Record last verified: 2013-03