The Comparison of Single Incision Laparoscopic Appendectomy and Three Port Laparoscopic Appendectomy
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Maltepe University
- Enrollment
- 50
- Primary Endpoint
- Pain score
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Single (Participant)
Eligibility Criteria
- Ages
- 18 Years to 65 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
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.
Arms & Interventions
Group 1
SILS appendectomy
Intervention: SILS appendectomy (Procedure)
Group 2
Three port laparoscopic appendectomy
Intervention: Three port laparoscopic appendectomy (Procedure)
Outcomes
Primary Outcomes
Pain score
Time Frame: Postoperative first 24 hours
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 Outcomes
- 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)
Investigators
manuk norayk manukyan
Assoc.Prof.
Maltepe University