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

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01816568
Enrollment
50
Registered
2013-03-22
Start date
2010-02-28
Completion date
2013-02-28
Last updated
2013-03-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Acute Appendicitis

Keywords

appendicitis, laparoscopy, single incision

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.

Interventions

Single incision laparoscopic appendectomy will be performed

PROCEDUREThree port laparoscopic appendectomy

Three port laparoscopic appendectomy will be performed

Sponsors

Maltepe University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)

Eligibility

Sex/Gender
ALL
Age
18 Years to 65 Years
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.

Design outcomes

Primary

MeasureTime frameDescription
Pain scorePostoperative first 24 hoursPostoperative 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

MeasureTime frameDescription
Intraoperative complicationsAverage of 50 minutesPer operative complications will be recorded. * Bleeding * Iatrogenic injury * Bowel perforation * Complications associated with increased intra-abdominal pressure
Operating timeAverage of 50 minutesThe operating time will be defined as the time from the first incision to the last suture's placement.
Postoperative complications24th hour, 2nd day, 3rd day, 7th day, 1st month, 3rd month, 6th month, 1st yearPostoperative complications will be recorded postoperative follow up. * Bleeding * Fecal leakage * Intrabdominal injury * Wound infection * Port site hernia

Other

MeasureTime frameDescription
Length of hospital stayAverage of 2 daysLength of hospital stay will be recorded postoperative period.

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026