Clinical trial NCT01816568: 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
Overall status: COMPLETED
Phase: NA
Conditions: Acute Appendicitis
Keywords: appendicitis, laparoscopy, single incision
Lead sponsor: Maltepe University
Sponsor class: OTHER
First posted: 2013-03-22
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: Pain score
timeFrame: Postoperative first 24 hours
Secondary outcomes:
measure: Intraoperative complications
timeFrame: Average of 50 minutes
measure: Operating time
timeFrame: Average of 50 minutes
measure: Postoperative complications
timeFrame: 24th hour, 2nd day, 3rd day, 7th day, 1st month, 3rd month, 6th month, 1st year
Other outcomes:
measure: Length of hospital stay
timeFrame: Average of 2 days
Locations:
Study officials:
affiliation: Maltepe University School of Medicine, General Surgery Department
name: Ugur Deveci, Assoc.Prof.
role: PRINCIPAL_INVESTIGATOR
affiliation: Sakarya University School of Medicine, General Surgery Department
name: Fatih Altintoprak, Assoc.Prof.
role: PRINCIPAL_INVESTIGATOR
affiliation: Maltepe University School of Medicine, General Surgery Department
name: Manuk Norayk Manukyan, Assoc.Prof.
role: STUDY_DIRECTOR
affiliation: Maltepe University School of Medicine, General Surgery Department
name: Sertan Kapakli, Assoc.Prof.
role: PRINCIPAL_INVESTIGATOR
affiliation: Maltepe University School of Medicine, General Surgery Department
name: Abut Kebudi, Prof.
role: STUDY_CHAIR
References: