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

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.

Study Overview

• Status: Completed
• Conditions: Acute Appendicitis
• Intervention / Treatment: Procedure: SILS appendectomy; Procedure: Three port laparoscopic appendectomy

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 Type: Interventional
• Enrollment (Actual): 50
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: SINGLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
ACTIVE_COMPARATOR: Group 1; SILS appendectomy	Procedure: SILS appendectomy; Single incision laparoscopic appendectomy will be performed
ACTIVE_COMPARATOR: Group 2; Three port laparoscopic appendectomy	Procedure: Three port laparoscopic appendectomy; Three port laparoscopic appendectomy will be performed

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Intraoperative complications	Per operative complications will be recorded.; Bleeding; Iatrogenic injury; Bowel perforation; Complications associated with increased intra-abdominal pressure	Average of 50 minutes
Operating time	The operating time will be defined as the time from the first incision to the last suture's placement.	Average of 50 minutes
Postoperative complications	Postoperative complications will be recorded postoperative follow up.; Bleeding; Fecal leakage; Intrabdominal injury; Wound infection; Port site hernia	24th hour, 2nd day, 3rd day, 7th day, 1st month, 3rd month, 6th month, 1st year

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Length of hospital stay	Length of hospital stay will be recorded postoperative period.	Average of 2 days

Collaborators and Investigators

• Sponsor: Maltepe University
• Investigators: 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 record dates

Study Major Dates

• Study Start: February 1, 2010
• Primary Completion (ACTUAL): February 1, 2013
• Study Completion (ACTUAL): February 1, 2013

Study Registration Dates

• First Submitted: March 20, 2013
• First Submitted That Met QC Criteria: March 21, 2013
• First Posted (ESTIMATE): March 22, 2013

Study Record Updates

• Last Update Posted (ESTIMATE): March 22, 2013
• Last Update Submitted That Met QC Criteria: March 21, 2013
• Last Verified: March 1, 2013

More Information

Terms related to this study

• Keywords: appendicitis, laparoscopy, single incision
• Additional Relevant MeSH Terms: Digestive System Diseases; Infections; Gastrointestinal Diseases; Gastroenteritis; Intestinal Diseases; Cecal Diseases; Intraabdominal Infections; Appendicitis
• Other Study ID Numbers: mütf4