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

Acute Appendicitis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01816568
• Other study ID #: mütf4
• Status: Completed
• Phase: N/A
• First received: March 20, 2013
• Last updated: March 21, 2013
• Start date: February 2010
• Est. completion date: February 2013

Study information

• Verified date: March 2013
• Source: Maltepe University
• Contact: n/a
• Is FDA regulated: No
• Health authority: Turkey: Ministry of Health
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 50
• Est. completion date: February 2013
• Est. primary completion date: February 2013
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Acute Appendicitis
• Appendicitis

Intervention

Procedure:
• SILS appendectomy
Single incision laparoscopic appendectomy will be performed
• Three port laparoscopic appendectomy
Three port laparoscopic appendectomy will be performed

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Maltepe University

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Length of hospital stay	Length of hospital stay will be recorded postoperative period.	Average of 2 days	No
Primary	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	No
Secondary	Intraoperative complications	Per operative complications will be recorded.; Bleeding; Iatrogenic injury; Bowel perforation; Complications associated with increased intra-abdominal pressure	Average of 50 minutes	Yes
Secondary	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	No
Secondary	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	Yes