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

M

Maltepe University

Status

Completed

Conditions

Acute Appendicitis

Treatments

Procedure: Three port laparoscopic appendectomy
Procedure: SILS appendectomy

Study type

Interventional

Funder types

Other

Identifiers

Details and patient eligibility

About

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.

Full 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.

Enrollment

50 patients

Sex

All

Ages

18 to 65 years old

Volunteers

Accepts Healthy Volunteers

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.

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Single Blind

50 participants in 2 patient groups

Group 1
Active Comparator group
Description:
SILS appendectomy
Treatment:
Procedure: SILS appendectomy
Group 2
Active Comparator group
Description:
Three port laparoscopic appendectomy
Treatment:
Procedure: Three port laparoscopic appendectomy

Trial contacts and locations

0

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Data sourced from clinicaltrials.gov

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