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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

50 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-02-28

Study Completion Date

2013-02-28

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Acute Appendicitis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

Study Groups

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Group 1

SILS appendectomy

Group Type ACTIVE_COMPARATOR

SILS appendectomy

Intervention Type PROCEDURE

Single incision laparoscopic appendectomy will be performed

Group 2

Three port laparoscopic appendectomy

Group Type ACTIVE_COMPARATOR

Three port laparoscopic appendectomy

Intervention Type PROCEDURE

Three port laparoscopic appendectomy will be performed

Interventions

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SILS appendectomy

Single incision laparoscopic appendectomy will be performed

Intervention Type PROCEDURE

Three port laparoscopic appendectomy

Three port laparoscopic appendectomy will be performed

Intervention Type PROCEDURE

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes