Safety and Efficacy Study of Single Port Laparoscopic Appendectomy in Acute Appendicitis

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

194 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-12-31

Study Completion Date

2016-02-29

Brief Summary

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The aim of this study is to investigate the safety and efficacy of single port laparoscopic appendectomy compared with conventional laparoscopic appendectomy in adults with acute appendicitis.

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Detailed Description

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Laparoscopic appendectomy improved the postoperative functional outcomes in the treatment of acute appendectomy. In addition, recently single port laparoscopic surgery was introduced in the laparoscopy-dedicated center. When compared with conventional 3 port laparoscopic appendectomy, single port laparoscopic appendectomy was expected to be less painful, more rapid recovery of bowel function, and better cosmetic. In this prospective randomized trial, we tried to investigate the superiority of this new technique in adult patients with acute appendectomy.

Conditions

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Appendicitis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Single port

Single port through the transumbilical incision was made by wound retractor combined with surgical glove and then 3 trocal was inserted to the finger part of the surgical glove. Laparoscopic instrument was working through the single port and resected appendix removed through it.

Group Type ACTIVE_COMPARATOR

Single port laparoscopic appendectomy

Intervention Type PROCEDURE

Single port through the transumbilical 2-cm incision

3 port

3 port laparoscopic appendectomy was done by conventional method

Group Type ACTIVE_COMPARATOR

3 port laparoscopic appendectomy

Intervention Type PROCEDURE

3 trocars was inserted in infraumbilical, left lower quadrant, and suprapubic area

Interventions

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Single port laparoscopic appendectomy

Single port through the transumbilical 2-cm incision

Intervention Type PROCEDURE

3 port laparoscopic appendectomy

3 trocars was inserted in infraumbilical, left lower quadrant, and suprapubic area

Intervention Type PROCEDURE

Other Intervention Names

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single port laparoscopic surgery conventional laparoscopic appendectomy

Eligibility Criteria

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Inclusion Criteria

* Clinically diagnosed acute appendicitis

Exclusion Criteria

* Age less than 7 or more than 75 years old
* Gangrenous appendicitis
* Combined generalized peritonitis
* ASA score more than 3 point
* Pregnant women
* Cases requiring draining tube

Minimum Eligible Age

7 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No