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

Study Overview
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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.

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.

Official Title
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Prospective, Randomized Study of Single Port and Conventional Laparoscopic Appendectomy in Acute Appendicitis

Conditions
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Appendicitis

Intervention / Treatment
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* Procedure: Single port laparoscopic appendectomy
* Procedure: 3 port laparoscopic appendectomy


Participation Criteria
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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

Ages Eligible for Study
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Minimum Age: 7 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Single port<br>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. | Procedure: Single port laparoscopic appendectomy<br>* Single port through the transumbilical 2-cm incision<br>* Other names: single port laparoscopic surgery;|
| Active Comparator: 3 port<br>3 port laparoscopic appendectomy was done by conventional method | Procedure: 3 port laparoscopic appendectomy<br>* 3 trocars was inserted in infraumbilical, left lower quadrant, and suprapubic area<br>* Other names: conventional laparoscopic appendectomy;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Safety | 30 day morbidity and mortality | 1 month | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Efficacy | Operative time | 1 day | 
| Efficacy | Postoperative pain score | 2 days | 
| Efficacy | Postoperative functional recovery | 2 days | 
| Efficacy | Duration of postoperative hospital stay | 7 days | 
| Efficacy | Cost | 7 days |