Single-incision Laparoscopic Surgery in Acute Abdomen

Study Overview
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Brief Summary
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Since Semm et.al. reported the first case of laparoscopic appendectomy in 1983, minimally invasive surgery has become the main stay for treating of many surgical diseases. After the booming in the advancement of surgical instrument and breakthrough in surgical skills, the minimally invasive surgery has been widely applied to neurosurgery, spinal surgery, breast, thyroid, hernia surgery, etc. It has been proved that minimally invasive surgery is safe and effective, and further it achieves compatible results and outcomes in oncology and functional diseases. Minimally invasive surgery in alimentary tract, known as laparoscopic surgery, has been performed in gastric surgery (e.g. gastric cancer, tumor, functional disorders and bariatric surgery), hepatobiliary and pancreatic surgery (e.g. hepatectomy, cholecystectomy, and pancreatectomy), and colorectal surgery (e.g. colorectal cancer and functional bowel disease). Under a superior heritage of surgical skills from Taiwan university hospital, we introduced laparoscopic surgery in 1996 and currently, laparoscopic surgery becomes the mainstay of surgery in Yunlin branch. In 2015, there were 600 laparoscopic surgery in our hospital, while 150 colorectal laparoscopic surgery in the same year. In recent years, single-incisional laparoscopic surgery has emerged to become one of the focused topic in the world and seemly in our department. Through single-incision surgery, we attempted to minimize the incision wound to achieve better cosmesis and faster recovery. By the valuable clinical experiences gathering in our hospital (Yunlin branch) in recent 10 years, we contemplate two-step plans: first, by retrospective data collection, we can explain the clinical problems based on current statistical results. Second, based on prior (step 1) retrospective findings, a prospective study could be conducted for more evident results.

Detailed Description
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The aim of this study is to compare two kinds of single-incision laparoscopic surgery setting including hand-made glove setting and commercialized single-incision multiport setting. The preoperative, intraoperative and postoperative data will be collected for analysis.

Official Title
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The Application of Minimally Invasive Single-incision Laparoscopic Surgery in Acute Abdomen

Conditions
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Acute Appendicitis

Intervention / Treatment
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* Procedure: Hand-made glove setting
* Procedure: Commercialized single-incision multiport setting


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: The patients admitted to the NTUH Yunlin branch diagnosed clinically as acute appendicitis The patients with clinically suspected right lower quadrant pain and acute appendicitis could not be excluded Exclusion Criteria: Not eligible to underwent laparoscopic surgery because of compromised cardiopulmonary function or major laparotomy surgery Decide to receive non-surgical treatment of the acute appendicitis Age<20, or could not exercise the right of autonomy or unwilling to participate the study

Ages Eligible for Study
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Minimum Age: 20 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: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Hand-made glove setting<br>The patients receive Hand-made glove setting | Procedure: Hand-made glove setting<br>* The patients receive Hand-made glove setting for single-incision laparoscopic appendectomy<br>|
| Experimental: commercialized multiport setting<br>The patients receive commercialized single-incision multiport setting | Procedure: Commercialized single-incision multiport setting<br>* The patients receive commercialized single-incision multiport setting for single-incision laparoscopic appendectomy<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Postoperative pain | Postoperative pain is measured by visual pain scale | around 2 years | 
| wound cosmesis | The cosmesis is measure by the length of the incision | around 2 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Operative time | By chart review | around 2 years | 
| Visceral/vascular injuries | Recorded on the operative note | around 2 years | 
| Conversion | Recorded on the operative note | around 2 years | 
| Wound infection/surgical site infection | By chart review | around 2 years | 
| Intra-abdominal collection | Defined by evidence on any image modalities | around 2 years | 
| Postoperative ileus | Defined by ileus physically or by image | around 2 years | 
| Length of hospitalization | By chart review | around 2 years | 
| Time to return work | By chart review | around 2 years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Laparoscopic appendectomy, Single-incision laparoscopic appendectomy, Single-incision laparoscopic surgery setting, Simple appendicitis, Complicated appendicitis