Suprapubic Single-incision Laparoscopic Appendectomy Versus Conventional Appendectomy: a Randomized Controlled Trial

Study Overview
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Brief Summary
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Conventional laparoscopic appendectomy(CLA) is the current standard treatment. To obtain additional benefits such as a better cosmetic outcome, the investigators developed a surgical option termed suprapubic single-incision laparoscopic appendectomy (SSILA), which creates a non-visible scar, that was preliminarily shown to be feasible and safe in our previous retrospective studies To further evaluate the feasibility, safety and cosmetic results of this innovative approach, the investigators compared the outcomes of SSILA and CLA by performing a randomized controlled trial.

Official Title
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Suprapubic Single-incision Laparoscopic Appendectomy Versus Conventional Multiport Appendectomy: a Randomized Controlled Trial

Conditions
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Complications

Intervention / Treatment
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* Procedure: suprapubic single-incision laparoscopic appendectomy


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: acute appendicitis or interval appendicitis informed consent Exclusion Criteria: diagnosis of appendicitis was not clinically established (symptoms attributable to urinary or gynecological problems) history of cirrhosis and coagulation disorders suspected or proven malignancy contraindication to general anesthesia (severe cardiac and/or pulmonary disease) inability to give informed consent(severe mental disease) pregnancy BMI>30kg/m2 generalized peritonitis

Ages Eligible for Study
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Minimum Age: 18 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 |
| --- | --- |
| Experimental: suprapubic single-incision laparoscopic appendectomy<br>single incision laparoscopic surgery will be performed for patients in this group. | Procedure: suprapubic single-incision laparoscopic appendectomy<br>* the approach of appendectomy<br>* Other names: SSILA;|
| Active Comparator: conventional multiport appendectomy<br>Conventional laparoscopic surgery will be performed for patients in this group. | Procedure: suprapubic single-incision laparoscopic appendectomy<br>* the approach of appendectomy<br>* Other names: SSILA;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| incidence of complications | The early morbidity rate is defined as the event observed during operation and within 30 days after surgery | 30 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| mortality rate |  | 30 days | 
| cosmetic results | Cosmetic assessment is perform using body image scale and cosmetic scale. | 30 days | 
| operative time |  | intraoperative | 
| time to recover |  | 14 days | 
| Pain score | Postoperative pain is recorded using the visual analog scale (VAS) pain score tool on postoperative day 1, 2, 3 and the day of discharge. | 14 days | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Appendicitis, Appendectomy, Single-incision