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

Not Applicable

• Conditions: Complications
• Interventions: Procedure: suprapubic single-incision laparoscopic appendectomy

• Registration Number: NCT02499016
• Lead Sponsor: Nanfang Hospital, Southern Medical University

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2015-03
• Study Start: 2015-06
• Study First Submitted: 2015-06-10
• Study First Submitted QC: 2015-07-13
• Last Update Submitted: 2015-07-13
• Study First Posted: 2015-07-15
• Last Update Posted: 2015-07-15
• Primary Completion: 2017-12
• Study Completion: 2018-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 208

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
suprapubic single-incision laparoscopic appendectomy	suprapubic single-incision laparoscopic appendectomy	single incision laparoscopic surgery will be performed for patients in this group.
conventional multiport appendectomy	suprapubic single-incision laparoscopic appendectomy	Conventional laparoscopic surgery will be performed for patients in this group.

Primary Outcome Measures

Name	Time	Method
incidence of complications	30 days	The early morbidity rate is defined as the event observed during operation and within 30 days after surgery

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Nanfang Hospital, Southern Medical University; 🇨🇳 Guangzhou, Guangdong, China