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

Complications Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02499016
• Other study ID #: NFGS-SSILA-01
• Status: Recruiting
• Phase: N/A
• First received: June 10, 2015
• Last updated: July 13, 2015
• Start date: June 2015
• Est. completion date: December 2018

Study information

• Verified date: March 2015
• Source: Nanfang Hospital of Southern Medical University
• Contact: Guoxin Li, M.D.,Ph. D.
• Phone: +86-138-0277-1450
• Email: gzliguoxin[@]163.com
• Is FDA regulated: No
• Health authority: China: Ministry of Health
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 208
• Est. completion date: December 2018
• Est. primary completion date: December 2017
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Complications

Intervention

Procedure:
• suprapubic single-incision laparoscopic appendectomy
the approach of appendectomy

Locations

Country	Name	City	State
China	Nanfang Hospital, Southern Medical University	Guangzhou	Guangdong

Sponsors (1)

Lead Sponsor	Collaborator
Nanfang Hospital of Southern Medical University

Country where clinical trial is conducted

China, 

References & Publications (2)

Wang Y, Xiong W, Lan X, Zhang J, Chen T, Liu H, Li G. Suprapubic single incision laparoscopic appendectomy. J Surg Res. 2015 Feb;193(2):577-82. doi: 10.1016/j.jss.2014.07.064. Epub 2014 Aug 4. — View Citation

Yu J, Wang YN, Hu YF, Cheng X, Zhen L, Li GX. Single-incision laparoscopic appendectomy performed above the pubic symphysis - a new scarless approach. Minim Invasive Ther Allied Technol. 2011 Jan;20(1):18-21. doi: 10.3109/13645706.2010.518672. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	incidence of complications	The early morbidity rate is defined as the event observed during operation and within 30 days after surgery	30 days	Yes
Secondary	mortality rate		30 days	Yes
Secondary	cosmetic results	Cosmetic assessment is perform using body image scale and cosmetic scale.	30 days	No
Secondary	operative time		intraoperative	No
Secondary	time to recover		14 days	No
Secondary	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	No