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

Nanfang Hospital, Southern Medical University

Status: Unknown

Conditions: Complications

Treatments: Procedure: suprapubic single-incision laparoscopic appendectomy

Study type: Interventional

Funder types: Other

Identifiers

NCT02499016

NFGS-SSILA-01

Details and patient eligibility

About

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.

Enrollment: 208 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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208 participants in 2 patient groups

suprapubic single-incision laparoscopic appendectomy

Experimental group

Description:

single incision laparoscopic surgery will be performed for patients in this group.

Treatment:

Procedure: suprapubic single-incision laparoscopic appendectomy

conventional multiport appendectomy

Active Comparator group

Description:

Conventional laparoscopic surgery will be performed for patients in this group.

Treatment:

Procedure: suprapubic single-incision laparoscopic appendectomy