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

July 13, 2015 updated by: Nanfang Hospital of Southern Medical University

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

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

208

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

  • Name: Yanan Wang, M.D
  • Phone Number: +86-150-1875-3181
  • Email: wyn8116@163.com

Study Locations

  • China
    • Guangdong
      • Guangzhou, Guangdong, China, 510-515
        • Recruiting
        • Nanfang Hospital, Southern Medical University
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: suprapubic single-incision laparoscopic appendectomy
single incision laparoscopic surgery will be performed for patients in this group.
Procedure: suprapubic single-incision laparoscopic appendectomy
the approach of appendectomy
Other Names:
  • SSILA
Active Comparator: conventional multiport appendectomy
Conventional laparoscopic surgery will be performed for patients in this group.
Procedure: suprapubic single-incision laparoscopic appendectomy
the approach of appendectomy
Other Names:
  • SSILA

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
incidence of complications
Time Frame: 30 days
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
operative time
Time Frame: intraoperative
intraoperative
mortality rate
Time Frame: 30 days
30 days
cosmetic results
Time Frame: 30 days
Cosmetic assessment is perform using body image scale and cosmetic scale.
30 days
time to recover
Time Frame: 14 days
14 days
Pain score
Time Frame: 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.
14 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Nanfang Hospital of Southern Medical University

Investigators

  • Principal Investigator: Guoxin Li, M.D.,Ph. D., Nanfang Hospital, Southern Medical University, China

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2015

Primary Completion (Anticipated)

December 1, 2017

Study Completion (Anticipated)

December 1, 2018

Study Registration Dates

First Submitted

June 10, 2015

First Submitted That Met QC Criteria

July 13, 2015

First Posted (Estimate)

July 15, 2015

Study Record Updates

Last Update Posted (Estimate)

July 15, 2015

Last Update Submitted That Met QC Criteria

July 13, 2015

Last Verified

March 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • NFGS-SSILA-01

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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