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

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ClinicalTrials.gov Identifier: NCT02499016
Recruitment Status : Unknown
Verified March 2015 by Nanfang Hospital of Southern Medical University.
Recruitment status was:  Recruiting
First Posted : July 15, 2015
Last Update Posted : July 15, 2015
Sponsor:
Information provided by (Responsible Party):
Nanfang Hospital of 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.

Condition or disease Intervention/treatment Phase
Complications Procedure: suprapubic single-incision laparoscopic appendectomy Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 208 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Suprapubic Single-incision Laparoscopic Appendectomy Versus Conventional Multiport Appendectomy: a Randomized Controlled Trial
Study Start Date : June 2015
Estimated Primary Completion Date : December 2017
Estimated Study Completion Date : December 2018

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 Name: 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 Name: SSILA




Primary Outcome Measures :
  1. 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


Secondary Outcome Measures :
  1. mortality rate [ Time Frame: 30 days ]
  2. cosmetic results [ Time Frame: 30 days ]
    Cosmetic assessment is perform using body image scale and cosmetic scale.

  3. operative time [ Time Frame: intraoperative ]
  4. time to recover [ Time Frame: 14 days ]
  5. 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.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02499016


Contacts
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Contact: Guoxin Li, M.D.,Ph. D. +86-138-0277-1450 gzliguoxin@163.com
Contact: Yanan Wang, M.D +86-150-1875-3181 wyn8116@163.com

Locations
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China, Guangdong
Nanfang Hospital, Southern Medical University Recruiting
Guangzhou, Guangdong, China, 510-515
Contact: Guoxin Li, M.D., Ph.D.    +86-138-0277-1450    gzliguoxin@163.com   
Contact: Yanan Wang, M.D.    +86-150-1875-3181    wyn8116@163.com   
Principal Investigator: Guoxin Li, M.D.,Ph.D.         
Sponsors and Collaborators
Nanfang Hospital of Southern Medical University
Investigators
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Principal Investigator: Guoxin Li, M.D.,Ph. D. Nanfang Hospital, Southern Medical University, China
Publications of Results:
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Responsible Party: Nanfang Hospital of Southern Medical University
ClinicalTrials.gov Identifier: NCT02499016    
Other Study ID Numbers: NFGS-SSILA-01
First Posted: July 15, 2015    Key Record Dates
Last Update Posted: July 15, 2015
Last Verified: March 2015
Keywords provided by Nanfang Hospital of Southern Medical University:
Appendicitis
Appendectomy
Single-incision
Additional relevant MeSH terms:
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Surgical Wound
Wounds and Injuries