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Single-incision Laparoscopic (SILS) Versus Conventional Laparoscopic Appendectomy for the Treatment of Acute Appendicitis

This study has been terminated.
(Planned interim analysis showed worse outcomes in experimental group)
Sponsor:
Collaborator:
Medtronic - MITG
Information provided by (Responsible Party):
University of California, San Francisco
ClinicalTrials.gov Identifier:
NCT00997516
First received: October 15, 2009
Last updated: August 6, 2014
Last verified: August 2014
Results First Received: August 6, 2014  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Condition: Appendicitis
Interventions: Procedure: SILS appendectomy
Procedure: conventional laparoscopic appendectomy

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
The study population consisted of all patients from May 2010 to November 2012 who presented to the emergency department and were diagnosed with acute appendicitis on the basis of clinical and radiographic evaluation.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
88 patients were assessed for eligibility. 5 patients were excluded because the study surgeon was unavailable to perform the procedure. 6 patients declined to participate.

Reporting Groups
  Description
SILS Appendectomy SILS appendectomy: Use of SILS Port to perform laparoscopic appendectomy
Conventional Laparoscopic Appendectomy Conventional laparoscopic appendectomy: conventional laparoscopic removal of the appendix

Participant Flow for 2 periods

Period 1:   Short-term Follow-up (Post Operative)
    SILS Appendectomy   Conventional Laparoscopic Appendectomy
STARTED   37   38 
COMPLETED   37   38 
NOT COMPLETED   0   0 

Period 2:   Long-term Follow-up (After 6 Months)
    SILS Appendectomy   Conventional Laparoscopic Appendectomy
STARTED   37   38 
COMPLETED   31   36 
NOT COMPLETED   6   2 



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
SILS Appendectomy SILS appendectomy: Use of SILS Port to perform laparoscopic appendectomy
Conventional Laparoscopic Appendectomy Conventional laparoscopic appendectomy: conventional laparoscopic removal of the appendix
Total Total of all reporting groups

Baseline Measures
   SILS Appendectomy   Conventional Laparoscopic Appendectomy   Total 
Overall Participants Analyzed 
[Units: Participants]
 37   38   75 
Age 
[Units: Years]
Mean (Standard Deviation)
 34  (11)   35  (12)   34  (10) 
Gender 
[Units: Participants]
     
Female   18   14   32 
Male   19   24   43 
Region of Enrollment 
[Units: Participants]
     
United States   37   38   75 


  Outcome Measures
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1.  Primary:   Pain After Surgery   [ Time Frame: 12 hours post-surgery ]

2.  Secondary:   Operative Time   [ Time Frame: up to 6 hours ]

3.  Secondary:   Procedures Requiring Conversion to Open or Additional Port   [ Time Frame: during surgery , up to 6 hours ]

4.  Secondary:   Visceral or Vascular Injury   [ Time Frame: during surgery, up to 6 hours ]

5.  Secondary:   Length of Stay   [ Time Frame: up to 14 days ]

6.  Secondary:   Wound Infection   [ Time Frame: 6 months ]

7.  Secondary:   Deep Space Infection   [ Time Frame: 6 months ]

8.  Secondary:   Wound Seroma   [ Time Frame: 6 months ]

9.  Secondary:   Time to Return to Work   [ Time Frame: 30 days ]

10.  Secondary:   Readmission Within 30 Days.   [ Time Frame: 30 days ]

11.  Secondary:   Body Image Score at 6 Months   [ Time Frame: 6 months ]

12.  Secondary:   Satisfaction With Physical Appearance of Abdomen and Scars at 6 Months.   [ Time Frame: 6 months ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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  More Information
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Certain Agreements:  
All Principal Investigators ARE employed by the organization sponsoring the study.


Results Point of Contact:  
Name/Title: Jonathan T. Carter, MD, FACS
Organization: University of California, San Francisco
phone: 415-476-0974
e-mail: jonathan.carter@ucsfmedctr.org


Publications of Results:
Edwards C BA. Single incision laparoscopic appendectomy is safe and results in excellent cosmetic outcomes. SAGES 2009 Scientific Session, April 22-29, Phoenix, AZ (abstract only) 2009.

Other Publications:
Chouillard K FA. Single incision appendectomy for acute appendicitis: a preliminary experience. In: SAGES 2009 Scientific Session, April 22-29, Phoenix, AZ (abstract only); 2009.
Kravetz AJ ID, Kia MA. Initial experience in single-port laparoscopic appendectomies. SAGES 2009 Scientific Session, April 22-29, Phoenix, AZ (abstract only)

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: University of California, San Francisco
ClinicalTrials.gov Identifier: NCT00997516     History of Changes
Other Study ID Numbers: UCSF SILS 01
Study First Received: October 15, 2009
Results First Received: August 6, 2014
Last Updated: August 6, 2014
Health Authority: United States: Institutional Review Board