search
Back to results

Single Incision Versus Conventional 3-Port Laparoscopic Appendectomy

Primary Purpose

Appendicitis

Status
Unknown status
Phase
Not Applicable
Locations
Hong Kong
Study Type
Interventional
Intervention
single incision laparoscopic appendectomy
Sponsored by
Hospital Authority, Hong Kong
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Appendicitis

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • appendicitis score >5, imaging showed no complication from appendicitis

Exclusion Criteria:

  • pregnancy, mentally incapacitated, previous surgery

Sites / Locations

  • Department of Surgery

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

SILS appendectomy

3 Ports appendectomy

Arm Description

Single incision laparoscopic appendectomy

performing appendectomy through conventional 3 incisions on the abdomen

Outcomes

Primary Outcome Measures

operation time

Secondary Outcome Measures

Full Information

First Posted
March 27, 2012
Last Updated
May 28, 2012
Sponsor
Hospital Authority, Hong Kong
search

1. Study Identification

Unique Protocol Identification Number
NCT01567098
Brief Title
Single Incision Versus Conventional 3-Port Laparoscopic Appendectomy
Official Title
Single Incision Versus Conventional 3-Port Laparoscopic Appendectomy: A Single Center Prospective Randomized Trial
Study Type
Interventional

2. Study Status

Record Verification Date
May 2012
Overall Recruitment Status
Unknown status
Study Start Date
June 2012 (undefined)
Primary Completion Date
June 2013 (Anticipated)
Study Completion Date
June 2014 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Hospital Authority, Hong Kong

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
A randomized trial to study the null hypothesis:" single incision appendectomy does not take longer operation time when compared to conventional 3-port appendectomy". The study will be carried out in a tertiary referral center in Hong Kong with a catchment population of 1 million.
Detailed Description
Since the introduction of single incision laparoscopic surgery (SILS), this approach has become more popular and various case series and reports had described its feasibility in many general surgical procedures including appendectomy, cholecystectomy, and colectomy. Despite this, strong evidence in support of SILS to be equivalent or even superior to conventional multi-port approaches remain scarce, although there are case series and comparative studies with promising results in cholecystectomy and colectomy. There are many case series available stating that single incision appendectomy may be a feasible alternative to conventional approach, but may be at the expense of a longer operating time and a higher post operative wound pain score. A recent randomized trial by St. Peter et al. was the first to test the feasibility of this approach to standard 3-port approach in appendectomy in children. Under randomized settings of this trial the single incision appendectomy produced longer operating times and resulted in greater charges. However, the primary outcome measure in this trial was wound infection and the result showed no significant differences between the two approaches. The answer to whether single incision appendectomy produces a longer operating time when compared to conventional 3-port approach remained undetermined, in particular the adult population, and therefore a randomized trial design based on operating time as its primary outcome is desired.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Appendicitis

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
120 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
SILS appendectomy
Arm Type
Experimental
Arm Description
Single incision laparoscopic appendectomy
Arm Title
3 Ports appendectomy
Arm Type
Active Comparator
Arm Description
performing appendectomy through conventional 3 incisions on the abdomen
Intervention Type
Procedure
Intervention Name(s)
single incision laparoscopic appendectomy
Other Intervention Name(s)
single port appendectomy, one port appendectomy, SILS
Intervention Description
performing appendectomy through a single incision in the abdomen
Primary Outcome Measure Information:
Title
operation time
Time Frame
1 year

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: appendicitis score >5, imaging showed no complication from appendicitis Exclusion Criteria: pregnancy, mentally incapacitated, previous surgery
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Canon KO Chan, F.R.C.S.Ed
Phone
(+852)29588887
Email
chankoc@gmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Canon KO Chan, F.R.C.S Ed.
Organizational Affiliation
Hospital Authority
Official's Role
Principal Investigator
Facility Information:
Facility Name
Department of Surgery
City
Kowloon
Country
Hong Kong
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Canon KO Chan, F.R.C.S Ed.
Email
chankoc@gmail.com

12. IPD Sharing Statement

Citations:
PubMed Identifier
20940605
Citation
Adair J, Gromski MA, Lim RB, Nagle D. Single-incision laparoscopic right colectomy: experience with 17 consecutive cases and comparison with multiport laparoscopic right colectomy. Dis Colon Rectum. 2010 Nov;53(11):1549-54. doi: 10.1007/DCR.0b013e3181e85875.
Results Reference
result
PubMed Identifier
21810504
Citation
Adair J, Gromski MA, Nagle D. Single-incision laparoscopic sigmoidectomy and rectopexy case series. Am J Surg. 2011 Aug;202(2):243-5. doi: 10.1016/j.amjsurg.2010.08.034.
Results Reference
result
PubMed Identifier
20849304
Citation
Agha A, Hornung M, Iesalnieks I, Glockzin G, Schlitt HJ. Single-incision retroperitoneoscopic adrenalectomy and single-incision laparoscopic adrenalectomy. J Endourol. 2010 Nov;24(11):1765-70. doi: 10.1089/end.2010.0238. Epub 2010 Sep 19.
Results Reference
result
PubMed Identifier
22101420
Citation
Fujii S, Watanabe K, Ota M, Watanabe J, Ichikawa Y, Yamagishi S, Tatsumi K, Suwa H, Kunisaki C, Taguri M, Morita S, Endo I. Single-incision laparoscopic surgery using colon-lifting technique for colorectal cancer: a matched case-control comparison with standard multiport laparoscopic surgery in terms of short-term results and access instrument cost. Surg Endosc. 2012 May;26(5):1403-11. doi: 10.1007/s00464-011-2047-9. Epub 2011 Nov 20.
Results Reference
result
PubMed Identifier
22091365
Citation
Raakow R, Jacob DA. Single-Incision Cholecystectomy in about 200 Patients. Minim Invasive Surg. 2011;2011:915735. doi: 10.1155/2011/915735. Epub 2011 Jul 2.
Results Reference
result
PubMed Identifier
21034942
Citation
Chandler NM, Danielson PD. Single-incision laparoscopic appendectomy vs multiport laparoscopic appendectomy in children: a retrospective comparison. J Pediatr Surg. 2010 Nov;45(11):2186-90. doi: 10.1016/j.jpedsurg.2010.07.012.
Results Reference
result
PubMed Identifier
20927545
Citation
Chiu CG, Nguyen NH, Bloom SW. Single-incision laparoscopic appendectomy using conventional instruments: an initial experience using a novel technique. Surg Endosc. 2011 Apr;25(4):1153-9. doi: 10.1007/s00464-010-1332-3. Epub 2010 Oct 7.
Results Reference
result
PubMed Identifier
20108149
Citation
Chouillard E, Dache A, Torcivia A, Helmy N, Ruseykin I, Gumbs A. Single-incision laparoscopic appendectomy for acute appendicitis: a preliminary experience. Surg Endosc. 2010 Aug;24(8):1861-5. doi: 10.1007/s00464-009-0860-1. Epub 2010 Jan 28.
Results Reference
result
PubMed Identifier
21375838
Citation
Feinberg EJ, O'Connor DJ, Feinberg ML, Vemulapalli P, Camacho D. Single-incision laparoscopic appendectomy: an early experience. Am Surg. 2011 Mar;77(3):286-9. doi: 10.1177/000313481107700315.
Results Reference
result
PubMed Identifier
22002266
Citation
Goel R, Buhari SA, Foo J, Chung LK, Wen VL, Agarwal A, Lomanto D. Single-incision laparoscopic appendectomy: prospective case series at a single centre in Singapore. Surg Laparosc Endosc Percutan Tech. 2011 Oct;21(5):318-21. doi: 10.1097/SLE.0b013e3182311bd9.
Results Reference
result
PubMed Identifier
21946218
Citation
St Peter SD, Adibe OO, Juang D, Sharp SW, Garey CL, Laituri CA, Murphy JP, Andrews WS, Sharp RJ, Snyder CL, Holcomb GW 3rd, Ostlie DJ. Single incision versus standard 3-port laparoscopic appendectomy: a prospective randomized trial. Ann Surg. 2011 Oct;254(4):586-90. doi: 10.1097/SLA.0b013e31823003b5.
Results Reference
result
PubMed Identifier
18553045
Citation
Andersson M, Andersson RE. The appendicitis inflammatory response score: a tool for the diagnosis of acute appendicitis that outperforms the Alvarado score. World J Surg. 2008 Aug;32(8):1843-9. doi: 10.1007/s00268-008-9649-y. Erratum In: World J Surg. 2012 Sep;36(9):2269-70.
Results Reference
result
PubMed Identifier
1303622
Citation
Bone RC, Balk RA, Cerra FB, Dellinger RP, Fein AM, Knaus WA, Schein RM, Sibbald WJ. Definitions for sepsis and organ failure and guidelines for the use of innovative therapies in sepsis. The ACCP/SCCM Consensus Conference Committee. American College of Chest Physicians/Society of Critical Care Medicine. Chest. 1992 Jun;101(6):1644-55. doi: 10.1378/chest.101.6.1644.
Results Reference
result
PubMed Identifier
19760332
Citation
Lin YY, Shabbir A, So JB. Laparoscopic appendectomy by residents: evaluating outcomes and learning curve. Surg Endosc. 2010 Jan;24(1):125-30. doi: 10.1007/s00464-009-0691-0.
Results Reference
result
PubMed Identifier
8073350
Citation
Meinke AK, Kossuth T. What is the learning curve for laparoscopic appendectomy? Surg Endosc. 1994 May;8(5):371-5; discussion 376. doi: 10.1007/BF00642433.
Results Reference
result
PubMed Identifier
7757437
Citation
McKernan JB, Champion JK. Access techniques: Veress needle--initial blind trocar insertion versus open laparoscopy with the Hasson trocar. Endosc Surg Allied Technol. 1995 Feb;3(1):35-8.
Results Reference
result
PubMed Identifier
20972583
Citation
Teoh AY, Chiu PW, Wong TC, Wong SK, Lai PB, Ng EK. A case-controlled comparison of single-site access versus conventional three-port laparoscopic appendectomy. Surg Endosc. 2011 May;25(5):1415-9. doi: 10.1007/s00464-010-1406-2. Epub 2010 Oct 23.
Results Reference
result

Learn more about this trial

Single Incision Versus Conventional 3-Port Laparoscopic Appendectomy

We'll reach out to this number within 24 hrs