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AppendicitisNCT01567098

Single Incision Versus Conventional 3-Port Laparoscopic Appendectomy

A study testing single incision laparoscopic appendectomy in people with Appendicitis, run by Hospital Authority, Hong Kong at 1 site in Hong Kong.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 to 80 years
Conditions the study is for
Appendicitis
What is being tested?
single incision laparoscopic appendectomy
Type of treatment
Surgery or procedure
Could I receive a placebo?
No, everyone receives an active treatment
How many people
120 participants
Where
1 siteHong Kong
Study dates
Jun 2012to Jun 2014
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 80 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

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

Who cannot join

  • pregnancy, mentally incapacitated, previous surgery

Trial locations and contacts

1 site in 1 country.

Canon KO Chan, F.R.C.S.Ed contact

(+852)29588887

chankoc@gmail.com

Hong Kong1 site

  • Department of Surgery

    Kowloon

    Canon KO Chan, F.R.C.S Ed., chankoc@gmail.com

Other trials in Hong Kong

About this study

Official title: Single Incision Versus Conventional 3-Port Laparoscopic Appendectomy: A Single Center Prospective Randomized Trial

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.

Read the 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.

Conditions
Appendicitis
Being tested
single incision laparoscopic appendectomy
Medical subject headings
Appendicitis

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • single incision laparoscopic appendectomyProcedure or surgery

    Also called single port appendectomy, one port appendectomy, SILS

    performing appendectomy through a single incision in the abdomen

Study groups in NCT01567098
Study groupRoleWhat they receive
SILS appendectomyExperimentalSingle incision laparoscopic appendectomy
Receives: Procedure: single incision laparoscopic appendectomy
3 Ports appendectomyActive comparatorperforming appendectomy through conventional 3 incisions on the abdomen
Receives: Procedure: single incision laparoscopic appendectomy

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. operation time

    Measured: 1 year

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted30 Mar 2012 (estimated)
  2. Study startJun 2012
  3. Primary completionJun 2013 (estimated)
  4. Study completionJun 2014 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
120 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01567098
Sponsor's protocol ID
KC/KE-12-0051
Status last verified
May 2012
First submitted
27 Mar 2012
Last updated
30 May 2012
Results posted
No
Data monitoring committee
No

Publications

  • 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.

    PubMed 20940605

  • 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.

    PubMed 21810504

  • 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.

    PubMed 20849304

  • 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.

    PubMed 22101420

  • 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.

    PubMed 22091365

  • 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.

    PubMed 21034942

  • 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.

    PubMed 20927545

  • 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.

    PubMed 20108149

  • 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.

    PubMed 21375838

  • 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.

    PubMed 22002266

  • 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.

    PubMed 21946218

  • 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.

    PubMed 18553045

  • 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.

    PubMed 1303622

  • 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.

    PubMed 19760332

  • 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.

    PubMed 8073350

Questions about this trial

What is this clinical trial studying?

A study testing single incision laparoscopic appendectomy in people with Appendicitis, run by Hospital Authority, Hong Kong at 1 site in Hong Kong.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 30 May 2012. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Hong Kong. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Canon KO Chan, F.R.C.S.Ed ((+852)29588887, chankoc@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

operation time (time frame: 1 year). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01567098, which also lists 17 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 May 2012.

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