NCT01567098

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
120

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jun 2012

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 27, 2012

Completed
3 days until next milestone

First Posted

Study publicly available on registry

March 30, 2012

Completed
2 months until next milestone

Study Start

First participant enrolled

June 1, 2012

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2013

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2014

Completed
Last Updated

May 30, 2012

Status Verified

May 1, 2012

Enrollment Period

1 year

First QC Date

March 27, 2012

Last Update Submit

May 28, 2012

Conditions

Appendicitis

Outcome Measures

Primary Outcomes (1)

  • operation time

    1 year

Study Arms (2)

SILS appendectomy

EXPERIMENTAL

Single incision laparoscopic appendectomy

Procedure: single incision laparoscopic appendectomy

3 Ports appendectomy

ACTIVE COMPARATOR

performing appendectomy through conventional 3 incisions on the abdomen

Procedure: single incision laparoscopic appendectomy

Interventions

single incision laparoscopic appendectomyPROCEDURE

performing appendectomy through a single incision in the abdomen

Also known as: single port appendectomy, one port appendectomy, SILS
3 Ports appendectomySILS appendectomy

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • pregnancy, mentally incapacitated, previous surgery

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of Surgery

Kowloon, Hong Kong

Location

Related Publications (17)

  • 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.

    PMID: 20940605RESULT

  • 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.

    PMID: 21810504RESULT

  • 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.

    PMID: 20849304RESULT

  • 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.

    PMID: 22101420RESULT

  • 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.

    PMID: 22091365RESULT

  • 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.

    PMID: 21034942RESULT

  • 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.

    PMID: 20927545RESULT

  • 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.

    PMID: 20108149RESULT

  • 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.

    PMID: 21375838RESULT

  • 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.

    PMID: 22002266RESULT

  • 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.

    PMID: 21946218RESULT

  • 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.

    PMID: 18553045RESULT

  • 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.

    PMID: 1303622RESULT

  • 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.

    PMID: 19760332RESULT

  • 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.

    PMID: 8073350RESULT

  • 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.

    PMID: 7757437RESULT

  • 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.

    PMID: 20972583RESULT

MeSH Terms

Conditions

Appendicitis

Condition Hierarchy (Ancestors)

Intraabdominal InfectionsInfectionsGastroenteritisGastrointestinal DiseasesDigestive System DiseasesCecal DiseasesIntestinal Diseases

Study Officials

  • Canon KO Chan, F.R.C.S Ed.

    Hospital Authority

    PRINCIPAL INVESTIGATOR

Central Study Contacts

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

CONTACT

(+852)29588887chankoc@gmail.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER GOV
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

March 27, 2012

First Posted

March 30, 2012

Study Start

June 1, 2012

Primary Completion

June 1, 2013

Study Completion

June 1, 2014

Last Updated

May 30, 2012

Record last verified: 2012-05

Locations

HK(1)