Single Incision Versus Conventional 3-Port Laparoscopic Appendectomy

NCT ID: NCT01567098

Last Updated: 2012-05-30

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

120 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-06-30

Study Completion Date

2014-06-30

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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

See the medical conditions and disease areas that this research is targeting or investigating.

Appendicitis

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

SILS appendectomy

Single incision laparoscopic appendectomy

Group Type EXPERIMENTAL

single incision laparoscopic appendectomy

Intervention Type PROCEDURE

performing appendectomy through a single incision in the abdomen

3 Ports appendectomy

performing appendectomy through conventional 3 incisions on the abdomen

Group Type ACTIVE_COMPARATOR

single incision laparoscopic appendectomy

Intervention Type PROCEDURE

performing appendectomy through a single incision in the abdomen

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

single incision laparoscopic appendectomy

performing appendectomy through a single incision in the abdomen

Intervention Type PROCEDURE

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

single port appendectomy one port appendectomy SILS

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

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

Exclusion Criteria

* pregnancy, mentally incapacitated, previous surgery
Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Hospital Authority, Hong Kong

OTHER_GOV

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

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

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

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

Role: PRINCIPAL_INVESTIGATOR

Hospital Authority

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Department of Surgery

Kowloon, , Hong Kong

Site Status

Countries

Review the countries where the study has at least one active or historical site.

Hong Kong

Central Contacts

Reach out to these primary contacts for questions about participation or study logistics.

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

Role: CONTACT

(+852)29588887

Facility Contacts

Find local site contact details for specific facilities participating in the trial.

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

Role: primary

References

Explore related publications, articles, or registry entries linked to this study.

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.

Reference Type RESULT
PMID: 20940605 (View on PubMed)

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.

Reference Type RESULT
PMID: 21810504 (View on PubMed)

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.

Reference Type RESULT
PMID: 20849304 (View on PubMed)

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.

Reference Type RESULT
PMID: 22101420 (View on PubMed)

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.

Reference Type RESULT
PMID: 22091365 (View on PubMed)

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.

Reference Type RESULT
PMID: 21034942 (View on PubMed)

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.

Reference Type RESULT
PMID: 20927545 (View on PubMed)

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.

Reference Type RESULT
PMID: 20108149 (View on PubMed)

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.

Reference Type RESULT
PMID: 21375838 (View on PubMed)

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.

Reference Type RESULT
PMID: 22002266 (View on PubMed)

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.

Reference Type RESULT
PMID: 21946218 (View on PubMed)

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.

Reference Type RESULT
PMID: 18553045 (View on PubMed)

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.

Reference Type RESULT
PMID: 1303622 (View on PubMed)

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.

Reference Type RESULT
PMID: 19760332 (View on PubMed)

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.

Reference Type RESULT
PMID: 8073350 (View on PubMed)

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.

Reference Type RESULT
PMID: 7757437 (View on PubMed)

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.

Reference Type RESULT
PMID: 20972583 (View on PubMed)

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

KC/KE-12-0051

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

Multicenter Single-port Colectomy RCT
NCT01480128 APPROVED_FOR_MARKETING
Single Port Laparoscopic Colectomy
NCT01320267 WITHDRAWN PHASE1/PHASE2