NCT00816933

Brief Summary

Appendicitis is the most common benign inflammatory disease that requires an operation. Laparoscopic appendectomy using three trocar is generally performed, and reveals good surgical outcomes incluing less pain, early recovey, cosmetic effect et al. However, with using three trocar, there are some problems including pain around trocar insertion sites(three portions), wound infecton and scar at trocar insertion sites. For these reasons, more minimal invasive appendectomy is required, with development of laparoscopic instrument,eventually one port sppectomy is developed. So, the investigators assess post-operative Outcomes according to the Number of Trocar.

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
140

participants targeted

Target at P75+ for phase_1

Timeline
Completed

Started Jan 2009

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

Study Start

First participant enrolled

January 1, 2009

Completed
1 day until next milestone

First Submitted

Initial submission to the registry

January 2, 2009

Completed
3 days until next milestone

First Posted

Study publicly available on registry

January 5, 2009

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2010

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2010

Completed
Last Updated

January 6, 2009

Status Verified

January 1, 2009

Enrollment Period

1 year

First QC Date

January 2, 2009

Last Update Submit

January 5, 2009

Conditions

AppendicitisPainComplications

Keywords

painoperative timescomplicationtime to return for normal lifepain using VAS score

Outcome Measures

Primary Outcomes (1)

  • post-operative pain

    For 7days

Secondary Outcomes (1)

  • cosmetic effect

    for 14days

Study Arms (2)

one port

EXPERIMENTAL

Patients undergo one port appectomy. Skin incision about 2cm size is made upon umbilicus and dissection is performed to make opening. Then, wound retractcor(Alexis) is iserted on opening site and wound is extended. Rubber glove built-in three 5mm trocars is applied over wound retractor. Pneumoperitoneum is achieved via trocar and appendectomy is performed. After appendectomy, wound is repaired.

Procedure: appendectomy

Three ports

ACTIVE COMPARATOR

Paitents will undergo three port appendectomy. 10 mm trocar is inserted on umbilicus, and two 5mm trocas is inserted low abdomen, left flank respectively. Appendectomy is performed vis these trocas. After operation, wounds are repaired.

Procedure: appendectomy

Interventions

appendectomyPROCEDURE

appendectomy according to the number of trocar

Three portsone port

Eligibility Criteria

Age8 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Appendicitis (clinical or radilogical diagnosis)
  • ASA \< 4

You may not qualify if:

  • Appendicitis with palpable mass( clinical or radilogical diagnosis)
  • Patient has bleeding tendency
  • Pregnant

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Dept. of Surgery, Holy Family Hospital, College of Medicine, The Catholic University of Korea

Bucheon-si, Gyunggi Do, 420-717, South Korea

RECRUITING

Related Publications (2)

  • Kye BH, Lee J, Kim W, Kim D, Lee D. Comparative study between single-incision and three-port laparoscopic appendectomy: a prospective randomized trial. J Laparoendosc Adv Surg Tech A. 2013 May;23(5):431-6. doi: 10.1089/lap.2012.0284. Epub 2013 Mar 8.

    PMID: 23473061DERIVED

  • Lee J, Baek J, Kim W. Laparoscopic transumbilical single-port appendectomy: initial experience and comparison with three-port appendectomy. Surg Laparosc Endosc Percutan Tech. 2010 Apr;20(2):100-3. doi: 10.1097/SLE.0b013e3181d84922.

    PMID: 20393336DERIVED

MeSH Terms

Conditions

AppendicitisPain

Interventions

Appendectomy

Condition Hierarchy (Ancestors)

Intraabdominal InfectionsInfectionsGastroenteritisGastrointestinal DiseasesDigestive System DiseasesCecal DiseasesIntestinal DiseasesNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Digestive System Surgical ProceduresSurgical Procedures, Operative

Central Study Contacts

Wook Kim, professor

CONTACT

+82-32-340-7022kimwook@catholic.ac.kr

Junhyun Lee, Instructor

CONTACT

+82-32-340-7026surgeryjun@catholi.ac.kr

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

January 2, 2009

First Posted

January 5, 2009

Study Start

January 1, 2009

Primary Completion

January 1, 2010

Study Completion

January 1, 2010

Last Updated

January 6, 2009

Record last verified: 2009-01

Locations

KR(1)