Trial on Postoperative Outcomes According to the Number of Trocar During Laparoscopic Appendectomy

NCT ID: NCT00816933

Last Updated: 2009-01-06

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

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE1

Total Enrollment

140 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-01-31

Study Completion Date

2010-01-31

Brief Summary

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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.

Detailed Description

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Conditions

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Appendicitis Pain Complications

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Investigators

Study Groups

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one port

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.

Group Type EXPERIMENTAL

appendectomy

Intervention Type PROCEDURE

appendectomy according to the number of trocar

Three ports

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.

Group Type ACTIVE_COMPARATOR

appendectomy

Intervention Type PROCEDURE

appendectomy according to the number of trocar

Interventions

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appendectomy

appendectomy according to the number of trocar

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

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

Exclusion Criteria

* Appendicitis with palpable mass( clinical or radilogical diagnosis)
* Patient has bleeding tendency
* Pregnant
Minimum Eligible Age

8 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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The Catholic University of Korea

OTHER

Sponsor Role lead

Responsible Party

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Professor & Chief

Locations

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

Bucheon-si, Gyunggi Do, South Korea

Site Status RECRUITING

Countries

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South Korea

Central Contacts

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Wook Kim, professor

Role: CONTACT

+82-32-340-7022

Junhyun Lee, Instructor

Role: CONTACT

+82-32-340-7026

Facility Contacts

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Wook Kim, professor

Role: primary

+82-32-340-7022

Junhyun Lee, Instructor

Role: backup

+82-32-340-7026

References

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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.

Reference Type DERIVED
PMID: 23473061 (View on PubMed)

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.

Reference Type DERIVED
PMID: 20393336 (View on PubMed)

Other Identifiers

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HFHAPPE 01

Identifier Type: -

Identifier Source: org_study_id

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