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

Primary Purpose

Appendicitis, Pain, Complications

Status

Unknown status

Phase

Phase 1

Locations

Korea, Republic of

Study Type

Interventional

Intervention

appendectomy

About this trial

This is an interventional treatment trial for Appendicitis focused on measuring pain, operative times, complication, time to return for normal life, pain using VAS score

Eligibility Criteria

8 Years - 75 Years (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

Appendicitis (clinical or radilogical diagnosis)
ASA < 4

Exclusion Criteria:

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

Sites / Locations

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

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

one port

Three ports

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

post-operative pain

Secondary Outcome Measures

cosmetic effect

Full Information

NCT ID

NCT00816933

First Posted

January 2, 2009

Last Updated

January 5, 2009

Sponsor

The Catholic University of Korea

1. Study Identification

Unique Protocol Identification Number

NCT00816933

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

January 2009

Overall Recruitment Status

Unknown status

Study Start Date

January 2009 (undefined)

Primary Completion Date

January 2010 (Anticipated)

Study Completion Date

January 2010 (Anticipated)

3. Sponsor/Collaborators

Name of the Sponsor

The Catholic University of Korea

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Appendicitis, Pain, Complications

Keywords

pain, operative times, complication, time to return for normal life, pain using VAS score

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 1

Interventional Study Model

Parallel Assignment

Masking

Investigator

Allocation

Randomized

Enrollment

140 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

one port

Arm Type

Experimental

Arm Description

Arm Title

Three ports

Arm Type

Active Comparator

Arm Description

Intervention Type

Procedure

Intervention Name(s)

appendectomy

Intervention Description

appendectomy according to the number of trocar

Primary Outcome Measure Information:

Title

post-operative pain

Time Frame

For 7days

Secondary Outcome Measure Information:

Title

cosmetic effect

Time Frame

for 14days

10. Eligibility

Sex

All

Minimum Age & Unit of Time

8 Years

Maximum Age & Unit of Time

75 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Appendicitis (clinical or radilogical diagnosis) ASA < 4 Exclusion Criteria: Appendicitis with palpable mass( clinical or radilogical diagnosis) Patient has bleeding tendency Pregnant

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Wook Kim, professor

Phone

+82-32-340-7022

kimwook@catholic.ac.kr

First Name & Middle Initial & Last Name or Official Title & Degree

Junhyun Lee, Instructor

Phone

+82-32-340-7026

surgeryjun@catholi.ac.kr

Facility Information:

Facility Name

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

City

Bucheon

State/Province

Gyunggi Do

ZIP/Postal Code

420-717

Country

Korea, Republic of

Individual Site Status

Recruiting

Facility Contact: