Trial on Postoperative Outcomes According to the Number of Trocar During Laparoscopic Appendectomy
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ClinicalTrials.gov Identifier: NCT00816933 |
Recruitment Status
: Unknown
Verified January 2009 by The Catholic University of Korea.
Recruitment status was: Recruiting
First Posted
: January 5, 2009
Last Update Posted
: January 6, 2009
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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.
Condition or disease | Intervention/treatment | Phase |
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Appendicitis Pain Complications | Procedure: appendectomy | Phase 1 |
Study Type : | Interventional (Clinical Trial) |
Estimated Enrollment : | 140 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | Single (Investigator) |
Primary Purpose: | Treatment |
Official Title: | Prospective Randomized Trial on the Assessment of Postoperative Outcomes According to the Number of Trocar During Laparoscopic Appendectomy |
Study Start Date : | January 2009 |
Estimated Primary Completion Date : | January 2010 |
Estimated Study Completion Date : | January 2010 |

Arm | Intervention/treatment |
---|---|
Experimental: 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.
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Procedure: appendectomy
appendectomy according to the number of trocar
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Active Comparator: 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. |
Procedure: appendectomy
appendectomy according to the number of trocar
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- post-operative pain [ Time Frame: For 7days ]
- cosmetic effect [ Time Frame: for 14days ]

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Ages Eligible for Study: | 8 Years to 75 Years (Child, Adult, Senior) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- Appendicitis (clinical or radilogical diagnosis)
- ASA < 4
Exclusion Criteria:
- Appendicitis with palpable mass( clinical or radilogical diagnosis)
- Patient has bleeding tendency
- Pregnant

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00816933
Contact: Wook Kim, professor | +82-32-340-7022 | kimwook@catholic.ac.kr | |
Contact: Junhyun Lee, Instructor | +82-32-340-7026 | surgeryjun@catholi.ac.kr |
Korea, Republic of | |
Dept. of Surgery, Holy Family Hospital, College of Medicine, The Catholic University of Korea | Recruiting |
Bucheon, Gyunggi Do, Korea, Republic of, 420-717 | |
Contact: Wook Kim, professor +82-32-340-7022 kimwook@catholic.ac.kr | |
Contact: Junhyun Lee, Instructor +82-32-340-7026 surgeryjun@catholic.ac.kr | |
Principal Investigator: Wook Kim, professor | |
Sub-Investigator: Dongjae Kim, professor | |
Sub-Investigator: Junhyun Lee, Instructor |
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: | Wook Kim. MD, PhD, Professor & Chief |
ClinicalTrials.gov Identifier: | NCT00816933 History of Changes |
Other Study ID Numbers: |
HFHAPPE 01 |
First Posted: | January 5, 2009 Key Record Dates |
Last Update Posted: | January 6, 2009 |
Last Verified: | January 2009 |
Keywords provided by The Catholic University of Korea:
pain operative times complication time to return for normal life pain using VAS score |
Additional relevant MeSH terms:
Appendicitis Intraabdominal Infections Infection Gastroenteritis |
Gastrointestinal Diseases Digestive System Diseases Cecal Diseases Intestinal Diseases |