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Trial on Postoperative Outcomes According to the Number of Trocar During Laparoscopic Appendectomy
The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified January 2009 by The Catholic University of Korea.
Recruitment status was: Recruiting
Recruitment status was: Recruiting
Sponsor:
The Catholic University of Korea
Information provided by:
The Catholic University of Korea
ClinicalTrials.gov Identifier:
NCT00816933
First received: January 2, 2009
Last updated: January 5, 2009
Last verified: January 2009
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Purpose
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 | Intervention | Phase |
|---|---|---|
| Appendicitis Pain Complications | Procedure: appendectomy | Phase 1 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Intervention Model: Parallel Assignment Masking: Single Blind (Investigator) Primary Purpose: Treatment |
| Official Title: | Prospective Randomized Trial on the Assessment of Postoperative Outcomes According to the Number of Trocar During Laparoscopic Appendectomy |
Resource links provided by NLM:
Further study details as provided by The Catholic University of Korea:
Primary Outcome Measures:
- post-operative pain [ Time Frame: For 7days ]
Secondary Outcome Measures:
- cosmetic effect [ Time Frame: for 14days ]
| Estimated Enrollment: | 140 |
| Study Start Date: | January 2009 |
| Estimated Study Completion Date: | January 2010 |
| Estimated Primary Completion Date: | January 2010 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
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.
|
Procedure: appendectomy
appendectomy according to the number of trocar
|
|
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
|
Eligibility| Ages Eligible for Study: | 8 Years to 75 Years (Child, Adult, Senior) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
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
Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT00816933
Please refer to this study by its ClinicalTrials.gov identifier: NCT00816933
Contacts
| Contact: Wook Kim, professor | +82-32-340-7022 | kimwook@catholic.ac.kr | |
| Contact: Junhyun Lee, Instructor | +82-32-340-7026 | surgeryjun@catholi.ac.kr |
Locations
| 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 | |
Sponsors and Collaborators
The Catholic University of Korea
More Information
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 |
| Study First Received: | January 2, 2009 |
| Last Updated: | January 5, 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 |
ClinicalTrials.gov processed this record on July 21, 2017