Study on Laparoscopic Operation for Perforated Appendicitis
Recruitment status was Recruiting
| Tracking Information | |||||
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| First Received Date ICMJE | May 13, 2008 | ||||
| Last Updated Date | February 6, 2009 | ||||
| Start Date ICMJE | May 2008 | ||||
| Estimated Primary Completion Date | December 2010 (final data collection date for primary outcome measure) | ||||
| Current Primary Outcome Measures ICMJE |
paraoperative outcomes [ Time Frame: till patients are discharged ] [ Designated as safety issue: Yes ] | ||||
| Original Primary Outcome Measures ICMJE | Same as current | ||||
| Change History | Complete list of historical versions of study NCT00677989 on ClinicalTrials.gov Archive Site | ||||
| Current Secondary Outcome Measures ICMJE |
levels of paraoperative serum cytokines, free radicals, and oxidized proteins. [ Time Frame: since preoperative preparation till 48 hours after operation ] [ Designated as safety issue: No ] | ||||
| Original Secondary Outcome Measures ICMJE | Same as current | ||||
| Current Other Outcome Measures ICMJE | Not Provided | ||||
| Original Other Outcome Measures ICMJE | Not Provided | ||||
| Descriptive Information | |||||
| Brief Title ICMJE | Study on Laparoscopic Operation for Perforated Appendicitis | ||||
| Official Title ICMJE | The Role of Oxidized Proteins and Free Radicals on Laparoscopic Operation for Perforated Appendicitis | ||||
| Brief Summary | The purpose of this study is to conduct a prospective observational study for the open approach and laparoscopic approach for perforated appendicitis. It is also designed to investigate if carbon dioxide pneumoperitoneum will have unwanted effect when treating perforated appendicitis with laparoscopic operation. |
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| Detailed Description | The role of laparoscopic appendectomy (LA) for perforated appendicitis is under investigation. According to the results of a previous retrospective study conducted in Far-Eastern Memorial Hospital comparing the clinical outcomes between perforated appendicitis patients treated by laparoscopic and open approach showed favored clinical outcomes for LA. Same as a few studies indicated that laparoscopic appendectomy is a safe and effective procedure for treating patients with perforated appendicitis in terms of hospital stay and wound complications. One the other hand, some authors still concern about the adverse effects of laparoscopy for ruptured appendicitis patients in terms of longer operation time and increased rates of postoperative abscess formation. We hypothesize that prolonged CO2 pneumoperitoneum will produce transient mesenteric ischemic and reperfusion injury when CO2 disinflation, and the free radicals and oxidative proteins provoked by reperfusion injury are responsible for the adverse reaction of LA. The objective of this prospective non-randomized controlled study is to examine the safety and efficacy of laparoscopic appendectomy and compare its outcome with that of the conventional approach for perforated appendicitis patients, with special emphasis on postoperative complication and oxidative stress resulted from pneumoperitoneum.. |
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| Study Type ICMJE | Observational | ||||
| Study Design ICMJE | Observational Model: Case Control Time Perspective: Prospective |
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| Target Follow-Up Duration | Not Provided | ||||
| Biospecimen | Retention: Samples Without DNA Description: serum |
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| Sampling Method | Probability Sample | ||||
| Study Population | Patients with perforated appendicitis treated at the Far-Eastern Memorial Hospital, Taipei,Taiwan |
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| Condition ICMJE | Perforated Appendicitis | ||||
| Intervention ICMJE |
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| Study Group/Cohort (s) |
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| Publications * |
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||
| Recruitment Status ICMJE | Recruiting | ||||
| Estimated Enrollment ICMJE | 60 | ||||
| Estimated Completion Date | December 2010 | ||||
| Estimated Primary Completion Date | December 2010 (final data collection date for primary outcome measure) | ||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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| Gender | Both | ||||
| Ages | 12 Years to 80 Years | ||||
| Accepts Healthy Volunteers | No | ||||
| Contacts ICMJE |
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| Location Countries ICMJE | Taiwan | ||||
| Administrative Information | |||||
| NCT Number ICMJE | NCT00677989 | ||||
| Other Study ID Numbers ICMJE | FEMH No. 96044 | ||||
| Has Data Monitoring Committee | No | ||||
| Responsible Party | Heng-Fu Lin, chief of the tramatology division, surgical department, Traumatology Department,Far-Eastern Memorial Hospital, Taipei , Taiwan | ||||
| Study Sponsor ICMJE | Far Eastern Memorial Hospital | ||||
| Collaborators ICMJE | Not Provided | ||||
| Investigators ICMJE |
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| Information Provided By | Far Eastern Memorial Hospital | ||||
| Verification Date | January 2009 | ||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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