Irrigation Versus No Irrigation for Perforated Appendicitis - NCT00854815-64108 (Clinical Trial 275483)
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| City: |
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Kansas City |
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State:
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MO |
| Zip Code: |
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64108 |
| Conditions: |
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Perforated Appendicitis |
| Purpose: |
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The purpose is to quantify the effect of irrigation during laparoscopic appendectomy for
perforated appendicitis.
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| Study summary: |
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This will be a prospective, randomized clinical trial involving patients who present to the
hospital with perforated appendicitis. This will be a definitive study.
Power calculation was based on abscess rate in the previous prospective study. An
unacceptable abscess rate needed to be chosen. Our current rate is 20%, or one-fifth of the
patients. If this were to increase by 15%, it would place just over one third of the
patients at risk which would be unacceptable. This is comparable to the 36% rejection level
we used for the previous IRB approved trial (#07 02-031). Using a delta of 0.15 with alpha
of 0.05 and power of 0.8, the sample size is 109 patients in each arm. Therefore we will
anticipate enrolling 220.
Subjects will be those children who are found to have severe inflammatory changes on imaging
or a high clinical suspicion of perforation. Permission will be obtained from parents prior
to the operation. All of these children will be under duress prior to randomization,
therefore we request waiving assent as we have done with the previous perforated
appendicitis studies.
The final decision to include a child in the study will made after perforation has been
visually confirmed during surgery. Perforation will be defined as an identifiable hole in
the appendix or stool in the abdomen. The randomization assignment will be made known at the
initiation of the operation, and confirmation of perforation will confirm the patient will
utilize the next randomization slot.
The irrigation group will have suction irrigator set up with a 1 liter bag of normal saline.
The surgeon must use at least 500 ml of this bag but may use as much as they choose.
The no irrigation group will have the suction irrigator set up without the saline
attachment. This will leave them with the capacity for suction only. Since several suction
devices exist, this will assure the same type of suction for both groups.
After the operation, both groups will be managed in the same manner. When the patient is
tolerating a regular diet, on oral pain medication and has been afebrile for over 12 hours,
they will be discharged on oral antibiotics to complete a course of 7 days. If they stay
until the 5th post-operative day, a white blood cell count will be checked, which if it is
normal, they will be discharged to home without antibiotics. This is standard
post-operative care as delineate by our previous prospective, randomized. |
| Criteria: |
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Inclusion Criteria:
- Under 18 yrs old
- Perforation identified as hole in the appendix or fecalith in the abdomen
Exclusion Criteria:
- No perforation
- A significant comorbidity that would limit their ability to recover from appendectomy
in a normal fashion |
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| Study is available at: |
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Children's Mercy Hospital
Kansas City, MO 64108
United States
Primary Contact:
Shawn D St. Peter, MD
Email: sspeter@cmh.edu
Phone: 816-983-6579
Secondary Contact:
Shawn D St. Peter, MD
Email: sspeter@cmh.edu
Phone: 816 983 6479 |
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If you are interested in this clinical trial please use the contact information above. If you would like to get additional information about this clinical trial please visit ClinicalTrials.gov.
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| Data Source: |
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ClinicalTrials.gov |
| Date Processed: |
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March 16, 2010 |
Modifications to
this listing: |
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Only selected fields are shown, please use the link
above to view all information about this clinical trial. |
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Clinical trials are medical research studies designed to test the safety and/or
effectiveness of new drugs, devices, or treatments in humans. These studies are
conducted worldwide for a range of conditions and illnesses. Learn more about
clinical research and participating in a study at
About Clinical Trials.
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