Irrigation Versus No Irrigation for Perforated Appendicitis

Status Completed

Clinical Trial Summary

The purpose is to quantify the effect of irrigation during laparoscopic appendectomy for perforated appendicitis.

Clinical Trial Description

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 delineated by our previous prospective, randomized. ;

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT00854815
Study type	Interventional
Source	Children's Mercy Hospital Kansas City
Contact
Status	Completed
Phase	N/A
Start date	December 2008
Completion date	June 2012

View Details

See also
Status	Clinical Trial	Phase
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Completed	`NCT00528138` - Hyperbilirubinemia in Acute Appendicitis as a Predictor of Perforation	N/A
Completed	`NCT03289351` - Two Different Antibiotics Versus One Antibiotic for Pediatric Perforated Appendicitis	Phase 4
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Completed	`NCT00677417` - Diagnostic Value of Hyperbilirubinaemia as a Predictive Factor for Appendiceal Perforation in Acute Appendicitis	N/A
Terminated	`NCT00540189` - Initial Versus Delayed Operation for Treatment of Complicated Appendicitis In Children	N/A
Terminated	`NCT03795194` - Antibiotic Duration in Post-appendectomy Abscess	Phase 4
Completed	`NCT00462020` - Intravenous Versus Intravenous/Oral Antibiotics for Perforated Appendicitis	N/A
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Completed	`NCT02881996` - The Impact of IV Acetaminophen on Pain After Appendectomy for Perforated Appendicitis	N/A
Active, not recruiting	`NCT04039750` - Use of Antibiotic Irrigation to Decrease Wound Infections in Pediatric Perforated Appendicitis	Phase 2
Completed	`NCT02724410` - Role of Intravenous Versus Home Oral Antibiotics in Perforated Appendicitis	N/A
Recruiting	`NCT04253899` - The Management of Perforated Acute Appendicitis in Adult and Pediatric Populations	N/A
Completed	`NCT00195923` - Prospective Randomized Evaluation of Antibiotic Regimen Following Appendectomy for Perforated Appendicitis	Phase 4
Withdrawn	`NCT00879294` - The Effect of Gum Chewing on Postoperative Ileus	N/A

Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.