Irrigation Versus No Irrigation for Perforated Appendicitis
Condition: Perforated Appendicitis
MeSH terms: Appendicitis
Study type: Interventional

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

Detailed 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.
    

Intervention name(s): Irrigation; No Irrigation
Intervention type(s): Procedure; Procedure
Intervention description(s): Irrigation of the area with at least 500ml NS using the power suction/irrigator; Suction only using suction/irrigator
Other intervention name(s): washout; suction
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Perforated appendicitis; laparoscopic appendectomy; children; irrigation