Irrigation Versus No Irrigation for Perforated Appendicitis

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Shawn St. Peter, Children's Mercy Hospital Kansas City
ClinicalTrials.gov Identifier:
NCT00854815
First received: March 2, 2009
Last updated: July 31, 2012
Last verified: July 2012
  Purpose

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


Condition Intervention
Perforated Appendicitis
Procedure: Irrigation
Procedure: No Irrigation

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Irrigation Versus No Irrigation for Perforated Appendicitis

Resource links provided by NLM:


Further study details as provided by Children's Mercy Hospital Kansas City:

Primary Outcome Measures:
  • Post-operative abscess [ Time Frame: 1 month ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • operating time [ Time Frame: 1 day ] [ Designated as safety issue: No ]
  • length of stay [ Time Frame: 2 weeks ] [ Designated as safety issue: No ]

Estimated Enrollment: 220
Study Start Date: December 2008
Study Completion Date: June 2012
Primary Completion Date: June 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Irrigation
Irrigation of the area with at least 500ml normal saline using the power suction/irrigator
Procedure: Irrigation
Irrigation of the area with at least 500ml NS using the power suction/irrigator
Other Name: washout
Active Comparator: No Irrigation
Only suction with the power suction/irrigator without saline attached
Procedure: No Irrigation
Suction only using suction/irrigator
Other Name: suction

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.

  Eligibility

Ages Eligible for Study:   1 Month to 17 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00854815

Locations
United States, Missouri
Children's Mercy Hospital
Kansas City, Missouri, United States, 64108
Sponsors and Collaborators
Children's Mercy Hospital Kansas City
Investigators
Principal Investigator: Shawn D St. Peter, MD Children's Mercy Hospital Kansas City
  More Information

No publications provided

Responsible Party: Shawn St. Peter, MD, Children's Mercy Hospital Kansas City
ClinicalTrials.gov Identifier: NCT00854815     History of Changes
Other Study ID Numbers: 08 11 181
Study First Received: March 2, 2009
Last Updated: July 31, 2012
Health Authority: United States: Institutional Review Board

Keywords provided by Children's Mercy Hospital Kansas City:
Perforated appendicitis
laparoscopic appendectomy
children
irrigation

Additional relevant MeSH terms:
Appendicitis
Acute Disease
Intraabdominal Infections
Infection
Gastroenteritis
Gastrointestinal Diseases
Digestive System Diseases
Cecal Diseases
Intestinal Diseases
Disease Attributes
Pathologic Processes

ClinicalTrials.gov processed this record on September 18, 2014