Hypothesis: The purpose of this study is to quantify the complications, both by type and number, following operation for NEC and evaluate the data to elicit high-risk patient subsets.
Specific Aims :
The specific aims of this study are as follows: 1. Accurately record, in a prospective fashion, all cases of NEC that require surgical intervention, the outcome and any complications, 2. Quantify the complications, 3. Evaluate the data to find patient subsets at high risk for complications, 4. Evaluate the data to find procedure types that result in a high number of complications, 5. Formulate recommendations for surgical therapy of NEC. Background: Necrotizing enterocolitis continues to be a significant contributor of morbidity and mortality in the premature infant population. The primary treatment for the entity remains surgical; however, the complications of the surgery itself have not yet been quantified in a prospective fashion. Retrospective data reveals a fairly high complication rate following operation for NEC. These complications include sepsis, stricture, short gut, wound infections, bowel obstructions, and abscesses. Therefore, any means to quantify the complications following operation for NEC may assist in determining patient subsets or operative procedures which lead to elevated morbidity or mortality and allow modification of treatment to these high risk groups. Methods: Treatment will not be modified for patients enrolled in the study. Surgeries will be performed on the involved patient in accordance with the attending physician's judgement. Information regarding preoperative antibiotics, radiographic evaluation and findings, preoperative laboratories, operation performed, intraoperative findings, type of closure, pathology, culture results, nutritional data and associated procedures and complications will be recorded. Patients will then be followed postoperatively for surgical complications. Data from additional surgeries required by the patient will be recorded in the same fashion and the patient will again be followed for the development of any postoperative complication. Patients will be kept on the study until the endpoints of death or discharge from the hospital. The primary and intensive care teams that would normally be involved in the patient's care will follow patients. Patients will be examined on a daily basis for signs of sepsis, wound infection/breakdown/dehiscence, stoma complication, fistula or other possible postoperative complications. The investigator will be alerted to any potential complication(s).

Project Start
1999-12-01
Project End
2001-02-28
Budget Start
1998-10-01
Budget End
1999-09-30
Support Year
15
Fiscal Year
2000
Total Cost
$11,128
Indirect Cost
City
Houston
State
TX
Country
United States
Zip Code
77225
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