Water And Saline Head-to-head In The Blinded Evaluation Study Trial

Study Overview
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Brief Summary
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Patients who are diagnosed with acute appendicitis consented and then randomized into two arms of the trial. In one arm, patients receive irrigation of the abdomen during surgery with normal saline, or salt water. In the other arm, patients receive irrigation of the abdomen during surgery with sterile water. Sometimes patients receive no irrigation if none is determined to be needed at the time of operation by the surgeon. We then followed patients after surgery for 30 days. The hypothesis of this study was that the use of sterile water as irrigation fluid during surgery in patients who have acute appendicitis will decrease the chance of a post-operative abscess or infection.

Detailed Description
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All patients, aged 6 and above, who present for an emergent or interval appendectomy to any one of the participating surgeons will potentially be enrolled in the study. Prior to surgery, the patient or the patient's guardian if a minor, will be informed of the study and consent (assent of minors will be obtained) will be requested. If consent is obtained, the patient's name and medical record number will then be sent to the inpatient pharmacy. They will be randomly assigned using a master list to either water or saline arm. The pharmacy will then send the correct solution to the operating room in the form of 3 one Liter bags. This will be ordered prior to going to the operating room. Next, a laparoscopic or open appendectomy will be performed according to the current standard of care. The surgeon will also be free to convert a laparoscopic procedure to an open procedure if deemed appropriate by his or her clinical judgment. The type of irrigant used during the case, however, will be blinded to the surgeon. The surgeon will use as much irrigation solution as they deem necessary based on an intra-operative decision. This will likely not have any affect on the study, as there is no standard amount of irrigation that is needed during appendectomies, and we do not wish to change the current practices of our surgeons. Additionally, the study question of if sterile water will decrease infectious rates will not be affected either. The science of this study will remain the same whether 10 mL or 3000 mL of irrigation solution is utilized. The surgeon may use more irrigation if deemed necessary to adequately wash the abdomen and remove all particulate matter and blood clots. At the end of the case, the surgeon will record the amount of irrigant used along with surgery date, duration of symptoms, surgery start and finish time, preoperative antibiotics, height and weight. The patient will be followed in the study for 30 days after surgery. There is usually a follow up office visit one to two weeks after the procedure. A chart review after the case will capture the length of stay, post-operative antibiotic, pathology report results, and complications consisting such as prolonged ileus (>2 days), bowel obstruction, prolonged fever (> 2 days), post-operative abscess, irrigation volume, and wound infection.

Official Title
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Water And Saline Head-to-head In The Blinded Evaluation Study Trial

Conditions
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Acute Appendicitis, Abscess

Intervention / Treatment
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* Procedure: Normal Saline
* Procedure: Sterile Water


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: All patients, age 6 and older, who present for an emergent or interval appendectomy to any one of the participating surgeons, meet the inclusion criteria for the study. Assent from all minors (under age 18) was obtained. Exclusion Criteria: Pregnant patients, patients with mental handicap, Veterans, patients under 6 years old

Ages Eligible for Study
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Minimum Age: 6 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Normal Saline<br>Patients were randomized to receive normal saline as an irrigation solution during appendectomy. | Procedure: Normal Saline<br>* Intra-operative irrigation with normal saline<br>|
| Active Comparator: Sterile Water<br>Patients were randomized to receive sterile water as an irrigation solution during appendectomy. | Procedure: Sterile Water<br>* Intra-operative irrigation with sterile water<br>|
| No Intervention: No irrigation used<br>Patients who do not receive any irrigation at time of operation. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Post-operative deep space organ infection as defined by the Surgical Infection Society | Infection after surgery within the peritoneal space | 30 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Temperature greater than 38.5 degree Celsius | Chart review for evidence of prolonged fever >38.5 for >2 days | 30 days | 
| Greater than 2 days to return of bowel function as evident by either flatus or bowel movement | Chart review for evidence of prolonged ileus for >2days | 30 days | 
| Length of Hospital Stay | Medical record will be reviewed for hospital length of stay following surgery | 30 days |