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

NCT ID: NCT02714023

Last Updated: 2018-10-15

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 241 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2012-10-10
• Study Completion Date: 2017-11-29

Brief Summary

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

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.

Conditions

Acute Appendicitis; Abscess

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

Normal Saline

Patients were randomized to receive normal saline as an irrigation solution during appendectomy.

Group Type: ACTIVE_COMPARATOR

Normal Saline

Intervention Type: PROCEDURE

Intra-operative irrigation with normal saline

Sterile Water

Patients were randomized to receive sterile water as an irrigation solution during appendectomy.

Group Type: ACTIVE_COMPARATOR

Sterile Water

Intervention Type: PROCEDURE

Intra-operative irrigation with sterile water

No irrigation used

Patients who do not receive any irrigation at time of operation.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Normal Saline

Intra-operative irrigation with normal saline

Intervention Type: PROCEDURE

Sterile Water

Intra-operative irrigation with sterile water

Intervention Type: PROCEDURE

Eligibility Criteria

Exclusion Criteria

• Pregnant patients, patients with mental handicap, Veterans, patients under 6 years old

• Minimum Eligible Age: 6 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

University of Missouri-Columbia

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Arthur Rawlings, MD

Role: PRINCIPAL_INVESTIGATOR

University of Missouri-Columbia

Locations

University of Missouri

Columbia, Missouri, United States

Countries

United States

References

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Other Identifiers

1201672

Identifier Type: -

Identifier Source: org_study_id