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

Acute Appendicitis Clinical Trial

— WASHITBEST  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02714023
• Other study ID #: 1201672
• Status: Completed
• Phase: N/A
• Start date: October 10, 2012
• Est. completion date: November 29, 2017

Study information

• Verified date: October 2018
• Source: University of Missouri-Columbia
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 241
• Est. completion date: November 29, 2017
• Est. primary completion date: September 10, 2015
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 6 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Abscess
• Acute Appendicitis
• Appendicitis

Intervention

Procedure:
• Normal Saline
Intra-operative irrigation with normal saline
• Sterile Water
Intra-operative irrigation with sterile water

Locations

Country	Name	City	State
United States	University of Missouri	Columbia	Missouri

Sponsors (1)

Lead Sponsor	Collaborator
University of Missouri-Columbia

Country where clinical trial is conducted

United States, 

References & Publications (17)

Addiss DG, Shaffer N, Fowler BS, Tauxe RV. The epidemiology of appendicitis and appendectomy in the United States. Am J Epidemiol. 1990 Nov;132(5):910-25. — View Citation

Andersen BR, Kallehave FL, Andersen HK. Antibiotics versus placebo for prevention of postoperative infection after appendicectomy. Cochrane Database Syst Rev. 2005 Jul 20;(3):CD001439. Review. — View Citation

Bonanni F, Reed J 3rd, Hartzell G, Trostle D, Boorse R, Gittleman M, Cole A. Laparoscopic versus conventional appendectomy. J Am Coll Surg. 1994 Sep;179(3):273-8. — View Citation

Cheng Y, Zhou S, Zhou R, Lu J, Wu S, Xiong X, Ye H, Lin Y, Wu T, Cheng N. Abdominal drainage to prevent intra-peritoneal abscess after open appendectomy for complicated appendicitis. Cochrane Database Syst Rev. 2015 Feb 7;(2):CD010168. doi: 10.1002/14651858.CD010168.pub2. Review. Update in: Cochrane Database Syst Rev. 2018 May 09;5:CD010168. — View Citation

Fernandez R, Griffiths R. Water for wound cleansing. Cochrane Database Syst Rev. 2012 Feb 15;(2):CD003861. doi: 10.1002/14651858.CD003861.pub3. Review. — View Citation

Guller U, Hervey S, Purves H, Muhlbaier LH, Peterson ED, Eubanks S, Pietrobon R. Laparoscopic versus open appendectomy: outcomes comparison based on a large administrative database. Ann Surg. 2004 Jan;239(1):43-52. — View Citation

Hughes MJ, Harrison E, Paterson-Brown S. Post-operative antibiotics after appendectomy and post-operative abscess development: a retrospective analysis. Surg Infect (Larchmt). 2013 Feb;14(1):56-61. doi: 10.1089/sur.2011.100. Epub 2013 Feb 21. — View Citation

Ingraham AM, Cohen ME, Bilimoria KY, Pritts TA, Ko CY, Esposito TJ. Comparison of outcomes after laparoscopic versus open appendectomy for acute appendicitis at 222 ACS NSQIP hospitals. Surgery. 2010 Oct;148(4):625-35; discussion 635-7. doi: 10.1016/j.surg.2010.07.025. Epub 2010 Aug 24. — View Citation

Krisher SL, Browne A, Dibbins A, Tkacz N, Curci M. Intra-abdominal abscess after laparoscopic appendectomy for perforated appendicitis. Arch Surg. 2001 Apr;136(4):438-41. — View Citation

Moore CB, Smith RS, Herbertson R, Toevs C. Does use of intraoperative irrigation with open or laparoscopic appendectomy reduce post-operative intra-abdominal abscess? Am Surg. 2011 Jan;77(1):78-80. — View Citation

Paik PS, Towson JA, Anthone GJ, Ortega AE, Simons AJ, Beart RW Jr. Intra-abdominal abscesses following laparoscopic and open appendectomies. J Gastrointest Surg. 1997 Mar-Apr;1(2):188-92; discussion 192-3. — View Citation

Parcells JP, Mileski JP, Gnagy FT, Haragan AF, Mileski WJ. Using antimicrobial solution for irrigation in appendicitis to lower surgical site infection rates. Am J Surg. 2009 Dec;198(6):875-80. doi: 10.1016/j.amjsurg.2009.09.002. — View Citation

Shuler FW, Newman CN, Angood PB, Tucker JG, Lucas GW. Nonoperative management for intra-abdominal abscesses. Am Surg. 1996 Mar;62(3):218-22. — View Citation

Solomkin JS, Mazuski JE, Bradley JS, Rodvold KA, Goldstein EJ, Baron EJ, O'Neill PJ, Chow AW, Dellinger EP, Eachempati SR, Gorbach S, Hilfiker M, May AK, Nathens AB, Sawyer RG, Bartlett JG. Diagnosis and management of complicated intra-abdominal infection in adults and children: guidelines by the Surgical Infection Society and the Infectious Diseases Society of America. Surg Infect (Larchmt). 2010 Feb;11(1):79-109. doi: 10.1089/sur.2009.9930. — View Citation

Tzovaras G, Baloyiannis I, Kouritas V, Symeonidis D, Spyridakis M, Poultsidi A, Tepetes K, Zacharoulis D. Laparoscopic versus open appendectomy in men: a prospective randomized trial. Surg Endosc. 2010 Dec;24(12):2987-92. doi: 10.1007/s00464-010-1160-5. Epub 2010 Jun 15. — View Citation

van Rossem CC, Schreinemacher MH, Treskes K, van Hogezand RM, van Geloven AA. Duration of antibiotic treatment after appendicectomy for acute complicated appendicitis. Br J Surg. 2014 May;101(6):715-9. doi: 10.1002/bjs.9481. Epub 2014 Mar 26. — View Citation

Ward NT, Ramamoorthy SL, Chang DC, Parsons JK. Laparoscopic appendectomy is safer than open appendectomy in an elderly population. JSLS. 2014 Jul-Sep;18(3). pii: e2014.00322. doi: 10.4293/JSLS.2014.00322. — View Citation

* Note: There are 17 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Post-operative deep space organ infection as defined by the Surgical Infection Society	Infection after surgery within the peritoneal space	30 days
Secondary	Temperature greater than 38.5 degree Celsius	Chart review for evidence of prolonged fever >38.5 for >2 days	30 days
Secondary	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
Secondary	Length of Hospital Stay	Medical record will be reviewed for hospital length of stay following surgery	30 days