NCT02714023

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
241

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Oct 2012

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 10, 2012

Completed
2.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 10, 2015

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

March 8, 2016

Completed
13 days until next milestone

First Posted

Study publicly available on registry

March 21, 2016

Completed
1.7 years until next milestone

Study Completion

Last participant's last visit for all outcomes

November 29, 2017

Completed
Last Updated

October 15, 2018

Status Verified

October 1, 2018

Enrollment Period

2.9 years

First QC Date

March 8, 2016

Last Update Submit

October 10, 2018

Conditions

Acute AppendicitisAbscess

Outcome Measures

Primary Outcomes (1)

  • Post-operative deep space organ infection as defined by the Surgical Infection Society

    Infection after surgery within the peritoneal space

    30 days

Secondary Outcomes (3)

  • Temperature greater than 38.5 degree Celsius

    30 days

  • Greater than 2 days to return of bowel function as evident by either flatus or bowel movement

    30 days

  • Length of Hospital Stay

    30 days

Study Arms (3)

Normal Saline

ACTIVE COMPARATOR

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

Procedure: Normal Saline

Sterile Water

ACTIVE COMPARATOR

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

Procedure: Sterile Water

No irrigation used

NO INTERVENTION

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

Interventions

Normal SalinePROCEDURE

Intra-operative irrigation with normal saline

Normal Saline
Sterile WaterPROCEDURE

Intra-operative irrigation with sterile water

Sterile Water

Eligibility Criteria

Age6 Years+
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Missouri

Columbia, Missouri, 65212, United States

Location

Related Publications (17)

  • 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.

    PMID: 21396311BACKGROUND

  • 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.

    PMID: 23427791BACKGROUND

  • 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.

    PMID: 8069421BACKGROUND

  • 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. doi: 10.1016/s1091-255x(97)80108-4.

    PMID: 9834347BACKGROUND

  • 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. doi: 10.1001/archsurg.136.4.438.

    PMID: 11296116BACKGROUND

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

    PMID: 8607582BACKGROUND

  • 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.

    PMID: 20163262BACKGROUND

  • 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.

    PMID: 20797745BACKGROUND

  • 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.

    PMID: 20552369BACKGROUND

  • 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. doi: 10.1097/01.sla.0000103071.35986.c1.

    PMID: 14685099BACKGROUND

  • 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):e2014.00322. doi: 10.4293/JSLS.2014.00322.

    PMID: 25392668BACKGROUND

  • Andersen BR, Kallehave FL, Andersen HK. Antibiotics versus placebo for prevention of postoperative infection after appendicectomy. Cochrane Database Syst Rev. 2005 Jul 20;2005(3):CD001439. doi: 10.1002/14651858.CD001439.pub2.

    PMID: 16034862BACKGROUND

  • 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.

    PMID: 24668341BACKGROUND

  • 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.

    PMID: 25914903BACKGROUND

  • 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.

    PMID: 19969145BACKGROUND

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

    PMID: 22336796BACKGROUND

  • 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. doi: 10.1093/oxfordjournals.aje.a115734.

    PMID: 2239906RESULT

MeSH Terms

Conditions

AppendicitisAbscess

Interventions

Saline Solution

Condition Hierarchy (Ancestors)

Intraabdominal InfectionsInfectionsGastroenteritisGastrointestinal DiseasesDigestive System DiseasesCecal DiseasesIntestinal DiseasesSuppurationInflammationPathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Crystalloid SolutionsIsotonic SolutionsSolutionsPharmaceutical Preparations

Study Officials

  • Arthur Rawlings, MD

    University of Missouri-Columbia

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 8, 2016

First Posted

March 21, 2016

Study Start

October 10, 2012

Primary Completion

September 10, 2015

Study Completion

November 29, 2017

Last Updated

October 15, 2018

Record last verified: 2018-10

Data Sharing

IPD Sharing
Will not share

Locations

US(1)