NCT03723642

Brief Summary

In the planned prospective randomized study, oxidative stress will be investigated by analyzing volatile organic compounds in the exhaled air in children. Children who have undergone open versus laparoscopic surgery for appendicitis will be compared. A better understanding of the effects of the surgical technique could be a prerequisite for an optimized surgical setting. It could also lead to recommendations for pre- or perioperatively antioxidative agents.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
40

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Oct 2019

Geographic Reach
1 country

1 active site

Status
unknown

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

First Submitted

Initial submission to the registry

July 10, 2018

Completed
4 months until next milestone

First Posted

Study publicly available on registry

October 29, 2018

Completed
11 months until next milestone

Study Start

First participant enrolled

October 2, 2019

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2020

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2020

Completed
Last Updated

July 15, 2020

Status Verified

July 1, 2020

Enrollment Period

1 year

First QC Date

July 10, 2018

Last Update Submit

July 13, 2020

Conditions

Appendicitis Acute

Keywords

acute appendicitisvolatile organic compoundsoxidative stresslaparoscopic appendectomyopen appendectomy

Outcome Measures

Primary Outcomes (1)

  • Are volatile respiratory gas markers for oxidative stress (such as pentanes, isoprenes) dependent on the surgical method (open versus laparoscopic appendectomy)?

    We investigate the respiratory volatile organic compounds before, during and at the end of surgery and compare the respiratory gas profiles of the two groups open versus laparoscopic appendectomy.

    1 year

Secondary Outcomes (2)

  • Alterations of serum malondialdehyde serum levels.

    1 year

  • Alterations of inflammation markers.

    1 year

Study Arms (2)

OAE group

ACTIVE COMPARATOR

All patients will undergo measurements of oxydative stress (initial serum malondialdehyde level and final serum malondialdehyde level), White blood cell count (initial differential white blood cell count and final differential white blood cell count), c-reactive protein measurements (initial c-reactive protein serum level and final c-reactive protein serum level) as well as volatile organic compound (VOC) sampling (initial VOC, VOC 5min, VOC 15min, VOC 30min, VOC 45min and final VOC).

Diagnostic Test: Initial serum malondialdehyde levelDiagnostic Test: Final serum malondialdehyde levelDiagnostic Test: Initial differential white blood cell countDiagnostic Test: Final differential white blood cell countDiagnostic Test: Initial c-reactive protein serum levelDiagnostic Test: Final c-reactive protein serum levelDiagnostic Test: Initial VOCDiagnostic Test: VOC 5minDiagnostic Test: VOC 15minDiagnostic Test: VOC 30minDiagnostic Test: VOC 45minDiagnostic Test: Final VOC

LAE group

ACTIVE COMPARATOR

All patients will undergo measurements of oxydative stress (initial serum malondialdehyde level and final serum malondialdehyde level), White blood cell count (initial differential white blood cell count and final differential white blood cell count), c-reactive protein measurements (initial c-reactive protein serum level and final c-reactive protein serum level) as well as volatile organic compound (VOC) sampling (initial VOC, VOC 5min, VOC 15min, VOC 30min, VOC 45min and final VOC).

Diagnostic Test: Initial serum malondialdehyde levelDiagnostic Test: Final serum malondialdehyde levelDiagnostic Test: Initial differential white blood cell countDiagnostic Test: Final differential white blood cell countDiagnostic Test: Initial c-reactive protein serum levelDiagnostic Test: Final c-reactive protein serum levelDiagnostic Test: Initial VOCDiagnostic Test: VOC 5minDiagnostic Test: VOC 15minDiagnostic Test: VOC 30minDiagnostic Test: VOC 45minDiagnostic Test: Final VOC

Interventions

Initial serum malondialdehyde levelDIAGNOSTIC_TEST

Blood sample (0.4ml) will be obtained within 5 minutes before induction of general anaesthesia. Samples will be obtained in both groups (LAE and OAE)

LAE groupOAE group
Final serum malondialdehyde levelDIAGNOSTIC_TEST

Blood sample (0.4ml) will be obtained within 5 minutes after wound closure. Samples will be obtained in both groups (LAE and OAE)

LAE groupOAE group
Initial differential white blood cell countDIAGNOSTIC_TEST

Differential blood counts (microscopic) will be obtained during pre-operative routine work-up. Samples will be obtained in both groups (LAE and OAE).

LAE groupOAE group
Final differential white blood cell countDIAGNOSTIC_TEST

Differential blood counts (microscopic) will be obtained 24h after the first sample (Initial differential blood count). Samples will be obtained in both groups (LAE and OAE).

LAE groupOAE group
Initial c-reactive protein serum levelDIAGNOSTIC_TEST

C-reactive protein levels will be obtained during pre-operative routine work-up. Samples will be obtained in both groups (LAE and OAE).

LAE groupOAE group
Final c-reactive protein serum levelDIAGNOSTIC_TEST

C-reactive protein levels will be obtained 24h after the first sample (initial c-reactive protein level). Samples will be obtained in both groups (LAE and OAE).

LAE groupOAE group
Initial VOCDIAGNOSTIC_TEST

Volatile organic compound sampling (2 samples within 5 minutes) within 10 minutes before induction of general anesthesia

LAE groupOAE group
VOC 5minDIAGNOSTIC_TEST

Volatile organic compound sampling (2 samples within5 minutes) within 5 minutes after endotracheal intubation before skin incision.

LAE groupOAE group
VOC 15minDIAGNOSTIC_TEST

Volatile organic compound sampling (2 samples within 5 minutes) 15 minutes after skin incision.

LAE groupOAE group
VOC 30minDIAGNOSTIC_TEST

Volatile organic compound sampling (2 samples within 5 minutes) 30 minutes after skin incision.

LAE groupOAE group
VOC 45minDIAGNOSTIC_TEST

Volatile organic compound sampling (2 samples within 5 minutes) 45 minutes after skin incision.

LAE groupOAE group
Final VOCDIAGNOSTIC_TEST

Volatile organic compound sampling (2 samples within 5 minutes) within 5 minutes after skin closure.

LAE groupOAE group

Eligibility Criteria

Age6 Years - 18 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • Age from 6-18 years
  • reliable diagnosis of acute appendicitis
  • surgical therapy using open/laparoscopic surgical technique
  • given approval

You may not qualify if:

  • Age not between 6 and 18 years
  • chronic underlying disease/autoimmune disease
  • complicated appendicitis (perforation, consecutive purulent peritonitis, abscess formation)
  • infection outside acute appendicitis
  • SIRS
  • taking medications containing the cytochrome P450 (CYP) system affect including cortisone
  • impaired liver function
  • unaccepted consent

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of Paediatric and Adolescent Surgery

Graz, 8036, Austria

RECRUITING

Related Publications (27)

  • Stringer MD. Acute appendicitis. J Paediatr Child Health. 2017 Nov;53(11):1071-1076. doi: 10.1111/jpc.13737. Epub 2017 Oct 17.

    PMID: 29044790BACKGROUND

  • Ohmann C, Franke C, Kraemer M, Yang Q. [Status report on epidemiology of acute appendicitis]. Chirurg. 2002 Aug;73(8):769-76. doi: 10.1007/s00104-002-0512-7. German.

    PMID: 12425152BACKGROUND

  • Gorter RR, Eker HH, Gorter-Stam MA, Abis GS, Acharya A, Ankersmit M, Antoniou SA, Arolfo S, Babic B, Boni L, Bruntink M, van Dam DA, Defoort B, Deijen CL, DeLacy FB, Go PM, Harmsen AM, van den Helder RS, Iordache F, Ket JC, Muysoms FE, Ozmen MM, Papoulas M, Rhodes M, Straatman J, Tenhagen M, Turrado V, Vereczkei A, Vilallonga R, Deelder JD, Bonjer J. Diagnosis and management of acute appendicitis. EAES consensus development conference 2015. Surg Endosc. 2016 Nov;30(11):4668-4690. doi: 10.1007/s00464-016-5245-7. Epub 2016 Sep 22.

    PMID: 27660247BACKGROUND

  • Binnebosel M, Otto J, Stumpf M, Mahnken AH, Gassler N, Schumpelick V, Truong S. [Acute appendicitis. Modern diagnostics--surgical ultrasound]. Chirurg. 2009 Jul;80(7):579-87. doi: 10.1007/s00104-009-1684-1. German.

    PMID: 19471900BACKGROUND

  • Kim M, Kim SJ, Cho HJ. International normalized ratio and serum C-reactive protein are feasible markers to predict complicated appendicitis. World J Emerg Surg. 2016 Jun 21;11:31. doi: 10.1186/s13017-016-0081-6. eCollection 2016.

    PMID: 27330547BACKGROUND

  • Svensson JF, Hall NJ, Eaton S, Pierro A, Wester T. A review of conservative treatment of acute appendicitis. Eur J Pediatr Surg. 2012 Jun;22(3):185-94. doi: 10.1055/s-0032-1320014. Epub 2012 Jul 5.

    PMID: 22767171BACKGROUND

  • Blakely ML, Williams R, Dassinger MS, Eubanks JW 3rd, Fischer P, Huang EY, Paton E, Culbreath B, Hester A, Streck C, Hixson SD, Langham MR Jr. Early vs interval appendectomy for children with perforated appendicitis. Arch Surg. 2011 Jun;146(6):660-5. doi: 10.1001/archsurg.2011.6. Epub 2011 Feb 21.

    PMID: 21339413BACKGROUND

  • Whyte C, Levin T, Harris BH. Early decisions in perforated appendicitis in children: lessons from a study of nonoperative management. J Pediatr Surg. 2008 Aug;43(8):1459-63. doi: 10.1016/j.jpedsurg.2007.11.032.

    PMID: 18675635BACKGROUND

  • Li X, Zhang J, Sang L, Zhang W, Chu Z, Li X, Liu Y. Laparoscopic versus conventional appendectomy--a meta-analysis of randomized controlled trials. BMC Gastroenterol. 2010 Nov 3;10:129. doi: 10.1186/1471-230X-10-129.

    PMID: 21047410BACKGROUND

  • Coccolini F, Trana C, Sartelli M, Catena F, Di Saverio S, Manfredi R, Montori G, Ceresoli M, Falcone C, Ansaloni L. Laparoscopic management of intra-abdominal infections: Systematic review of the literature. World J Gastrointest Surg. 2015 Aug 27;7(8):160-9. doi: 10.4240/wjgs.v7.i8.160.

    PMID: 26328036BACKGROUND

  • Ciftci F. Laparoscopic vs mini-incision open appendectomy. World J Gastrointest Surg. 2015 Oct 27;7(10):267-72. doi: 10.4240/wjgs.v7.i10.267.

    PMID: 26525039BACKGROUND

  • Noviello C, Romano M, Martino A, Cobellis G. Transumbilical Laparoscopic-Assisted Appendectomy in the Treatment of Acute Uncomplicated Appendicitis in Children. Gastroenterol Res Pract. 2015;2015:949162. doi: 10.1155/2015/949162. Epub 2015 Sep 29.

    PMID: 26491433BACKGROUND

  • Khan SY, Al-Balushi ZN, Bhatti KM, Ehsan T, Mandhan P. Cost Comparison between Laparoscopic and Open Appendectomies in Children. Sultan Qaboos Univ Med J. 2013 May;13(2):275-9. doi: 10.12816/0003234. Epub 2013 May 9.

    PMID: 23862034BACKGROUND

  • Zelzer S, Oberreither R, Bernecker C, Stelzer I, Truschnig-Wilders M, Fauler G. Measurement of total and free malondialdehyde by gas-chromatography mass spectrometry--comparison with high-performance liquid chromatography methology. Free Radic Res. 2013 Aug;47(8):651-6. doi: 10.3109/10715762.2013.812205. Epub 2013 Jul 2.

    PMID: 23745592BACKGROUND

  • McCrum-Gardner E. Which is the correct statistical test to use? Br J Oral Maxillofac Surg. 2008 Jan;46(1):38-41. doi: 10.1016/j.bjoms.2007.09.002. Epub 2007 Oct 24.

    PMID: 17961892BACKGROUND

  • Kapischke M, Pries A, Caliebe A. Short term and long term results after open vs. laparoscopic appendectomy in childhood and adolescence: a subgroup analysis. BMC Pediatr. 2013 Oct 1;13:154. doi: 10.1186/1471-2431-13-154.

    PMID: 24079822RESULT

  • Jaschinski T, Mosch C, Eikermann M, Neugebauer EA. Laparoscopic versus open appendectomy in patients with suspected appendicitis: a systematic review of meta-analyses of randomised controlled trials. BMC Gastroenterol. 2015 Apr 15;15:48. doi: 10.1186/s12876-015-0277-3.

    PMID: 25884671RESULT

  • Minutolo V, Licciardello A, Di Stefano B, Arena M, Arena G, Antonacci V. Outcomes and cost analysis of laparoscopic versus open appendectomy for treatment of acute appendicitis: 4-years experience in a district hospital. BMC Surg. 2014 Mar 19;14:14. doi: 10.1186/1471-2482-14-14.

    PMID: 24646120RESULT

  • Tsai CC, Lee SY, Huang FC. Laparoscopic versus open appendectomy in the management of all stages of acute appendicitis in children: a retrospective study. Pediatr Neonatol. 2012 Oct;53(5):289-94. doi: 10.1016/j.pedneo.2012.07.002. Epub 2012 Sep 1.

    PMID: 23084720RESULT

  • Stipancic I, Zarkovic N, Servis D, Sabolovic S, Tatzber F, Busic Z. Oxidative stress markers after laparoscopic and open cholecystectomy. J Laparoendosc Adv Surg Tech A. 2005 Aug;15(4):347-52. doi: 10.1089/lap.2005.15.347.

    PMID: 16108734RESULT

  • Jakimowicz J, Stultiens G, Smulders F. Laparoscopic insufflation of the abdomen reduces portal venous flow. Surg Endosc. 1998 Feb;12(2):129-32. doi: 10.1007/s004649900612.

    PMID: 9479726RESULT

  • Baysal Z, Togrul T, Aksoy N, Cengiz M, Celik H, Boleken ME, Kaya M, Yavuz G. Evaluation of total oxidative and antioxidative status in pediatric patients undergoing laparoscopic surgery. J Pediatr Surg. 2009 Jul;44(7):1367-70. doi: 10.1016/j.jpedsurg.2008.11.031.

    PMID: 19573663RESULT

  • Aktimur R, Gokakin AK, Deveci K, Atabey M, Topcu O. Oxidative stress markers in laparoscopic vs. open appendectomy for acute appendicitis: A double-blind randomized study. J Minim Access Surg. 2016 Apr-Jun;12(2):143-7. doi: 10.4103/0972-9941.156203.

    PMID: 27073307RESULT

  • Schubert JK, Miekisch W, Geiger K, Noldge-Schomburg GF. Breath analysis in critically ill patients: potential and limitations. Expert Rev Mol Diagn. 2004 Sep;4(5):619-29. doi: 10.1586/14737159.4.5.619.

    PMID: 15347256RESULT

  • Miekisch W, Schubert JK, Noeldge-Schomburg GF. Diagnostic potential of breath analysis--focus on volatile organic compounds. Clin Chim Acta. 2004 Sep;347(1-2):25-39. doi: 10.1016/j.cccn.2004.04.023.

    PMID: 15313139RESULT

  • Pabst F, Miekisch W, Fuchs P, Kischkel S, Schubert JK. Monitoring of oxidative and metabolic stress during cardiac surgery by means of breath biomarkers: an observational study. J Cardiothorac Surg. 2007 Sep 18;2:37. doi: 10.1186/1749-8090-2-37.

    PMID: 17877828RESULT

  • Trefz P, Rosner L, Hein D, Schubert JK, Miekisch W. Evaluation of needle trap micro-extraction and automatic alveolar sampling for point-of-care breath analysis. Anal Bioanal Chem. 2013 Apr;405(10):3105-15. doi: 10.1007/s00216-013-6781-9. Epub 2013 Feb 7.

    PMID: 23388692RESULT

MeSH Terms

Conditions

Appendicitis

Condition Hierarchy (Ancestors)

Intraabdominal InfectionsInfectionsGastroenteritisGastrointestinal DiseasesDigestive System DiseasesCecal DiseasesIntestinal Diseases

Study Officials

  • Holger Till, MD

    Department of Pediatric and Adolescent Surgery, Medical University of Graz

    STUDY DIRECTOR

  • Gert Warncke, MD

    Department of Pediatric and Adolescent Medicine, Medical University of Graz

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Gert Warncke, MD

CONTACT

01143316385gert.warncke@medunigraz.at

Christoph Castellani, MD

CONTACT

01143316385christoph.castellani@medunigraz.at

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Masking Details
After obtaining written informed consent from patients/legal guardians the patients will be randomized 1:1 to one of the two surgical techniques. Randomization is carried out using the web-based "Randomizer for Clinical Trials" program at the Institute of Medical Informatics, Statistics and Documentation at the Medical University of Graz (www.randomizer.at).
Purpose
BASIC SCIENCE
Intervention Model
PARALLEL
Model Details: 40 patients aged 6-18 years suffering from acute appendicitis are to be included. These are divided into 2 groups. Group 1 (n = 20) with laparoscopic and group 2 (n = 20) with open appendectomy.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

July 10, 2018

First Posted

October 29, 2018

Study Start

October 2, 2019

Primary Completion

October 1, 2020

Study Completion

December 1, 2020

Last Updated

July 15, 2020

Record last verified: 2020-07

Data Sharing

IPD Sharing
Will not share

Locations

AU(1)