Investigation of Oxidative Stress in Appendectomy - Open Versus Laparoscopic in Childhood and Adolescence

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.

Conditions

• Appendicitis Acute

Interventions

DIAGNOSTIC_TEST

Initial serum malondialdehyde level

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)

DIAGNOSTIC_TEST

Final serum malondialdehyde level

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

DIAGNOSTIC_TEST

Initial differential white blood cell count

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

DIAGNOSTIC_TEST

Final differential white blood cell count

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).

DIAGNOSTIC_TEST

Initial c-reactive protein serum level

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

DIAGNOSTIC_TEST

Final c-reactive protein serum level

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).

DIAGNOSTIC_TEST

Initial VOC

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

DIAGNOSTIC_TEST

VOC 5min

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

DIAGNOSTIC_TEST

VOC 15min

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

DIAGNOSTIC_TEST

VOC 30min

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

DIAGNOSTIC_TEST

VOC 45min

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

DIAGNOSTIC_TEST

Final VOC

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

Sponsors & Collaborators

• University of Rostock

  collaborator OTHER

• Graz University of Technology

  collaborator OTHER

• Medical University of Graz

  lead OTHER

Principal Investigators

• Holger Till, MD · Department of Pediatric and Adolescent Surgery, Medical University of Graz

• Gert Warncke, MD · Department of Pediatric and Adolescent Medicine, Medical University of Graz

Study Design

Allocation

RANDOMIZED

Purpose

BASIC_SCIENCE

Masking

SINGLE

Model

PARALLEL

Eligibility

Min Age

6 Years

Max Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2019-10-02

Primary Completion

2020-10-01

Completion

2020-12-01

Countries

• Austria

Study Locations