Low vs Medium Pressure Pneumoperitoneum (LoMePneu)

University of Zurich (UZH)

Status: Enrolling

Conditions: Appendicitis Acute

Treatments: Procedure: Laparoscopic appendectomy

Study type: Interventional

Funder types: Other

Identifiers

NCT04949659

1001

Details and patient eligibility

About

The purpose of this study is to asses whether the pressure used for the pneumoperitoneum during laparoscopic surgery in children affects their postoperative pain levels.

Enrollment: 250 estimated patients

Sex: All

Ages: 5+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Prepped and consented for diagnostic laparoscopy for likely acute appendicitis
• 5 years or older
• 15 kg or more
• Parents/legal custodian give consent, patient shows no signs of unwillingness to participate
• Patient is hemodynamically stable

Exclusion criteria

• Clinical signs of four quadrant peritonitis as a clinical sign of perforated appendicitis
• Suspected perityphlitic abscess on preoperative ultrasound
• Preexisting conditions making postoperative assessment of extent of pain and its localization very difficult or impossible, e.g. conditions that are associated with pronounced developmental delays or with communication difficulties
• Parents have inadequate knowledge of German language to understand Informed consent
• Child has inadequate knowledge of German language to allow elicitation of Pain Scores

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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250 participants in 2 patient groups

Low pressure pneumoperitoneum

Experimental group

Description:

Use of low pressure pneumoperitoneum during laparoscopic appendectomy

Treatment:

Procedure: Laparoscopic appendectomy

Medium pressure pneumoperitoneum

Experimental group

Description:

Use of medium pressure pneumoperitoneum during laparoscopic appendectomy

Treatment:

Procedure: Laparoscopic appendectomy