Low vs Medium Pressure Pneumoperitoneum

Not Applicable

Recruiting

• Conditions: Appendicitis Acute
• Interventions: Procedure: Laparoscopic appendectomy

• Registration Number: NCT04949659
• Lead Sponsor: University Children's Hospital, Zurich

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2021-06-21
• Study First Submitted QC: 2021-06-30
• Study First Posted: 2021-07-02
• Study Start: 2021-09-27
• Status Verified: 2024-04
• Last Update Submitted: 2024-04-24
• Last Update Posted: 2024-04-25
• Primary Completion: 2025-03
• Study Completion: 2025-06

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 250

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Low pressure pneumoperitoneum	Laparoscopic appendectomy	Use of low pressure pneumoperitoneum during laparoscopic appendectomy
Medium pressure pneumoperitoneum	Laparoscopic appendectomy	Use of medium pressure pneumoperitoneum during laparoscopic appendectomy

Primary Outcome Measures

Name	Time	Method
Postoperative pain score on postoperative day one (abdominal pain)	Postoperative day one.	Postoperative pain score for abdominal pain on postoperative day one after laparoscopic appendectomy using the Faces Pain Score Revised (FPS-R score), a self-reported pain score using drawn faces with values from 0 (no pain) to 10 (most pain). It is validated for use in studies with children.

Secondary Outcome Measures

Name	Time	Method
Analgesic use	Through study completion, an average of 3 days	Number and dose (mg/kg) of standard analgesia, as well as so called "rescue" doses
Length of operation	Intraoperative	Length of operation in minutes
Length of stay	Through study completion, an average of 3 days	Length of stay in hospital in hours
Postoperative pain scores during postoperative phase (abdominal pain)	Through study completion, an average of 3 days	Postoperative pain score for abdominal pain on further postoperative days (excluding day one, which is primary outcome) after laparoscopic appendectomy using the Faces Pain Score Revised (FPS-R score), a self-reported pain score using drawn faces with values from 0 (no pain) to 10 (most pain). It is validated for use in studies with children.
Postoperative pain scores during postoperative phase (shoulder pain)	Through study completion, an average of 3 days	Postoperative pain score for shoulder pain during hospitalisation after laparoscopic appendectomy using the Faces Pain Score Revised (FPS-R score), a self-reported pain score using drawn faces with values from 0 (no pain) to 10 (most pain). It is validated for use in studies with children.
Intra- and postoperative complications	Through study completion, an average of 3 days	Intra- and postoperative complications during hospitalisation

Trial Locations

Locations (1)

University Children's Hospital Zurich; 🇨🇭 Zürich, Zurich, Switzerland