Low vs Medium Pressure Pneumoperitoneum

NCT04949659 | Completed

• 1 other identifier: 1001
• Study Type: interventional
• Target: 250
• Locations: 1 country
• Sites: 1

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.

Conditions

Appendicitis Acute

Keywords

Pneumoperitoneum; Pressure; Pain

Outcome Measures

Primary Outcomes (1)

• Postoperative pain score on postoperative day one (abdominal pain)

  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.

  Postoperative day one.

Secondary Outcomes (6)

• Postoperative pain scores during postoperative phase (abdominal pain)

  Through study completion, an average of 3 days

• Postoperative pain scores during postoperative phase (shoulder pain)

  Through study completion, an average of 3 days

• Length of operation

  Intraoperative

• Length of stay

  Through study completion, an average of 3 days

• Intra- and postoperative complications

  Through study completion, an average of 3 days

Study Arms (2)

Low pressure pneumoperitoneum

EXPERIMENTAL

Use of low pressure pneumoperitoneum during laparoscopic appendectomy

Procedure: Laparoscopic appendectomy

Medium pressure pneumoperitoneum

EXPERIMENTAL

Use of medium pressure pneumoperitoneum during laparoscopic appendectomy

Procedure: Laparoscopic appendectomy

Interventions

Laparoscopic appendectomy PROCEDURE

Laparoscopic appendectomy performed with defined, randomized to level of pressure for pneumoperitoneum

Low pressure pneumoperitoneum; Medium pressure pneumoperitoneum

Eligibility Criteria

• Age: 5 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• University Children's Hospital, Zurich: lead

Study Sites (1)

University Children's Hospital Zurich

Zurich, Canton of Zurich, 8032, Switzerland

Location

Related Publications (3)

• Gurusamy KS, Vaughan J, Davidson BR. Low pressure versus standard pressure pneumoperitoneum in laparoscopic cholecystectomy. Cochrane Database Syst Rev. 2014 Mar 18;2014(3):CD006930. doi: 10.1002/14651858.CD006930.pub3.

  PMID: 24639018 BACKGROUND

• Ozdemir-van Brunschot DM, van Laarhoven KC, Scheffer GJ, Pouwels S, Wever KE, Warle MC. What is the evidence for the use of low-pressure pneumoperitoneum? A systematic review. Surg Endosc. 2016 May;30(5):2049-65. doi: 10.1007/s00464-015-4454-9. Epub 2015 Aug 15.

  PMID: 26275545 BACKGROUND

• McGrath PJ, Walco GA, Turk DC, Dworkin RH, Brown MT, Davidson K, Eccleston C, Finley GA, Goldschneider K, Haverkos L, Hertz SH, Ljungman G, Palermo T, Rappaport BA, Rhodes T, Schechter N, Scott J, Sethna N, Svensson OK, Stinson J, von Baeyer CL, Walker L, Weisman S, White RE, Zajicek A, Zeltzer L; PedIMMPACT. Core outcome domains and measures for pediatric acute and chronic/recurrent pain clinical trials: PedIMMPACT recommendations. J Pain. 2008 Sep;9(9):771-83. doi: 10.1016/j.jpain.2008.04.007. Epub 2008 Jun 17.

  PMID: 18562251 BACKGROUND

MeSH Terms

Conditions

Appendicitis; Pneumoperitoneum; Pain

Condition Hierarchy (Ancestors)

Intraabdominal Infections; Infections; Gastroenteritis; Gastrointestinal Diseases; Digestive System Diseases; Cecal Diseases; Intestinal Diseases; Peritoneal Diseases; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Hannah R Neeser, MD

  University Children's Hospital of Zurich

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 21, 2021
• First Posted: July 2, 2021
• Study Start: September 27, 2021
• Primary Completion: January 31, 2025
• Study Completion: January 31, 2025
• Last Updated: February 20, 2026

Record last verified: 2025-01

Data Sharing

• IPD Sharing: Will not share

Locations

CH (1)