Low vs Medium Pressure Pneumoperitoneum

University Children's Hospital, Zurich250 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Enrollment

250

Conditions

Appendicitis Acute

Interventions

Laparoscopic appendectomyPROCEDURE

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

Eligibility

Sex: ALLMin age: 5 Years

Medical Language ↔ Plain English

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

Locations (1)

University Children's Hospital Zurich

Zurich, Canton of Zurich, Switzerland

RECRUITING

Outcomes

Primary Outcomes

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.

Time frame: Postoperative day one.

Secondary Outcomes

Postoperative pain scores during postoperative phase (abdominal pain)

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.

Time frame: Through study completion, an average of 3 days

Postoperative pain scores during postoperative phase (shoulder pain)

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.

Time frame: Through study completion, an average of 3 days

Length of operation

Length of operation in minutes

Time frame: Intraoperative

Length of stay

Length of stay in hospital in hours

Time frame: Through study completion, an average of 3 days

Intra- and postoperative complications

Intra- and postoperative complications during hospitalisation

Central Contacts

Hannah R Neeser, MD

CONTACT

+41442667045 Hannah.Neeser@kispi.uzh.ch

Ueli Moehrlen, MD

CONTACT

+41442667407 Ueli.moehrlen@kispi.uzh.ch

Data from ClinicalTrials.gov

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