NCT06917612

Preserving or Resecting the Normal Appendix in Patients Undergoing Laparoscopy Surgery for Suspected Appendicitis

Completed Last updated 8 April 2025

What this trial tests

trial testing Normal diagnostic laparoscopy in Acute Appendicitis in 20,000 participants. Completed in 31 December 2023.

Timeline

1 January 2005

Primary endpoint
31 December 2023

31 December 2023

Quick facts

Lead sponsor	Herlev Hospital
Status	Completed
Study type	OBSERVATIONAL
Enrollment	20,000
Start date	1 January 2005
Primary completion	31 December 2023
Estimated completion	31 December 2023

Drugs / interventions tested

• Normal diagnostic laparoscopy
• Negative appendectomy

Conditions studied

• Acute Appendicitis — all drugs for Acute Appendicitis →
• Abdominal Pain (AP) — all drugs for Abdominal Pain (AP) →
• Diagnostic Laparoscopy — all drugs for Diagnostic Laparoscopy →
• Laparoscopic Appendectomy — all drugs for Laparoscopic Appendectomy →

Sponsor

Herlev Hospital

Who can join

Eligibility, any sex, with Acute Appendicitis or Abdominal Pain (AP). Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

When appendicitis is suspected, patients are typically planned for emergency surgery preferably using a laparoscopic approach. Up to 20% of these patients will have a normal appendix, thus not suffering from appendicitis. Surgeons can either perform a normal diagnostic laparoscopy (leave the appendix in situ) or perform a negative appendectomy (resect the normal appendix). International guidelines recommend negative appendectomy based on weak evidence due to the risk of appendix cancer, but some countries and researchers advocate against negative appendectomy as these patients may experience more harm than if the appendix is left in situ. There are limited national guidelines and the decision is often left to the operating surgeon. Surgeons performing negative appendectomies argue that these prevent microappendicitis and the risk of a subsequent episode of appendicitis. As appendix cancers are rare, and a randomised controlled trial including this subgroup of patients with normal appendices undergoing emergency surgery for suspected appendicitis is unfeasible, an emulated target trial is planned.

This target trial aims to evaluate the effect of a normal diagnostic laparoscopy versus negative appendectomy during laparoscopic surgery for suspected appendicitis regarding cancer in the appendix and other complications such as death, reoperation, and readmission.

Publications & conference data

No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.