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

NCT06917612 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 20000

Last updated 2025-04-08

No results posted yet for this study

Summary

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.

Conditions

  • Acute Appendicitis
  • Abdominal Pain (AP)
  • Diagnostic Laparoscopy
  • Laparoscopic Appendectomy
  • Neoplasms

Interventions

PROCEDURE

Normal diagnostic laparoscopy

The appendix is left in situ e.g., not resected and no other surgical resection is needed to treat other diseases

PROCEDURE

Negative appendectomy

The appendix is resected but is without histopathological-confirmed inflammation and no other surgical resection is needed to treat other diseases

Sponsors & Collaborators

  • Danish Institute for Public Health

    collaborator OTHER

  • Herlev Hospital

    lead OTHER

Principal Investigators

  • Siv Fonnes, MD, PhD · Herlev Hospital

Eligibility

Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2005-01-01
Primary Completion
2023-12-31
Completion
2023-12-31

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06917612 on ClinicalTrials.gov