Clinical trial · Observational
Preserving or Resecting the Normal Appendix in Patients Undergoing Laparoscopy Surgery for Suspected Appendicitis
Normal Diagnostic Laparoscopy Versus Negative Appendectomy in Patients With a Normal Appendix Undergoing Laparoscopic Surgery for Suspected Appendicitis: a Target Trial
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (5)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Abdominal Pain (AP) | — | UNRESOLVED | — |
| Acute Appendicitis | — | UNRESOLVED | — |
| Diagnostic Laparoscopy | — | UNRESOLVED | — |
| Laparoscopic Appendectomy | — | UNRESOLVED | — |
| Neoplasms | Neoplasm | ONTOLOGY_EXACT | 0.90 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Negative appendectomy | Procedure | — | UNRESOLVED |
| Normal diagnostic laparoscopy | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- label
- Normal diagnostic laparoscopy group
- description
- The appendix is left in situ, e.g. not resected and no other surgical procedure is needed to treat other diseases, identified through both the nationwide Danish National Patient Register and Danish Pathology Data Bank
- interventionNames
- Procedure: Normal diagnostic laparoscopy
- label
- Negative appendectomy group
- description
- The appendix is resected but is without histopathological inflammation and no other surgical resection is needed to treat other diseases, identified through both the nationwide Danish National Patient Register and Danish Pathology Data Bank
- interventionNames
- Procedure: Negative appendectomy
Primary outcomes (2)
- measure
- Cancer in the appendix
- timeFrame
- 2 years
Eligibility
Eligibility (as posted)
- Sex
- All
Show eligibility criteria text
Inclusion Criteria: * All ages and sexes * Undergoing laparoscopic surgery for suspected appendicitis from 2005 to 2021 * Resected appendix without inflammation e.g., without appendicitis Exclusion Criteria: * Previous resection of the appendix (e.g., previous appendectomy, or resection of the gut including the appendix before January 1, 2005) based on data from surgical codes in the Danish National Patient Register * Unable to be tracked in the Danish registers, such as a replacement personal identification number, or for those not residing in Denmark based on data from the Civil Registration System * Diagnostic codes indicating appendix cancer at index surgery (C181), thus, not operated for suspected appendicitis * Laparoscopic appendectomy converted to open surgery or other surgical procedures conducted contaminated with laparoscopic appendectomy, indicated a need for other surgical interventions because of disease
References
Publications (0)
Data not yet available