NCT06917612Completed
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 · Last updated 8 Apr 2025
Brief summary (registry, in English)
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.
- Status (registry)
- Completed
- Study type
- Observational
- Enrollment
- 20000 (actual)
- First submitted
- 1 Apr 2025
- Start date
- 1 Jan 2005
- Primary completion date
- 31 Dec 2023
- Lead sponsor
- Herlev Hospital
- Diseases
- Childhood cancers
- NCT number
- NCT06917612
What you commit to
- Study type: Observational
- Participants enrolled: 20000
- From 1 Jan 2005 to the primary completion date, 31 Dec 2023
- No sites listed in no country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- 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
Other illness
- 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
Other
- 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
Who the study is looking for
- All ages and sexes
- Undergoing laparoscopic surgery for suspected appendicitis from 2005 to 2021
- Resected appendix without inflammation e.g., without appendicitis
Sex: All · Does not accept healthy volunteers
This page is information, not medical advice. Discuss any trial with your doctor.