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

NCT06917612 | Completed

• 1 other identifier: HEH-SF-03
• Study Type: observational
• Target: 20,000
• Locations: 0 countries
• Sites: N/A

Brief 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

Outcome Measures

Primary Outcomes (2)

• Cancer in the appendix

  Histopathologically verified cancer in the appendix (primary or metastasis) in the nationwide register the Danish Pathology Data Bank e.g., SNOMED morphology codes for cancer (M8\*\*\*\* or M9\*\*\*\*) in relation to the topography code of the appendix (T66000)

  2 years

• Appendix cancer

  Histopathologically verified appendix cancer (primary) in the nationwide register the Danish Pathology Data Bank e.g., SNOMED morphology codes for cancer (M8\*\*\*\* or M9\*\*\*\*) in relation to the topography code of the appendix (T66000)

  2 years

Secondary Outcomes (6)

• Delay in diagnosis of cancer

  2 years

• Death

  2 years

• Any reoperation

  1 year

• Abdominal reoperation

  1 year

• Resected appendix

  2 years

Other Outcomes (5)

• Subgroup analysis for outcomes at 1 year follow-up

  1 year

• Subgroup analysis for outcomes at 2 years follow-up

  2 year

• Subgroup analysis for outcomes at 5 years follow-up

  5 year

Study Arms (2)

Normal diagnostic laparoscopy group

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

Procedure: Normal diagnostic laparoscopy

Negative appendectomy group

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

Procedure: Negative appendectomy

Interventions

Normal diagnostic laparoscopy PROCEDURE

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

Normal diagnostic laparoscopy group

Negative appendectomy PROCEDURE

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

Negative appendectomy group

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients of all ages undergoing laparoscopic surgery for suspected appendicitis, as recorded in the nationwide Danish National Patient Register, are identified via diagnostic and surgical codes. Information on negative appendectomies is retrieved from the nationwide register of the Danish Pathology Data Bank. We will use inverse probability weighting to adjust for and minimise bias derived from an imbalance in baseline covariates (sex, age, year of surgery, and hospital).

You may qualify if:

• All ages and sexes
• Undergoing laparoscopic surgery for suspected appendicitis from 2005 to 2021
• Resected appendix without inflammation e.g., without appendicitis

You may not qualify if:

• 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

Sponsors & Collaborators

• Herlev Hospital: lead
• Danish Institute for Public Health: collaborator

MeSH Terms

Conditions

Appendicitis; Abdominal Pain; Neoplasms

Condition Hierarchy (Ancestors)

Intraabdominal Infections; Infections; Gastroenteritis; Gastrointestinal Diseases; Digestive System Diseases; Cecal Diseases; Intestinal Diseases; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Signs and Symptoms, Digestive

Study Officials

• Siv Fonnes, MD, PhD

  Herlev Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Researcher, MD, PhD

Study Record Dates

• First Submitted: April 1, 2025
• First Posted: April 8, 2025
• Study Start: January 1, 2005
• Primary Completion: December 31, 2023
• Study Completion: December 31, 2023
• Last Updated: April 8, 2025

Record last verified: 2025-04

Data Sharing

• IPD Sharing: Will not share