Active not recruitingNAINTERVENTIONAL

Fast Track Pathway to Accelerated Cholecystectomy

This study investigates the ideal timing for gallbladder surgery when it becomes inflamed, a condition called cholecystitis. Many people get gallstones, and sometimes these lead to inflammation. If left untreated, this can cause serious problems. While surgery is the main solution, doctors currently have different ideas about when it's best to operate – either very soon after diagnosis or a few weeks later. This research aims to compare an "accelerated" approach, where surgery happens as quickly as possible (ideally within 6 hours), with the usual care. By doing this, we hope to find out if faster surgery can lead to shorter hospital stays, fewer complications, and overall better results for patients.

At a glance

Status

Active not recruiting

Phase

Sponsor

P.J. Devereaux

Enrolment target

Start

22 Jan 2020

Estimated completion

15 May 2025

Cholecystitis Cholecystectomy

What is this study about?

Many people develop gallstones, which are small, hard deposits that can form in your gallbladder. Sometimes, these gallstones can block a tube in your gallbladder, causing it to become inflamed and painful. This condition is called acute cholecystitis. While it's very important to treat this, because it can lead to serious health problems, doctors don't always agree on the best time to perform the surgery to remove the gallbladder, which is called a cholecystectomy.

Currently, some doctors prefer to operate quickly, often within a week of diagnosis. Others might wait a few weeks before performing the surgery. This study wants to see if having surgery much faster, ideally within just six hours of being diagnosed, is better for patients. We're comparing this "fast track" approach to the standard way of doing things, where the exact timing depends on the hospital and the doctor.

The idea behind this study is to find out if early surgery can help patients recover faster, spend less time in the hospital, and have fewer problems overall. Previous research suggests this might be the case, but we need more solid evidence. This study is an important step towards understanding the best way to care for patients with an inflamed gallbladder, helping to improve their treatment and well-being.

Key takeaways

The study compares fast gallbladder surgery with standard timings.
It aims to see if earlier surgery improves recovery and reduces complications.
You need to have an inflamed gallbladder (acute cholecystitis) and meet certain health criteria.
Participation involves tracking your surgery timing and recovery.
This research helps doctors understand the best time to operate.
You can leave the study whenever you wish.

Who may be eligible?

To be considered for this study, you need to be at least 45 years old. If you're between 18 and 44, you might still be included if you also have certain health conditions like diabetes or long-term heart, lung, or kidney problems. You must have been diagnosed with acute cholecystitis, meaning your gallbladder is inflamed. This diagnosis requires showing at least two of the following: pain in the upper right part of your tummy, a specific pain when your doctor presses on your abdomen (Murphy's sign), a high white blood cell count, or a body temperature that is either a bit low or high.

Additionally, an ultrasound scan needs to confirm that you have gallstones or sludge in your gallbladder and signs of cholecystitis. The study is specifically for cases where surgery is needed and diagnosed during normal working hours, and you're expected to stay in the hospital for at least one night after your operation. You also need to agree to take part and give your written permission.

You won't be able to join if you need urgent surgery or treatment for another emergency. Also, if you're on blood thinners that can't be easily stopped, or if you have a history of a specific reaction to blood thinners and are currently on warfarin with a certain blood clotting level, you won't be eligible. Pregnant patients or those who have already participated in this study before also cannot take part.

Could this study suit you?

Answer these quick questions to see if you may be eligible. This is a guide only — the research team makes the final call.

Are you 45 or older? (Or 18-44 with certain health conditions like diabetes, heart, lung, or kidney disease?)
Have you been diagnosed with an inflamed gallbladder needing surgery?
Do you have gallstones or sludge shown on an ultrasound?
Are you able to provide written permission (consent) to join the study?

Answer every question to see your result.

What does participation involve?

If you decide to take part in this study, the main part of your involvement will be around the timing of your gallbladder surgery (cholecystectomy). The study aims to compare having surgery very quickly after diagnosis (within 6 hours if possible) with the standard care, where the timing might be a bit more varied. You will have regular checks, likely including blood tests and scans, as part of your usual care, and the study will collect information about your hospital stay and recovery. The total duration of your participation will involve tracking your recovery after surgery. Specific details about follow-up appointments will be explained fully if you are eligible.

Potential risks and benefits

Participating in this study might offer the benefit of potentially receiving earlier surgical treatment for your inflamed gallbladder, which some evidence suggests could lead to a quicker recovery and fewer complications than waiting. However, all surgeries carry risks, such as infection, bleeding, or reactions to anaesthesia, and the risks associated with this specific surgery remain the same regardless of the timing. You have the right to withdraw from the study at any time without affecting the quality of your future medical care.

Locations (4)

Hamilton General Hospital
Verified postcode
Hamilton, Canada
Juravinski Hospital
Verified postcode
Hamilton, Canada
St. Joseph's Healthcare
Verified postcode
Hamilton, Canada
Lawson Health Research Institute, London Health Sciences Centre
Verified postcode
London, Canada

Common questions

What is an inflamed gallbladder (acute cholecystitis)?

It's when your gallbladder becomes swollen and painful, usually because gallstones are blocking the tube leading from it.

Why is the timing of surgery important?

Doctors are trying to find out if having surgery very soon after diagnosis leads to better outcomes, like a faster recovery, compared to waiting a bit longer.

Will I definitely have surgery within 6 hours?

The study aims for surgery within 6 hours for one group, but it compares this to standard care. You'll discuss with your doctor which group you might be in.

What is a cholecystectomy?

It is the surgical procedure to remove your gallbladder.

What if I change my mind about participating?

You can withdraw from the study at any time, and it won't affect your medical care.