The Efficacy and Safety of Using Prophylactic Abdominal Drainage After Cholecystectomy

Study Overview
=================
Brief Summary
-----------------
Investigators want to assess the safety and efficacy of using abdominal drainage with not using any drainage, by estimating different outcomes after laparoscopic cholecystectomy for different reasons. Patients are seen at the Accident and Emergency Department or in the surgical wards at Aleppo University Hospital (AUH) over 12 months period.

Detailed Description
-----------------
The routine use of prophylactic drainage has become common in many hospitals around the world after cholecystectomy for different reasons. In elective surgeries, the evidence does not support the use of drainage. But in emergency laparoscopic cholecystectomy surgeries, using drainage remains controversial. Surgeons who support the use of drainage find it useful to identify the early complications of surgery and removing intra-abdominal collections, while opponents of drainage use believe that it increases the risk of wound infection. But, a systematic review and meta-analysis discussed the ineffectiveness of the routine use of the prophylactic drainage after laparoscopic cholecystectomy for acute cholecystitis and requested more randomized clinical trial studies on the subject. However, this study and others in the medical literature contain very few high-quality randomized controlled trials, hence our randomized controlled trial compares the use and non-use of drainage in patients undergoing laparoscopic cholecystectomy for different reasons.

Official Title
-----------------
The Efficacy and Safety of Using Prophylactic Abdominal Drainage After Cholecystectomy: A Randomized Control Trial.

Conditions
-----------------
Drainage, Laparoscopic Cholecystectomy, Acute Cholecystitis

Intervention / Treatment
-----------------
* Device: Prophylactic Drain


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients are seen at the Accident and Emergency Department or in the surgical wards at Aleppo University Hospital (AUH) over 12 months period. Patients who undergo cholecystectomy for any reason. Exclusion Criteria: Non-cooperative patients for regular follow up. Draining for therapeutic indications.

Ages Eligible for Study
-----------------
Minimum Age: 16 Years
Maximum Age: 90 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Patients with a prophylactic drain after cholecystectomy<br> | Device: Prophylactic Drain<br>* We want to put a prophylactic drain after cholecystectomy.<br>|
| No Intervention: Patients without using any prophylactic Drainage after cholecystectomy<br> | |

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Morbidity /Complications | overall complication rate; graded by the Clavien- Dindo complications classification system. | 30 days after the operation | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Intraperitoneal abscess | The patient will be monitored and followed up for 30 days after the surgery, and the necessary investigations will be requested to diagnose if the patient has an Intraperitoneal abscess | up to 30 days | 
| Wound infection/ Surgical site infection | Surgical site infection has been defined and classified as superficial incisional, deep incisional, and organ/ space_ surgical site infection by the Centers for Disease Control and Prevention (CDC) (Anderson 2014; Ban 2017; Berríos-Torres 2017). | up to 30 days | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Cholecystitis, Choledocholithiasis, Gallbladder Diseases, Prophylactic Drainage, Laparoscopic cholecystectomy, Acute cholecystitis., Upper GI Surgery