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The Efficacy and Safety of Using Prophylactic Abdominal Drainage After Cholecystectomy

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05267860
Enrollment
232
Registered
2022-03-04
Start date
2022-02-01
Completion date
2022-12-01
Last updated
2023-01-26

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Acute Cholecystitis, Drainage, Laparoscopic Cholecystectomy

Keywords

Prophylactic Drainage, Laparoscopic cholecystectomy, Acute cholecystitis., Upper GI Surgery, Cholecystitis, Choledocholithiasis, Gallbladder Diseases

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.

Interventions

DEVICEProphylactic Drain

We want to put a prophylactic drain after cholecystectomy.

Sponsors

University of Aleppo
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
16 Years to 90 Years
Healthy volunteers
Yes

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.

Design outcomes

Primary

MeasureTime frameDescription
Morbidity /Complications30 days after the operationoverall complication rate; graded by the Clavien- Dindo complications classification system.

Secondary

MeasureTime frameDescription
Intraperitoneal abscessup to 30 daysThe 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
Wound infection/ Surgical site infectionup to 30 daysSurgical 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).

Other

MeasureTime frameDescription
Adverse events from the operationup to 24 hours
Mortalityup to 30 days
Hospital stayup to 30 daysNumber of days, patient in hospital since admission

Countries

Syria

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 5, 2026