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The Efficacy and Safety of Using Prophylactic Abdominal Drainage After Cholecystectomy

U

University of Aleppo

Status

Completed

Conditions

Laparoscopic Cholecystectomy
Acute Cholecystitis
Drainage

Treatments

Device: Prophylactic Drain

Study type

Interventional

Funder types

Other

Identifiers

NCT05267860
Drainage After Cholecystectomy

Details and patient eligibility

About

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.

Full 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.

Enrollment

232 patients

Sex

All

Ages

16 to 90 years old

Volunteers

Accepts Healthy Volunteers

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.

Trial design

Primary purpose

Prevention

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

232 participants in 2 patient groups

Patients with a prophylactic drain after cholecystectomy
Experimental group
Treatment:
Device: Prophylactic Drain
Patients without using any prophylactic Drainage after cholecystectomy
No Intervention group

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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