Brief Title
The Efficacy and Safety of Using Prophylactic Abdominal Drainage After Cholecystectomy
Official Title
The Efficacy and Safety of Using Prophylactic Abdominal Drainage After Cholecystectomy: A Randomized Control Trial.
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.
Study Type
Interventional
Primary Outcome
Morbidity /Complications
Secondary Outcome
Intraperitoneal abscess
Condition
Drainage
Intervention
Prophylactic Drain
Study Arms / Comparison Groups
Patients with a prophylactic drain after cholecystectomy
Description:
Publications
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
Recruitment Information
Recruitment Status
Device
Estimated Enrollment
232
Start Date
February 1, 2022
Completion Date
December 1, 2022
Primary Completion Date
November 30, 2022
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.
Gender
All
Ages
16 Years - 90 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Contacts
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Location Countries
Syrian Arab Republic
Location Countries
Syrian Arab Republic
Administrative Informations
NCT ID
NCT05267860
Organization ID
Drainage After Cholecystectomy
Responsible Party
Principal Investigator
Study Sponsor
University of Aleppo
Study Sponsor
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Verification Date
January 2023