Clinical trial NCT05267860: 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.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Drainage
Laparoscopic Cholecystectomy
Acute Cholecystitis
Keywords: Prophylactic Drainage
Laparoscopic cholecystectomy
Acute cholecystitis.
Upper GI Surgery
Cholecystitis
Choledocholithiasis
Gallbladder Diseases
Lead sponsor: University of Aleppo
Sponsor class: OTHER
First posted: 2022-03-04
Enrollment: 232
Sex: ALL
Minimum age (years): 16
Maximum age (years): 90
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

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.

Primary outcomes:
measure: Morbidity /Complications
timeFrame: 30 days after the operation
Secondary outcomes:
measure: Intraperitoneal abscess
timeFrame: up to 30 days
measure: Wound infection/ Surgical site infection
timeFrame: up to 30 days
Other outcomes:
measure: Adverse events from the operation
timeFrame: up to 24 hours
measure: Mortality
timeFrame: up to 30 days
measure: Hospital stay
timeFrame: up to 30 days
Locations:
city: Aleppo
country: Syrian Arab Republic
facility: Aleppo University Hospital
Study officials:
References:
citation: Antoniou S, Koch O, Antoniou G, Kohler G, Chalkiadakis G, Pointner R, Granderath F. Routine versus no drain placement after elective laparoscopic cholecystectomy: meta-analysis of randomized controlled trials. Minerva Chir. 2014 Jun;69(3):185-94.
citation: Gurusamy KS, Koti R, Davidson BR. Routine abdominal drainage versus no abdominal drainage for uncomplicated laparoscopic cholecystectomy. Cochrane Database Syst Rev. 2013 Sep 3;(9):CD006004. doi: 10.1002/14651858.CD006004.pub4.
citation: Monson JR, Guillou PJ, Keane FB, Tanner WA, Brennan TG. Cholecystectomy is safer without drainage: the results of a prospective, randomized clinical trial. Surgery. 1991 Jun;109(6):740-6.
citation: Wong CS, Cousins G, Duddy JC, Walsh SR. Intra-abdominal drainage for laparoscopic cholecystectomy: A systematic review and meta-analysis. Int J Surg. 2015 Nov;23(Pt A):87-96. doi: 10.1016/j.ijsu.2015.09.033. Epub 2015 Sep 18.