The Efficacy and Safety of Using Prophylactic Abdominal Drainage After Cholecystectomy

Laparoscopic Cholecystectomy Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05267860
• Other study ID #: Drainage After Cholecystectomy
• Status: Completed
• Phase: N/A
• Start date: February 1, 2022
• Est. completion date: December 1, 2022

Study information

• Verified date: January 2023
• Source: University of Aleppo
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 232
• Est. completion date: December 1, 2022
• Est. primary completion date: November 30, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 16 Years to 90 Years

Eligibility

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.

Related Conditions & MeSH terms

• Acute Cholecystitis
• Cholecystitis
• Cholecystitis, Acute
• Drainage
• Laparoscopic Cholecystectomy

Intervention

Device:
• Prophylactic Drain
We want to put a prophylactic drain after cholecystectomy.

Locations

Country	Name	City	State
Syrian Arab Republic	Aleppo University Hospital	Aleppo

Sponsors (1)

Lead Sponsor	Collaborator
University of Aleppo

Country where clinical trial is conducted

Syrian Arab Republic, 

References & Publications (4)

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. — View 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. — View 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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Adverse events from the operation		up to 24 hours
Other	Mortality		up to 30 days
Other	Hospital stay	Number of days, patient in hospital since admission	up to 30 days
Primary	Morbidity /Complications	overall complication rate; graded by the Clavien- Dindo complications classification system.	30 days after the operation
Secondary	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
Secondary	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