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The Efficacy and Safety of Using Prophylactic Abdominal Drainage After Cholecystectomy

Primary Purpose

Drainage, Laparoscopic Cholecystectomy, Acute Cholecystitis

Status
Completed
Phase
Not Applicable
Locations
Syrian Arab Republic
Study Type
Interventional
Intervention
Prophylactic Drain
Sponsored by
University of Aleppo
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Drainage focused on measuring Prophylactic Drainage, Laparoscopic cholecystectomy, Acute cholecystitis., Upper GI Surgery, Cholecystitis, Choledocholithiasis, Gallbladder Diseases

Eligibility Criteria

16 Years - 90 Years (Child, Adult, Older Adult)All SexesAccepts 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.

Sites / Locations

  • Aleppo University Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Patients with a prophylactic drain after cholecystectomy

Patients without using any prophylactic Drainage after cholecystectomy

Arm Description

Outcomes

Primary Outcome Measures

Morbidity /Complications
overall complication rate; graded by the Clavien- Dindo complications classification system.

Secondary Outcome Measures

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
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).

Full Information

First Posted
February 21, 2022
Last Updated
January 23, 2023
Sponsor
University of Aleppo
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1. Study Identification

Unique Protocol Identification Number
NCT05267860
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.
Study Type
Interventional

2. Study Status

Record Verification Date
January 2023
Overall Recruitment Status
Completed
Study Start Date
February 1, 2022 (Actual)
Primary Completion Date
November 30, 2022 (Actual)
Study Completion Date
December 1, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Aleppo

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Drainage, Laparoscopic Cholecystectomy, Acute Cholecystitis
Keywords
Prophylactic Drainage, Laparoscopic cholecystectomy, Acute cholecystitis., Upper GI Surgery, Cholecystitis, Choledocholithiasis, Gallbladder Diseases

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
232 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Patients with a prophylactic drain after cholecystectomy
Arm Type
Experimental
Arm Title
Patients without using any prophylactic Drainage after cholecystectomy
Arm Type
No Intervention
Intervention Type
Device
Intervention Name(s)
Prophylactic Drain
Intervention Description
We want to put a prophylactic drain after cholecystectomy.
Primary Outcome Measure Information:
Title
Morbidity /Complications
Description
overall complication rate; graded by the Clavien- Dindo complications classification system.
Time Frame
30 days after the operation
Secondary Outcome Measure Information:
Title
Intraperitoneal abscess
Description
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
Time Frame
up to 30 days
Title
Wound infection/ Surgical site infection
Description
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).
Time Frame
up to 30 days
Other Pre-specified Outcome Measures:
Title
Adverse events from the operation
Time Frame
up to 24 hours
Title
Mortality
Time Frame
up to 30 days
Title
Hospital stay
Description
Number of days, patient in hospital since admission
Time Frame
up to 30 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
16 Years
Maximum Age & Unit of Time
90 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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.
Facility Information:
Facility Name
Aleppo University Hospital
City
Aleppo
Country
Syrian Arab Republic

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
We will publish the data after publishing the research.
Citations:
PubMed Identifier
24970306
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.
Results Reference
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PubMed Identifier
24000011
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.
Results Reference
background
PubMed Identifier
2042093
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.
Results Reference
background
PubMed Identifier
26386402
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.
Results Reference
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The Efficacy and Safety of Using Prophylactic Abdominal Drainage After Cholecystectomy

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