The Efficacy and Safety of Using Prophylactic Abdominal Drainage After Cholecystectomy

NCT05267860 | Completed DMC

• 1 other identifier: Drainage After Cholecystectomy
• Study Type: interventional
• Target: 232
• Locations: 1 country
• Sites: 1

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.

Conditions

Drainage; Laparoscopic Cholecystectomy; Acute Cholecystitis

Keywords

Prophylactic Drainage; Laparoscopic cholecystectomy; Acute cholecystitis.; Upper GI Surgery; Cholecystitis; Choledocholithiasis; Gallbladder Diseases

Outcome Measures

Primary Outcomes (1)

• Morbidity /Complications

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

  30 days after the operation

Secondary Outcomes (2)

• Intraperitoneal abscess

  up to 30 days

• Wound infection/ Surgical site infection

  up to 30 days

Other Outcomes (3)

• Adverse events from the operation

  up to 24 hours

• Mortality

  up to 30 days

• Hospital stay

  up to 30 days

Study Arms (2)

Patients with a prophylactic drain after cholecystectomy

EXPERIMENTAL

Device: Prophylactic Drain

Patients without using any prophylactic Drainage after cholecystectomy

NO INTERVENTION

Interventions

Prophylactic Drain DEVICE

We want to put a prophylactic drain after cholecystectomy.

Patients with a prophylactic drain after cholecystectomy

Eligibility Criteria

• Age: 16 Years - 90 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• Non-cooperative patients for regular follow up.
• Draining for therapeutic indications.

Sponsors & Collaborators

• University of Aleppo: lead

Study Sites (1)

Aleppo University Hospital

Aleppo, Syria

Location

Related Publications (5)

• 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.

  PMID: 24970306 BACKGROUND

• 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.

  PMID: 24000011 BACKGROUND

• 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.

  PMID: 2042093 BACKGROUND

• 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.

  PMID: 26386402 BACKGROUND

• Arnaout AY, Kadoura L, Masri R, Nerabani Y, Atli AA, Arnaout K, Arnaout I, Bsata A, Kayali H, Mahli N, Al-Haj A, Ayoub K, Niazi A, Ghazal A; Aleppo University Hospital Team. The efficacy and safety of using prophylactic abdominal drainage after laparoscopic cholecystectomy: A randomized control trial. Health Sci Rep. 2024 Aug 8;7(8):e2284. doi: 10.1002/hsr2.2284. eCollection 2024 Aug.

  PMID: 39131596 DERIVED

MeSH Terms

Conditions

Cholecystitis, Acute; Cholecystitis; Choledocholithiasis; Gallbladder Diseases

Condition Hierarchy (Ancestors)

Biliary Tract Diseases; Digestive System Diseases; Common Bile Duct Diseases; Bile Duct Diseases; Cholelithiasis

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: February 21, 2022
• First Posted: March 4, 2022
• Study Start: February 1, 2022
• Primary Completion: November 30, 2022
• Study Completion: December 1, 2022
• Last Updated: January 26, 2023

Record last verified: 2023-01

Data Sharing

• IPD Sharing: Will share

Locations

SY (1)