Skip to main content
OpenTrials
Completed

NCT Number: NCT05267860

The Efficacy and Safety of Using Prophylactic Abdominal Drainage After Cholecystectomy

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.

Completed

Looking for future studies?

Notify Me

Key information

Age range

16 year–90 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Aleppo University Hospital

Aleppo, Syria

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Prophylactic Drain

Device

We want to put a prophylactic drain after cholecystectomy.

Primary outcomes

  1. Morbidity /Complications

    Time frame: 30 days after the operation

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

Secondary outcomes

  1. Intraperitoneal abscess

    Time frame: up to 30 days

    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

  2. Wound infection/ Surgical site infection

    Time frame: up to 30 days

    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).

Other outcomes

  1. Adverse events from the operation

    Time frame: up to 24 hours

  2. Mortality

    Time frame: up to 30 days

  3. Hospital stay

    Time frame: up to 30 days

    Number of days, patient in hospital since admission

Sponsors and collaborators

Lead sponsor

University of Aleppo

Other

Registry information

Official study title

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

Important dates

Study start
2022
Primary completion
2022
Study completion
2022
First posted
Mar 4, 2022
Registry last updated
Jan 26, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.