The Efficacy and Safety of Using Prophylactic Abdominal Drainage After Cholecystectomy

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

232 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-02-01

Study Completion Date

2022-12-01

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Drainage Laparoscopic Cholecystectomy Acute Cholecystitis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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Patients with a prophylactic drain after cholecystectomy

Group Type EXPERIMENTAL

Prophylactic Drain

Intervention Type DEVICE

We want to put a prophylactic drain after cholecystectomy.

Patients without using any prophylactic Drainage after cholecystectomy

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Prophylactic Drain

We want to put a prophylactic drain after cholecystectomy.

Intervention Type DEVICE

Eligibility Criteria

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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.