Clinical Trials Logo

Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT05267860
Other study ID # Drainage After Cholecystectomy
Secondary ID
Status Completed
Phase N/A
First received
Last updated
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
Health authority
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.

Study Design


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
See also
  Status Clinical Trial Phase
Completed NCT03670849 - Image Fusion in the OR N/A
Withdrawn NCT04561583 - Effectiveness and Safety of LED Light Source System for Endoscope N/A
Completed NCT00872287 - Pain in Single Incision Laparoscopic Surgery Cholecystectomy Phase 4
Recruiting NCT06017167 - Prophylaxis Against Postoperative Nausea and Vomiting After Laparoscopic Cholecystectomy Phase 2
Completed NCT05536557 - Bilateral External Oblique İntercostal (EOI) Plane Block in Patients Undergoing Laparoscopic Cholecystectomy. N/A
Recruiting NCT05794503 - Postoperative Urinary Retention After Reversal of Neuromuscular Block by Neostigmine Versus Sugammadex Early Phase 1
Completed NCT05998317 - Dexamethasone at Night vs at Induction on PONV After Laparoscopic Cholecystectomy Phase 2/Phase 3
Completed NCT04759079 - The Effects of Acupuncture Against Postoperative Nausea and Vomit After Laparoscopic Cholecystectomy N/A
Recruiting NCT04138472 - Comparison Of Dexmedetomidine, Fentanyl And Lignocaine In Attenuation Of Hemodynamic Response To Direct Laryngoscopy And Intubation In Patient Undergoing Laparoscopic Cholecystectomy N/A
Recruiting NCT06022926 - Investigation of the Intraoperative and Postoperative Effects of Warming Patients in Laparoscopic Cholecystectomy N/A
Completed NCT02469831 - Respiratory Mechanics and Metabolic Changes During Low Pressure Laparoscopic Cholecystectomy Phase 2
Completed NCT03067038 - Single Incision Versus Three Port Laparoscopic Cholecystectomy N/A
Completed NCT00886210 - Clinical Impact of Routine Abdominal Drainage After Laparoscopic Cholecystectomy N/A
Completed NCT00292214 - Comparing Intravenous and Oral Paracetamol for Cholecystectomy Phase 4
Recruiting NCT05533580 - Differential Effects of Remimazolam and Propofol on Dynamic Cerebral Autoregulation During General Anesthesia N/A
Recruiting NCT05533567 - Electroencephalographic Profiles During General Anesthesia: a Comparative Study of Remimazolam and Propofol N/A
Active, not recruiting NCT05636475 - The Effect Of Machine-Based And Manually Applied Hand Massage On Pain, Anxiety And Gastrointestinal System Functions After Laparoscopic Cholecystectomy Surgery N/A
Recruiting NCT05094193 - Trocar-site Infiltration Versus TAP-block N/A
Completed NCT03323684 - Quadratus Lumborum Block vs Transversus Abdominis Plane Block for Post-cholecystectomy Analgesia N/A
Recruiting NCT04162106 - Feasibility of the Ultravision™ System in Low Pressure Laparoscopic Cholecystectomy Compared to Airseal® IFS N/A