DrainageNCT05267860
The Efficacy and Safety of Using Prophylactic Abdominal Drainage After Cholecystectomy
A study testing Prophylactic Drain in people with Drainage and Laparoscopic Cholecystectomy, run by University of Aleppo at 1 site in Syria.
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. Read more about this study
- Who is it for?
- Ages 16 to 90 yearsHealthy volunteers can take part
- Conditions the study is for
- Drainage, Laparoscopic Cholecystectomy, Acute Cholecystitis
- What is being tested?
- Prophylactic Drain
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 232 participants
- Where
- 1 siteSyria
- Study dates
- 1 Feb 2022to 1 Dec 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 16 to 90 years
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- Non-cooperative patients for regular follow up.
- Draining for therapeutic indications.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Efficacy and Safety of Using Prophylactic Abdominal Drainage After Cholecystectomy: A Randomized Control Trial.
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.
Read the 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.
- Conditions
- Drainage, Laparoscopic Cholecystectomy, Acute Cholecystitis
- Being tested
- Prophylactic Drain
- Keywords
- Prophylactic Drainage, Laparoscopic cholecystectomy, Acute cholecystitis., Upper GI Surgery, Cholecystitis, Choledocholithiasis, Gallbladder Diseases
- Medical subject headings
- Cholecystitis, Acute, Cholecystitis, Choledocholithiasis, Gallbladder Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Prophylactic DrainDevice
We want to put a prophylactic drain after cholecystectomy.
| Study group | Role | What they receive |
|---|---|---|
| Patients with a prophylactic drain after cholecystectomy | Experimental | Not described Receives: Device: Prophylactic Drain |
| Patients without using any prophylactic Drainage after cholecystectomy | No intervention | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Morbidity /Complications
overall complication rate; graded by the Clavien- Dindo complications classification system.
Measured: 30 days after the operation
Secondary outcomes (2)
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
Measured: up to 30 days
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).
Measured: up to 30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Mar 2022
- Study start1 Feb 2022
- Primary completion30 Nov 2022
- Study completion1 Dec 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for DrainageStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 232 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Aleppo
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ahmad Yamen Arnaout, University of Aleppo
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05267860
- Sponsor's protocol ID
- Drainage After Cholecystectomy
- Status last verified
- Jan 2023
- First submitted
- 21 Feb 2022
- Last updated
- 26 Jan 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: We will publish the data after publishing the research.
Publications
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.
PubMed 24970306Gurusamy KS, Koti R, Davidson BR. Routine abdominal drainage versus no abdominal drainage for uncomplicated laparoscopic cholecystectomy. Cochrane Database Syst Rev. 2013 Sep 3;2013(9):CD006004. doi: 10.1002/14651858.CD006004.pub4.
PubMed 24000011Monson 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.
PubMed 2042093Wong 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.
PubMed 26386402Arnaout 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.
PubMed 39131596
Study at a glance
From the registry record, last updated by the sponsor on 26 Jan 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Efficacy and Safety of Using Prophylactic Abdominal Drainage After Cholecystectomy: A Randomized Control Trial.
- ClinicalTrials.gov ID
- NCT05267860
- Acronym / sponsor ID
- Drainage After Cholecystectomy
- Conditions
- Drainage, Laparoscopic Cholecystectomy, Acute Cholecystitis
- Keywords
- Prophylactic Drainage, Laparoscopic cholecystectomy, Acute cholecystitis., Upper GI Surgery, Cholecystitis, Choledocholithiasis, Gallbladder Diseases
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 232 participants (actual)
- Lead sponsor
- University of AleppoUniversity, hospital or other
- Study start
- 1 Feb 2022 (actual)
- Primary completion
- 30 Nov 2022 (actual)
- Study completion
- 1 Dec 2022 (actual)
- First posted
- 4 Mar 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Patients with a prophylactic drain after cholecystectomy | Experimental | Device: Prophylactic Drain |
| Patients without using any prophylactic Drainage after cholecystectomy | No intervention | – |
Who may qualify
- Ages
- 16 to 90 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (2 listed)
- 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.
Key exclusion criteria (2 listed)
- Non-cooperative patients for regular follow up.
- Draining for therapeutic indications.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Prophylactic DrainWe want to put a prophylactic drain after cholecystectomy. | Device | Patients with a prophylactic drain after cholecystectomy |
Primary outcome
Morbidity /Complications
Time frame: 30 days after the operation
overall complication rate; graded by the Clavien- Dindo complications classification system.
2 secondary outcomes
Intraperitoneal abscess
Time frame: up to 30 days
Wound infection/ Surgical site infection
Time frame: up to 30 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Jan 2023.
- Background: PubMed 24970306Antoniou 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.
- Background: PubMed 24000011Gurusamy KS, Koti R, Davidson BR. Routine abdominal drainage versus no abdominal drainage for uncomplicated laparoscopic cholecystectomy. Cochrane Database Syst Rev. 2013 Sep 3;2013(9):CD006004. doi: 10.1002/14651858.CD006004.pub4.
- Background: PubMed 2042093Monson 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.
- Background: PubMed 26386402Wong 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.
- Derived from this study: PubMed 39131596Arnaout 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.
- Individual participant dataSharing planned: Yes. We will publish the data after publishing the research.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Prophylactic Drain in people with Drainage and Laparoscopic Cholecystectomy, run by University of Aleppo at 1 site in Syria.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 26 Jan 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Syria. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Morbidity /Complications (time frame: 30 days after the operation). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05267860, which also lists 5 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Jan 2023.