Postoperative ComplicationsNCT06246422
Tranexamic Acid Instillation in Laparoscopic Cholecystectomy
A study testing Tranexamic Acid 500 MG and Normal saline in people with Postoperative Complications, run by Tanta University at 1 site in Egypt.
Trial summary
Adult patients undergoing laparoscopic cholecystectomy are at high risk to develop postoperative bleeding especially in the presence of severe adhesions. Local instillation of the antifibrinolytic (tranexamic acid) at the gall bladder bed may decrease the risk of bleeding. Read more about this study
- Who is it for?
- Ages 21 to 60 years
- Conditions the study is for
- Postoperative Complications
- What is being tested?
- Tranexamic Acid 500 MG and Normal saline
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 91 participants
- Where
- 1 siteEgypt
- Study dates
- 11 Dec 2021to 13 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 21 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Adult patients aged 21-60 years that underwent laparoscopic cholecystectomy with intra-operative difficult dissection due to adhesions or acute inflammation.
Who cannot join
- Patients who will refuse participation in the study
- Patients with bleeding disorders, clotting abnormalities, or on anticoagulants therapy.
- Easy going operation that do not necessitate drain insertion.
- major bleeding that could necessitate surgical intervention to control.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Effect of Local Instillation of Tranexamic Acid on the Gallbladder Bed After Laparoscopic Cholecystectomy to Decrease Possible Bleeding: Randomized Controlled Study.
Adult patients undergoing laparoscopic cholecystectomy are at high risk to develop postoperative bleeding especially in the presence of severe adhesions. Local instillation of the antifibrinolytic (tranexamic acid) at the gall bladder bed may decrease the risk of bleeding.
The aim of this study is to evaluate the role of topical administration of Tranexamic acid on gallbladder bed for prophylaxis against bleeding in cases of difficult dissection cases due to acute inflammation and dense adhesions.
Read the detailed description
This prospective study will be conducted in 80 adult patients admitted to surgery department Tanta University, the study will be carried out over 6 months after obtaining ethical committee approval, an informed written consent will be included.
Any unexpected risk that will appear during the procedure will be announced to the participants and ethical committee at time and adequate measures will be taken.
Risk to the patients There is known risk to the patient except for rare possible allergy to the drug.
All participant surgeons are experienced and familiar with the field. There will be adequate supervision to maintain the privacy of patients and confidentiality.
There will be no conflict of interest nor conflict with religion, law or society standards.
End point of study This study will be terminated if there is any unexpected risk from the drug.
This is a prospective study performed on 80 patients suffering from symptomatic cholelithiasis and will undergo laparoscopic cholecystectomy, they will be divided into two groups randomly by slip method. And will be performed by experienced surgeons.
All patients were subjected to:
Detailed history including drug intake (anticoagulants or antiplatelets) and thorough clinical examination.
laboratory investigations complete blood count (CBC), C-reactive protein (CRP), fasting blood sugar, renal function tests, and abdominal ultrasonography done.
Operative procedure After applying general anaesthesia , standard 4 port laparoscopic cholecystectomy will be performed. Patients in group A (40 patients) will receive 500 mg of Tranexamic acid dissolved in 20 ml normal saline locally in the liver bed after completing the procedure, we will introduce a piece of gauze to keep the drug in place for about 3 minutes and then remove it and we will insert a drain and close it for one hour after finishing the operation, if there is easy going operation without any adhesions and very minimal risk for bleeding it will be excluded.
For group B (40 patients) they will also undergo the same procedure with routine care that there is no significant bleeding then instillation of 20 ml normal saline locally in the liver bed and introduce a piece of gauze to keep the drug in place for about 3 minutes and then remove it and drain will be inserted for difficult cases and also easy ones will be excluded.
Post operative care Heart rate and blood pressure will be checked every 6 hours after surgery. Drain output will be recorded drain fluid hematocrit and hemoglobin will be investigated after 6 hours and 24 hours, and all the patients will be followed up till discharged. Drain will be removed if less than 50 cc for 24 hours.
Hb level will be performed after 48 h and was compared with the preoperative levels.
Any possible morbidity and time for ambulation and hospital stay will be recorded.
- Conditions
- Postoperative Complications
- Being tested
- Tranexamic Acid 500 MG, Normal saline
- Keywords
- gall bladder, postoperative bleeding, tranexamic acid
- Medical subject headings
- Postoperative Complications, Postoperative Hemorrhage
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Tranexamic Acid 500 MGDrug
Local instillation of 500 mg tranexamic acid in 20 ml normal saline in the gall bladder bed
Normal salineDrug
Local instillation of 20 ml normal saline in the gall bladder bed
| Study group | Role | What they receive |
|---|---|---|
| group A | Experimental | after careful hemostasis for the bleeding points in the liver bed received 500 mg of Tranexamic acid dissolved in 20 ml normal saline locally in the liver bed through the right port, then introduction of a piece of gauze to keep the drug in place for about 3 minutes and then remove it and inserting a drain and close it for one hour after finishing the operation. Receives: Drug: Tranexamic Acid 500 MG |
| group B | Experimental | they also underwent the same procedure with routine care for hemostasis until there was no significant bleeding and then instillation of 20 ml normal saline in the gallbladder bed , then drain was inserted and closed for 1 hour the sameway as group A. Receives: Drug: Normal saline |
What is being measured
The primary outcome is the main question the study is designed to answer.
Hematocrit concentration in the drain
The level of hematocrit in the drain 6 h after surgery
Measured: 6 hours
Secondary outcomes (2)
Hemoglobin level in the drain
The hemoglobin concentration in the drain 6 h after surgery
Measured: 6 hours
Length of hospital stay.
Time from admission to discharge of the patient
Measured: 24 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Feb 2024
- Study start11 Dec 2021
- Primary completion13 Dec 2022
- Study completion13 Dec 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Postoperative ComplicationsStudies 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Prospective study
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 91 participants (actual)
Sponsor and investigators
- Lead sponsor
- Tanta University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sameh Abdelkhalik Ahmed Ismaiel, Tanta University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06246422
- Sponsor's protocol ID
- TXA/08/2022
- Status last verified
- Feb 2025
- First submitted
- 30 Jan 2024
- Last updated
- 24 Feb 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: Once the study had been successfully completed, the data will be shared for other research
Study at a glance
From the registry record, last updated by the sponsor on 24 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Local Instillation of Tranexamic Acid on the Gallbladder Bed After Laparoscopic Cholecystectomy to Decrease Possible Bleeding: Randomized Controlled Study.
- ClinicalTrials.gov ID
- NCT06246422
- Acronym / sponsor ID
- TXA/08/2022
- Conditions
- Postoperative Complications
- Keywords
- gall bladder, postoperative bleeding, tranexamic acid
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 91 participants (actual)
- Lead sponsor
- Tanta UniversityUniversity, hospital or other
- Study start
- 11 Dec 2021 (actual)
- Primary completion
- 13 Dec 2022 (actual)
- Study completion
- 13 Dec 2022 (actual)
- First posted
- 7 Feb 2024 (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.
Adult patients undergoing laparoscopic cholecystectomy are at high risk to develop postoperative bleeding especially in the presence of severe adhesions. Local instillation of the antifibrinolytic (tranexamic acid) at the gall bladder bed may decrease the risk of bleeding.
The aim of this study is to evaluate the role of topical administration of Tranexamic acid on gallbladder bed for prophylaxis against bleeding in cases of difficult dissection cases due to acute inflammation and dense adhesions.
Detailed description
This prospective study will be conducted in 80 adult patients admitted to surgery department Tanta University, the study will be carried out over 6 months after obtaining ethical committee approval, an informed written consent will be included.
Any unexpected risk that will appear during the procedure will be announced to the participants and ethical committee at time and adequate measures will be taken.
Risk to the patients There is known risk to the patient except for rare possible allergy to the drug.
All participant surgeons are experienced and familiar with the field. There will be adequate supervision to maintain the privacy of patients and confidentiality.
There will be no conflict of interest nor conflict with religion, law or society standards.
End point of study This study will be terminated if there is any unexpected risk from the drug.
This is a prospective study performed on 80 patients suffering from symptomatic cholelithiasis and will undergo laparoscopic cholecystectomy, they will be divided into two groups randomly by slip method. And will be performed by experienced surgeons.
All patients were subjected to:
Detailed history including drug intake (anticoagulants or antiplatelets) and thorough clinical examination.
laboratory investigations complete blood count (CBC), C-reactive protein (CRP), fasting blood sugar, renal function tests, and abdominal ultrasonography done.
Operative procedure After applying general anaesthesia , standard 4 port laparoscopic cholecystectomy will be performed. Patients in group A (40 patients) will receive 500 mg of Tranexamic acid dissolved in 20 ml normal saline locally in the liver bed after completing the procedure, we will introduce a piece of gauze to keep the drug in place for about 3 minutes and then remove it and we will insert a drain and close it for one hour after finishing the operation, if there is easy going operation without any adhesions and very minimal risk for bleeding it will be excluded.
For group B (40 patients) they will also undergo the same procedure with routine care that there is no significant bleeding then instillation of 20 ml normal saline locally in the liver bed and introduce a piece of gauze to keep the drug in place for about 3 minutes and then remove it and drain will be inserted for difficult cases and also easy ones will be excluded.
Post operative care Heart rate and blood pressure will be checked every 6 hours after surgery. Drain output will be recorded drain fluid hematocrit and hemoglobin will be investigated after 6 hours and 24 hours, and all the patients will be followed up till discharged. Drain will be removed if less than 50 cc for 24 hours.
Hb level will be performed after 48 h and was compared with the preoperative levels.
Any possible morbidity and time for ambulation and hospital stay will be recorded.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- Prospective study
| Arm | Type | Receives |
|---|---|---|
| group A | Experimental | Drug: Tranexamic Acid 500 MGafter careful hemostasis for the bleeding points in the liver bed received 500 mg of Tranexamic acid dissolved in 20 ml normal saline locally in the liver bed through the right port, then introduction of a piece of gauze to keep the drug in place for about 3 minutes and then remove it and inserting a drain and close it for one hour after finishing the operation. |
| group B | Experimental | Drug: Normal salinethey also underwent the same procedure with routine care for hemostasis until there was no significant bleeding and then instillation of 20 ml normal saline in the gallbladder bed , then drain was inserted and closed for 1 hour the sameway as group A. |
Who may qualify
- Ages
- 21 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- Adult patients aged 21-60 years that underwent laparoscopic cholecystectomy with intra-operative difficult dissection due to adhesions or acute inflammation.
Key exclusion criteria (4 listed)
- Patients who will refuse participation in the study
- Patients with bleeding disorders, clotting abnormalities, or on anticoagulants therapy.
- Easy going operation that do not necessitate drain insertion.
- major bleeding that could necessitate surgical intervention to control.
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 |
|---|---|---|
| Tranexamic Acid 500 MGLocal instillation of 500 mg tranexamic acid in 20 ml normal saline in the gall bladder bed | Drug | group A |
| Normal salineLocal instillation of 20 ml normal saline in the gall bladder bed | Drug | group B |
Primary outcome
Hematocrit concentration in the drain
Time frame: 6 hours
The level of hematocrit in the drain 6 h after surgery
2 secondary outcomes
Hemoglobin level in the drain
Time frame: 6 hours
Length of hospital stay.
Time frame: 24 hours
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 24 Feb 2025.
- Individual participant dataSharing planned: Undecided. Once the study had been successfully completed, the data will be shared for other 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 Tranexamic Acid 500 MG and Normal saline in people with Postoperative Complications, run by Tanta University at 1 site in Egypt.
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 1 inclusion and 4 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 24 Feb 2025. 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 Egypt. 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?
Hematocrit concentration in the drain (time frame: 6 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 24 Feb 2025.