GastrointestinalNCT07088575
Practice of Deep Venous Thrombosis Prophylaxis and Its Incidence in Patients Undergoing Gastrointestinal and Hepatobiliary Surgery
An observational study of Gastrointestinal, run by Maharajgunj Medical Campus at 1 site in Nepal.
Trial summary
Recent studies from Asia have reported a wide variation in the incidence of deep vein thrombosis (DVT), ranging from 5% to 50% in patients undergoing major abdominal surgery. However, data specific to the Nepalese population remains unavailable. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Gastrointestinal
- What is being tested?
- major gastrointestinal or hepatobiliary surgery under general anesthesia
- Type of treatment
- Surgery or procedure
- How many people
- 1,530 participants
- Where
- 1 siteNepal
- Study dates
- 23 May 2024to 24 Jul 2024
- Phase
- Observational
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: The study population consisted of adult patients aged >18 years who underwent major gastrointestinal or hepatobiliary surgery under general anesthesia at a tertiary referral center in Nepal. Patients were identified retrospectively through departmental audit records from the Department of Surgical Gastroenterology between October 2021 and April 2024. Major surgery was defined as any operative intervention involving the abdominal or hepatobiliary region requiring general anesthesia. Surgical procedures were categorized by organ system into upper gastrointestinal, hepatopancreatobiliary (HPB), colorectal, and other (e.g., small intestine, retroperitoneum, abdominal wall). Patients with a recent history of venous thromboembolism (VTE), known hypercoagulable conditions, atrial fibrillation, ongoing cancer therapy, pregnancy, or incomplete clinical data were excluded from the study. Data collected included demographic, clinical, intraoperative, and postoperative variables relevant to thromb
Who may be able to join
- Adults aged >18 years
- Underwent major gastrointestinal or hepatobiliary surgery
- Surgery performed under general anesthesia
- Major surgery defined as any operative intervention in the abdominal or hepatobiliary region requiring general anesthesia
Who cannot join
- History of VTE within 3 months before surgery
- Known hypercoagulable state or congenital thrombophilia
- Diagnosis of atrial fibrillation
- Undergoing systemic cancer chemotherapy or radiotherapy within the past 15 days
- Pregnant or lactating women
- Missing information in clinical records
- Non-operated patients or those receiving conservative management
- Patients undergoing liver transplantation
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Practice of Deep Venous Thrombosis Prophylaxis and Its Incidence in Patients Undergoing Gastrointestinal and Hepatobiliary Surgery: A Nepalese Single-center, Retrospective Study
Recent studies from Asia have reported a wide variation in the incidence of deep vein thrombosis (DVT), ranging from 5% to 50% in patients undergoing major abdominal surgery. However, data specific to the Nepalese population remains unavailable. This study aims to evaluate current thromboprophylaxis practices and determine the incidence of DVT in Nepalese adults undergoing gastrointestinal and hepatobiliary surgery.
- Conditions
- Gastrointestinal
- Being tested
- major gastrointestinal or hepatobiliary surgery under general anesthesia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
major gastrointestinal or hepatobiliary surgery under general anesthesiaProcedure or surgery
major gastrointestinal or hepatobiliary surgery under general anesthesia
| Study group | Role | What they receive |
|---|---|---|
| Patients >18 years who underwent major gastrointestinal or hepatobiliary surgery | Not described Receives: Procedure: major gastrointestinal or hepatobiliary surgery under general anesthesia |
What is being measured
The primary outcome is the main question the study is designed to answer.
Use of Thromboprophylaxis and Incidence of DVT in Major GI and Hepatobiliary Surgeries
This outcome assesses the proportion of patients receiving appropriate thromboprophylaxis, as well as the incidence of deep vein thrombosis (DVT) among individuals undergoing major gastrointestinal and hepatobiliary surgeries. Data will be collected to evaluate adherence to prophylaxis guidelines and to determine the effectiveness of thromboprophylactic measures in preventing DVT in this surgical population.
Measured: From date of surgery until hospital discharge or up to 30 days postoperatively, whichever occurs first
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jul 2025
- Study start23 May 2024
- Primary completion21 Jul 2024
- Study completion24 Jul 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for GastrointestinalStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 1,530 participants (actual)
Sponsor and investigators
- Lead sponsor
- Maharajgunj Medical Campus
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Prajjwol Luitel, Maharajgunj Medical Campus
- Investigators
- Prajjwol Luitel, MBBS, Principal investigator, Maharajgunj Medical Campus
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07088575
- Sponsor's protocol ID
- 589(6-11)E2.079/080
- Status last verified
- Jul 2025
- First submitted
- 19 Jul 2025
- Last updated
- 28 Jul 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: De-identified individual participant data (IPD) related to demographic characteristics, surgical details, thromboprophylaxis use, and DVT outcomes will be shared. This includes preoperative, intraoperative, and postoperative variables as collected in the study.
Study at a glance
From the registry record, last updated by the sponsor on 28 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Practice of Deep Venous Thrombosis Prophylaxis and Its Incidence in Patients Undergoing Gastrointestinal and Hepatobiliary Surgery: A Nepalese Single-center, Retrospective Study
- ClinicalTrials.gov ID
- NCT07088575
- Acronym / sponsor ID
- 589(6-11)E2.079/080
- Conditions
- Gastrointestinal
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 1,530 participants (actual)
- Lead sponsor
- Maharajgunj Medical CampusUniversity, hospital or other
- Study start
- 23 May 2024 (actual)
- Primary completion
- 21 Jul 2024 (actual)
- Study completion
- 24 Jul 2024 (actual)
- First posted
- 28 Jul 2025 (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.
Recent studies from Asia have reported a wide variation in the incidence of deep vein thrombosis (DVT), ranging from 5% to 50% in patients undergoing major abdominal surgery. However, data specific to the Nepalese population remains unavailable. This study aims to evaluate current thromboprophylaxis practices and determine the incidence of DVT in Nepalese adults undergoing gastrointestinal and hepatobiliary surgery.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients >18 years who underwent major gastrointestinal or hepatobiliary surgery | – | Procedure: major gastrointestinal or hepatobiliary surgery under general anesthesia |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- The study population consisted of adult patients aged >18 years who underwent major gastrointestinal or hepatobiliary surgery under general anesthesia at a tertiary referral center in Nepal. Patients were identified retrospectively through departmental audit records from the Department of Surgical Gastroenterology between October 2021 and April 2024. Major surgery was defined as any operative intervention involving the abdominal or hepatobiliary region requiring general anesthesia. Surgical procedures were categorized by organ system into upper gastrointestinal, hepatopancreatobiliary (HPB), colorectal, and other (e.g., small intestine, retroperitoneum, abdominal wall). Patients with a recent history of venous thromboembolism (VTE), known hypercoagulable conditions, atrial fibrillation, ongoing cancer therapy, pregnancy, or incomplete clinical data were excluded from the study. Data collected included demographic, clinical, intraoperative, and postoperative variables relevant to thromb
Key inclusion criteria (4 listed)
- Adults aged >18 years
- Underwent major gastrointestinal or hepatobiliary surgery
- Surgery performed under general anesthesia
- Major surgery defined as any operative intervention in the abdominal or hepatobiliary region requiring general anesthesia
Key exclusion criteria (8 listed)
- History of VTE within 3 months before surgery
- Known hypercoagulable state or congenital thrombophilia
- Diagnosis of atrial fibrillation
- Undergoing systemic cancer chemotherapy or radiotherapy within the past 15 days
- Pregnant or lactating women
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 |
|---|---|---|
| major gastrointestinal or hepatobiliary surgery under general anesthesiamajor gastrointestinal or hepatobiliary surgery under general anesthesia | Procedure or surgery | Patients >18 years who underwent major gastrointestinal or hepatobiliary surgery |
Primary outcome
Use of Thromboprophylaxis and Incidence of DVT in Major GI and Hepatobiliary Surgeries
Time frame: From date of surgery until hospital discharge or up to 30 days postoperatively, whichever occurs first
This outcome assesses the proportion of patients receiving appropriate thromboprophylaxis, as well as the incidence of deep vein thrombosis (DVT) among individuals undergoing major gastrointestinal and hepatobiliary surgeries. Data will be collected to evaluate adherence to prophylaxis guidelines and to determine the effectiveness of thromboprophylactic measures in preventing DVT in this surgical population.
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 28 Jul 2025.
- Individual participant dataSharing planned: Yes. De-identified individual participant data (IPD) related to demographic characteristics, surgical details, thromboprophylaxis use, and DVT outcomes will be shared. This includes preoperative, intraoperative, and postoperative variables as collected in the study.
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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.
Prajjwol Luitel, MBBS principal investigator
Maharajgunj Medical Campus
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Gastrointestinal, run by Maharajgunj Medical Campus at 1 site in Nepal.
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 4 inclusion and 8 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 28 Jul 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 Nepal. 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?
Use of Thromboprophylaxis and Incidence of DVT in Major GI and Hepatobiliary Surgeries (time frame: From date of surgery until hospital discharge or up to 30 days postoperatively, whichever occurs first). 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 28 Jul 2025; AzTrials last refreshed its copy on 7 Nov 2026.