- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07088575
- Original Trial
Practice of Deep Venous Thrombosis Prophylaxis and Its Incidence in Patients Undergoing Gastrointestinal and Hepatobiliary Surgery
July 19, 2025 updated by: Prajjwol Luitel, Maharajgunj Medical Campus
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Observational
Enrollment (Actual)
1530
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
-
Kathmandu, Nepal
- Maharajgunj Medical Campus
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
No
Sampling Method
Non-Probability Sample
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
Description
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
|
Patients >18 years who underwent major gastrointestinal or hepatobiliary surgery
|
major gastrointestinal or hepatobiliary surgery under general anesthesia
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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.
|
From date of surgery until hospital discharge or up to 30 days postoperatively, whichever occurs first
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Prajjwol Luitel, MBBS, Maharajgunj Medical Campus
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
May 23, 2024
Primary Completion (Actual)
July 21, 2024
Study Completion (Actual)
July 24, 2024
Study Registration Dates
First Submitted
July 19, 2025
First Submitted That Met QC Criteria
July 19, 2025
First Posted (Actual)
July 28, 2025
Study Record Updates
Last Update Posted (Actual)
July 28, 2025
Last Update Submitted That Met QC Criteria
July 19, 2025
Last Verified
July 1, 2025
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 589(6-11)E2.079/080
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
YES
IPD Plan Description
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.
IPD Sharing Time Frame
The IPD and supporting documents will be available beginning six months after publication of the study results and will remain available for up to five years thereafter.
IPD Sharing Access Criteria
Access will be granted to qualified researchers and institutions conducting ethically approved research.
Requests must include a brief study proposal and intended use.
Data will be made available through a secure data-sharing platform upon signing a data use agreement.
IPD Sharing Supporting Information Type
- SAP
- ANALYTIC_CODE
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Gastrointestinal
-
Medstar Health Research InstituteRecruitingGastrointestinal Cancer | Gastrointestinal Tumor | Gastrointestinal Surgery | Gastrointestinal Tumor SurgeryUnited States
-
Pancap Pharma Inc.Nutrasource Pharmaceutical and Nutraceutical Services, Inc.CompletedHealthy | Gastrointestinal Digestion | Gastrointestinal Wellbeing | Gastrointestinal SupplementsCanada
-
Umeå UniversityCompletedFunctional Gastrointestinal DisorderSweden
-
The University of Texas Medical Branch, GalvestonCompletedGastrointestinal Disorders, Functional
-
Campus Bio-Medico UniversityRecruitingGastrointestinal Cancer | Gastrointestinal Hemorrhage | Gastrointestinal Lesions | Gastrointestinal Injury | Gastrointestinal Perforation | Gastrointestinal UlcerItaly
-
Fondazione Don Carlo Gnocchi OnlusCatholic University of the Sacred Heart; University of PadovaRecruitingFunctional Gastrointestinal Disorders (FGIDs)Italy
-
Chang Gung Memorial HospitalNew Bellus EnterprisesUnknownNeoplasm | Functional Gastrointestinal DisorderTaiwan
-
Dr Anne PayneUniversity of LondonUnknownFunctional Gastrointestinal Disorders in ChildrenUnited Kingdom
-
Massachusetts General HospitalEnrolling by invitationGastrointestinal Dysfunction | Gastrointestinal DiseaseUnited States
-
AstraZenecaJohnson & Johnson K.K. Medical CompanyCompletedGastrointestinal Endoscopy | Gastrointestinal PolypectomyJapan
Clinical Trials on major gastrointestinal or hepatobiliary surgery under general anesthesia
-
Ankara Etlik City HospitalRecruitingPain Management | Deep Brain Stimulation | Regional Anesthesia | Parkinsons DiseaseTurkey (Türkiye)
-
Institute for Clinical Effectiveness, JapanNadogaya HospitalNot yet recruitingIdiopathic Normal Pressure Hydrocephalus (INPH)Japan
-
Huashan HospitalCompletedBrain Neoplasms | Surgery | HyperemiaChina
-
AZ Sint-Jan AVUnknownInflammation | Postoperative PainBelgium
-
Hôpital Armand TrousseauRecruitingInfant | General AnesthesiaFrance
-
University Hospital, BordeauxCompleted
-
University of PecsRecruitingPostoperative Pain | Arm InjuryHungary
-
Shengjing HospitalCompletedPostoperative Pain | Preoperative Anxiety | General Anesthesia | Postoperative Sleep QualityChina
-
Kern Medical CenterCompletedCOVID-19 | Postoperative Complications | Surgical OutcomesUnited States
-
Makassed General HospitalRecruitingMajor Abdominal SurgeryLebanon