Practice of Deep Venous Thrombosis Prophylaxis and Its Incidence in Patients Undergoing Gastrointestinal and Hepatobiliary Surgery

NCT07088575 | Completed

• 1 other identifier: 589(6-11)E2.079/080
• Study Type: observational
• Target: 1,530
• Locations: 1 country
• Sites: 1

Brief 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. This study aims to evaluate current thromboprophylaxis practices and determine the incidence of DVT in Nepalese adults undergoing gastrointestinal and hepatobiliary surgery.

Conditions

Gastrointestinal

Outcome Measures

Primary Outcomes (1)

• 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.

  From date of surgery until hospital discharge or up to 30 days postoperatively, whichever occurs first

Study Arms (1)

Patients >18 years who underwent major gastrointestinal or hepatobiliary surgery

Procedure: major gastrointestinal or hepatobiliary surgery under general anesthesia

Interventions

major gastrointestinal or hepatobiliary surgery under general anesthesia PROCEDURE

major gastrointestinal or hepatobiliary surgery under general anesthesia

Patients >18 years who underwent major gastrointestinal or hepatobiliary surgery

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Maharajgunj Medical Campus: lead

Study Sites (1)

Maharajgunj Medical Campus

Kathmandu, Nepal

Location

Study Officials

• Prajjwol Luitel, MBBS

  Maharajgunj Medical Campus

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: July 19, 2025
• First Posted: July 28, 2025
• Study Start: May 23, 2024
• Primary Completion: July 21, 2024
• Study Completion: July 24, 2024
• Last Updated: July 28, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will share
• Shared Documents: SAP, ANALYTIC CODE
• 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.
• 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.

Locations

NE (1)