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NCT03722732 Clinical Trial

Comparison of Blood Loss in Laparoscopic vs Open Pancreaticoduodenectomy in Patients With Periampullary Carcinoma

Periampullary Carcinoma Clinical Trial

Official title:
Comparison of Blood Loss in Laparoscopic vs Open Pancreaticoduodenectomy in Patients With Periampullary Carcinoma - A Randomized Clinical Trial

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT03722732
Other study ID # F.1/IEC/MAMC/63/03/18/NO325
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date September 11, 2018
Est. completion date March 2023

Study information
Verified date July 2021
Source Govind Ballabh Pant Hospital
Contact H H Nag, MS
Phone 9718599260
Email hirdayanag@gmail.com
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

the study is designed to compare the blood loss between laparoscopic vs open pancreaticoduodenectomy in a randomized clinical trial

Description:

the study will assess the difference in the amount of blood loss in Lap vs Open WPD. the amount of blood loss will be calculated on the basis of a formula which takes pre operative and post operative hematocrit, PCV and blood volume into consideration.

Recruitment information / eligibility
Status Recruiting
Enrollment 36
Est. completion date March 2023
Est. primary completion date December 2022
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: 1. Patients of both the sex aged between >18 years. 2. Patients with a diagnosis of resectable periampullary carcinoma on imaging. 3. Patients with ASA grade 1 or 2 Exclusion Criteria: - 1) Patients found to have unresectable disease on radiological investigation. 2) Patients with ASA grade 3 or above

Study Design

Related Conditions & MeSH terms

Intervention

Procedure:
• pancreaticoduodenectomy
pancreaticoduodenectomy either laparoscopically or open will be done

Locations
Country Name City State
India G B Pant Hospital New Delhi Delhi

Sponsors (1)
Lead Sponsor Collaborator
Govind Ballabh Pant Hospital

Country where clinical trial is conducted

India, 

Outcome
Type Measure Description Time frame Safety issue
Primary intraoperative blood loss in ml, quantitative blood loss will be assessed with the help of a formula which uses preoperative and post operative hematocrit, blood volume and PCV 24 hours
See also
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Recruiting NCT05660915 - A Prospective Clinical Study Using an Artery-first Intermediate Approach in Robot-assisted Pancreaticoduodenectomy N/A
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Not yet recruiting NCT01931449 - Evaluation of A New Digestive Reconstruction Procedure Following Pancreatoduodenectomy Phase 3
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