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

Not Applicable

• Conditions: Periampullary Carcinoma

• Registration Number: NCT03722732
• Lead Sponsor: Govind Ballabh Pant Hospital

Brief Summary

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

Detailed 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.

Study Timeline

• Study Start: 2018-09-11
• Study First Submitted: 2018-10-02
• Study First Submitted QC: 2018-10-25
• Study First Posted: 2018-10-29
• Status Verified: 2021-07
• Last Update Submitted: 2021-07-30
• Last Update Posted: 2021-08-02
• Primary Completion: 2022-12
• Study Completion: 2023-03

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 36

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
intraoperative blood loss in ml, quantitative	24 hours	blood loss will be assessed with the help of a formula which uses preoperative and post operative hematocrit, blood volume and PCV

Trial Locations

Locations (1)

G B Pant Hospital; 🇮🇳 New Delhi, Delhi, India