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

NCT ID: NCT03722732

Last Updated: 2021-08-02

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

36 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-09-11

Study Completion Date

2023-03-31

Brief Summary

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

Detailed Description

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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.

Conditions

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Periampullary Carcinoma

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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Open pancreaticoduedenectomy

will include all the patients who will undergo open pancreaticoduodenectomy

Group Type ACTIVE_COMPARATOR

pancreaticoduodenectomy

Intervention Type PROCEDURE

pancreaticoduodenectomy either laparoscopically or open will be done

Laparoscopic pancreaticoduodenectomy

will include all the patients undergoing laparoscopic pancreaticoduodenectomy

Group Type ACTIVE_COMPARATOR

pancreaticoduodenectomy

Intervention Type PROCEDURE

pancreaticoduodenectomy either laparoscopically or open will be done

Interventions

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pancreaticoduodenectomy

pancreaticoduodenectomy either laparoscopically or open will be done

Intervention Type PROCEDURE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Govind Ballabh Pant Hospital

OTHER_GOV

Sponsor Role lead

Responsible Party

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Hirdaya H Nag, MS

Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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H H Nag, MS

Role: PRINCIPAL_INVESTIGATOR

GBPant Hospital

Locations

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G B Pant Hospital

New Delhi, National Capital Territory of Delhi, India

Site Status RECRUITING

Countries

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India

Central Contacts

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H H Nag, MS

Role: CONTACT

9718599260

Aditya sharma, MCH resident

Role: CONTACT

9718599258

Facility Contacts

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hirdaya h nag, ms

Role: primary

91 11 23234242 ext. 5220

Other Identifiers

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F.1/IEC/MAMC/63/03/18/NO325

Identifier Type: -

Identifier Source: org_study_id

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