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

G

Govind Ballabh Pant Hospital

Status

Unknown

Conditions

Periampullary Carcinoma

Treatments

Procedure: pancreaticoduodenectomy

Study type

Interventional

Funder types

Other

Identifiers

NCT03722732
F.1/IEC/MAMC/63/03/18/NO325

Details and patient eligibility

About

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

Full 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.

Enrollment

36 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Double Blind

36 participants in 2 patient groups

Open pancreaticoduedenectomy
Active Comparator group
Description:
will include all the patients who will undergo open pancreaticoduodenectomy
Treatment:
Procedure: pancreaticoduodenectomy
Laparoscopic pancreaticoduodenectomy
Active Comparator group
Description:
will include all the patients undergoing laparoscopic pancreaticoduodenectomy
Treatment:
Procedure: pancreaticoduodenectomy

Trial contacts and locations

1

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Central trial contact

Aditya sharma, MCH resident; H H Nag, MS

Data sourced from clinicaltrials.gov

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