Clinical Impact of Altitude Level on Surgical Outcomes of Pancreaticoduodenectomy

Not Applicable

Completed

• Conditions: Periampullary Cancer
• Interventions: Procedure: PANCREATICODUDENECTOMY

• Registration Number: NCT04401722
• Lead Sponsor: Mansoura University

Brief Summary

Very few papers examine the effect of living at high altitudes on surgical results of major operations. This research is designed to determine the surgical outcomes of PD for periampullary tumour in high altitudes and normal altitudes.

Detailed Description

Many recent studies have suggested multiple risk factors affecting postoperative surgical outcomes of PD; THE research is designed to determine the surgical outcomes of PD for periampullary tumour in high altitudes and normal altitude.

it is a multicenter study Aseer central hospital, Saudia and from Egypt two centers Mansoura university and el Menia university

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study Start: 2018-03-01
• Primary Completion: 2020-04-01
• Study Completion: 2020-04-25
• Study First Submitted: 2020-05-21
• Study First Submitted QC: 2020-05-22
• Study First Posted: 2020-05-26
• Status Verified: 2020-06
• Last Update Submitted: 2020-06-06
• Last Update Posted: 2020-06-09

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 90

Inclusion Criteria

• periampulary tumour

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Exclusion Criteria

• liver cirrhosis,
• PG,
• advanced tumour,
• vascular resection

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
PD in normal altitude	PANCREATICODUDENECTOMY	PD underwent in the area at the level of the sea, normal altitude region
PD in high altitude region.	PANCREATICODUDENECTOMY	PD underwent in high altitude region.

Primary Outcome Measures

Name	Time	Method
the overall postoperative complications	30 DAYS	the overall postoperative complications

Secondary Outcome Measures

Name	Time	Method
hospital mortality	30 days	death within 30 days of operation
blood loss	INTRAOPERATIVE	blood loss
Pulmonary embolism (PE)	30 days	Pulmonary embolism (PE)

Trial Locations

Locations (1)

Mahmoud Abd El Wahab; 🇪🇬 Mansoura, Egypt