Clinical Impact of Altitude Level on Surgical Outcomes of Pancreaticoduodenectomy

Study Overview
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Brief Summary
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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
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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

Official Title
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Clinical Impact of Altitude Level on Surgical Outcomes of Pancreaticoduodenectomy for Periampullary Tumour (Multicenter Study)

Conditions
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Periampullary Cancer

Intervention / Treatment
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* Procedure: PANCREATICODUDENECTOMY


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: periampulary tumour Exclusion Criteria: liver cirrhosis, PG, advanced tumour, vascular resection
Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: it is a multicenter study Aseer centeral hospital, saudia and from Egypt two centers mansoura university and el menia university The patients distributed into two groups group I (G1) PD underwent in the area at the level of the sea, normal altitude region, and group II (G2) PD underwent in high altitude region.
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: PD in normal altitude<br>PD underwent in the area at the level of the sea, normal altitude region | Procedure: PANCREATICODUDENECTOMY<br>* dissection and removal of periampulary tumour with 3 reconstruction PJ, HJ, and GJ<br>* Other names: Whippl,s operation;|
| Active Comparator: PD in high altitude region.<br>PD underwent in high altitude region. | Procedure: PANCREATICODUDENECTOMY<br>* dissection and removal of periampulary tumour with 3 reconstruction PJ, HJ, and GJ<br>* Other names: Whippl,s operation;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| the overall postoperative complications | the overall postoperative complications | 30 DAYS | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| blood loss | blood loss | INTRAOPERATIVE | 
| Pulmonary embolism (PE) | Pulmonary embolism (PE) | 30 days | 
| hospital mortality | death within 30 days of operation | 30 days | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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pancreaticodudenctomy, POPF, HIGH ALTITUDE