Clinical trial NCT04401722: Clinical Impact of Altitude Level on Surgical Outcomes of Pancreaticoduodenectomy
Official title: Clinical Impact of Altitude Level on Surgical Outcomes of Pancreaticoduodenectomy for Periampullary Tumour (Multicenter Study)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Periampullary Cancer
Keywords: pancreaticodudenctomy
POPF
HIGH ALTITUDE
Lead sponsor: Mansoura University
Sponsor class: OTHER
First posted: 2020-05-26
Enrollment: 90
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Intervention 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.
Primary purpose: TREATMENT

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

Eligibility criteria: Inclusion Criteria:

* periampulary tumour

Exclusion Criteria:

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

Primary outcomes:
measure: the overall postoperative complications
timeFrame: 30 DAYS
Secondary outcomes:
measure: blood loss
timeFrame: INTRAOPERATIVE
measure: Pulmonary embolism (PE)
timeFrame: 30 days
measure: hospital mortality
timeFrame: 30 days
Other outcomes:
Locations:
city: Mansoura
country: Egypt
facility: Mahmoud Abd El Wahab
Study officials:
affiliation: Mansoura University, Gastrointestinal Surgery Center
name: Ayman E Nakeeb, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Dutta V, Singh R, Kumar S, Aggarwal N, Hari Kumar KVS. Profile of pulmonary embolism in service personnel posted at high altitude area. Indian Heart J. 2018 May-Jun;70(3):427-429. doi: 10.1016/j.ihj.2017.08.002. Epub 2017 Aug 18.
citation: El Nakeeb A, Attia M, El Sorogy M, Ezzat H, Shehta A, Salem A, El Gawad MA, Hamed H, Allah TA, El-Geidi AA, Fathy O, El Hefnawy E, Zaghloul A. Laparoscopic Pancreaticodudenectomy for Periampullary Tumor: Should it be a Routine? A Propensity Score-matched Study. Surg Laparosc Endosc Percutan Tech. 2020 Feb;30(1):7-13. doi: 10.1097/SLE.0000000000000715.
citation: El Nakeeb A, El Sorogy M, Hamed H, Said R, Elrefai M, Ezzat H, Askar W, Elsabbagh AM. Biliary leakage following pancreaticoduodenectomy: Prevalence, risk factors and management. Hepatobiliary Pancreat Dis Int. 2019 Feb;18(1):67-72. doi: 10.1016/j.hbpd.2018.10.005. Epub 2018 Oct 28.
citation: Prabhakar A, Chatterjee T, Bajaj N, Tyagi T, Sahu A, Gupta N, Kumari B, Nair V, Kumar B, Ashraf MZ. Venous thrombosis at altitude presents with distinct biochemical profiles: a comparative study from the Himalayas to the plains. Blood Adv. 2019 Nov 26;3(22):3713-3723. doi: 10.1182/bloodadvances.2018024554.