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Clinical Trials/NCT06672601
NCT06672601Not yet recruitingNot Applicable

The HYPA Study: Intra-abdominal Hypertension and Abdominal Compartment Syndrome in Patients Undergoing Open and Robotic Pancreatic Procedures

Charles University, Czech Republic1 site in 1 country150 target enrollmentStarted: January 1, 2025Last updated:
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Conditions

Trial Snapshot

Phase
Not Applicable
Status
Not yet recruiting
Sponsor
Enrollment
150
Locations
1
Primary Endpoint
Prevalence of Intra-abdominal hypertension and abdominal compartment syndrome
Study OverviewStudy DesignEligibility CriteriaOutcomesInvestigatorsSitesRecords & IdentifiersSimilar Trials

Study Overview

Brief Summary

This study investigates the development of intra-abdominal hypertension and compartment syndrome in patients undergoing elective pancreatic procedures. Main objective is to determine the proportion of patients after pancreatic operation who develop elevated intra-abdominal pressure and assess its association with postoperative complication rates. Another goal of the study is to compare open versus robotic pancreatic procedures regarding the occurrence of intra-abdominal hypertension and abdominal compartment syndrome.

Detailed Description

HYPA study is designed as a prospective observational study. The primary objective of this study is to assess the risk and prevalence of intra-abdominal hypertension and abdominal compartment syndrome following pancreatic procedures. The secondary objective aims to explore potential correlations between intra-abdominal hypertension and the development of postoperative complications, such as anastomotic dehiscence, postoperative pancreatic fistulas, prolonged postoperative ileus, or delayed gastric emptying. The third objective is to compare the incidence of intra-abdominal hypertension in patients undergoing robotic versus open pancreatic procedures

Study Design

Study Type
Observational
Observational Model
Cohort
Time Perspective
Prospective

Eligibility Criteria

Ages
18 Years to — (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

Inclusion Criteria

  • •Patients ≥ 18-year-old
  • •Indication for elective pancreatic procedure
  • •Written informed consent

Exclusion Criteria

  • •Patients <18 years old.
  • •Contraindication for urinary catheter placement.
  • •Refusal to participate in the study.

Outcomes

Primary Outcomes

Prevalence of Intra-abdominal hypertension and abdominal compartment syndrome

Time Frame: From the admission to the intensive care unit until the postoperative day 7 or until discharge from the ICU

Prevalence of intra-abdominal hypertension and abdominal compartment syndrome in patients following pancreatic procedures.

Secondary Outcomes

  • Correlation between intra-abdominal hypertension and the development of postoperative complications.(From the enrollment to the 90 days follow up period.)

Investigators

Sponsor
Charles University, Czech Republic
Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Štěpán-Ota Schütz

Surgical resident, Postgraduate student

Charles University, Czech Republic

Study Sites (1)

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