Intra-abdominal Hypertension and Abdominal Compartment Syndrome in Patients After Pancreatic Procedures.

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

Status

Not yet recruiting

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT06672601

Acronym

HYPA

Enrollment

150

Registered

2024-11-04

Start date

2025-01-01

Completion date

2028-03-31

Last updated

2024-11-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Abdominal Compartment Syndrome, Anastomotic Leaks, Delayed Gastric Emptying, Intra Abdominal Pressure, Overload Fluid, Pancreatic Fistula After Pancreaticoduodenectomy, Pancreatic Surgery

Keywords

Intra-abdominal hypertension, Compartment syndrome, Pancreatic surgery, Robotic surgery

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

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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.

Design outcomes

Primary

Measure	Time frame	Description
Prevalence of Intra-abdominal hypertension and abdominal compartment syndrome	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

Measure	Time frame	Description
Correlation between intra-abdominal hypertension and the development of postoperative complications.	From the enrollment to the 90 days follow up period.	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.

Other

Measure	Time frame	Description
Incidence of Intra-abdominal hypertension in patients following robotic vs. open pancreatic procedure.	From the admission to the intensive care unit for 7 consecutive days or until discharge from the ICU.	The tertiary objective is to compare open and robotic pancreatic procedures in terms of incidence of intra-abdominal hypertension and ACS

Countries

Czechia

Contacts

Primary ContactŠtěpán-Ota Schütz, MD.

stepan.sch@gmail.com00420 733224640

Outcome results