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NCT Number: NCT06672601

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

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.

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Key information

Conditions

Intra Abdominal Pressure Abdominal Compartment Syndrome Anastomotic Leak Anastomotic Leaks Cardiovascular Diseases Compartment Syndromes Delayed Gastric Emptying Digestive System Diseases Edema Gastrointestinal Diseases Gastroparesis Intra-Abdominal Hypertension Muscular Diseases Musculoskeletal Diseases Neurologic Manifestations Overload Fluid Pancreatic Fistula After Pancreaticoduodenectomy Pancreatic Surgery Paralysis Pathologic Processes Pathological Conditions, Signs and Symptoms Postoperative Complications Signs and Symptoms Stomach Diseases Vascular Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Department of Surgery 2nd Faculty of Medicine, Charles University and Military University Hospital Prague

Prague, Prague 6, 169 02, Czechia

Location contact

Štěpán-Ota Schütz, MD

CONTACT

[email protected]

00 420 733 224 640

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Primary outcomes

  1. 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

  1. Correlation between intra-abdominal hypertension and the development of postoperative complications.

    Time frame: 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 outcomes

  1. Incidence of Intra-abdominal hypertension in patients following robotic vs. open pancreatic procedure.

    Time frame: 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

Study contacts

Contact information is provided by the study sponsor or research team.

Štěpán-Ota Schütz, MD.

CONTACT

[email protected]

00420 733224640

Sponsors and collaborators

Lead sponsor

Charles University, Czech Republic

Other

Collaborators

  • Military University Hospital, Prague

Registry information

Official study title

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

Acronym: HYPA

Important dates

Study start
2025
Primary completion
2027
Study completion
2028
First posted
Nov 4, 2024
Registry last updated
Nov 8, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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