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

Not yet recruiting

• Conditions: Intra Abdominal Pressure; Abdominal Compartment Syndrome; Pancreatic Surgery; Pancreatic Fistula After Pancreaticoduodenectomy; Delayed Gastric Emptying; Anastomotic Leaks; Overload Fluid

• Registration Number: NCT06672601
• Lead Sponsor: Charles University, Czech Republic

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 Timeline

• Status Verified: 2024-11
• Study First Submitted: 2024-11-01
• Study First Submitted QC: 2024-11-01
• Study First Posted: 2024-11-04
• Last Update Submitted: 2024-11-07
• Last Update Posted: 2024-11-08
• Study Start: 2025-01-01
• Primary Completion: 2027-12-31
• Study Completion: 2028-03-31

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 150

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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.

Trial Locations

Locations (1)

Department of Surgery 2nd Faculty of Medicine, Charles University and Military University Hospital Prague; 🇨🇿 Prague, Prague 6, Czechia