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

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

Study Overview

• Status: Not yet recruiting
• Conditions: Delayed Gastric Emptying; Pancreatic Fistula After Pancreaticoduodenectomy; Pancreatic Surgery; Abdominal Compartment Syndrome; Intra Abdominal Pressure; Anastomotic Leaks; Overload Fluid

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 Type: Observational
• Enrollment (Estimated): 150

Contacts and Locations

• Study Contact: Name: Štěpán-Ota Schütz, MD.; Phone Number: 00420 733224640; Email: stepan.sch@gmail.com

Study Locations

• Czechia
  • Prague 6
    • Prague, Prague 6, Czechia, 169 02
      • Department of Surgery 2nd Faculty of Medicine, Charles University and Military University Hospital Prague
      • Contact: Štěpán-Ota Schütz, MD; Phone Number: 00 420 733 224 640; Email: schutz.stepan-ota@uvn.cz

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

All patients undergoing open or robotic pancreatic procedures in our department.

Description

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 Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort
Patients after pancreatic procedures; All patients following pancreatic procedure

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Prevalence of Intra-abdominal hypertension and abdominal compartment syndrome	Prevalence of intra-abdominal hypertension and abdominal compartment syndrome in patients following pancreatic procedures.	From the admission to the intensive care unit until the postoperative day 7 or until discharge from the ICU

Secondary Outcome Measures

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

Other Outcome Measures

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

Collaborators and Investigators

• Sponsor: Charles University, Czech Republic
• Collaborators: Military University Hospital, Prague
• Investigators: Study Chair: Pavel Záruba, MD., Department of Surgery 2nd Faculty of Medicine, Charles University

Publications and helpful links

General Publications

• Ball CG, Kirkpatrick AW, McBeth P. The secondary abdominal compartment syndrome: not just another post-traumatic complication. Can J Surg. 2008 Oct;51(5):399-405.
• Kirkpatrick AW, Roberts DJ, De Waele J, Jaeschke R, Malbrain ML, De Keulenaer B, Duchesne J, Bjorck M, Leppaniemi A, Ejike JC, Sugrue M, Cheatham M, Ivatury R, Ball CG, Reintam Blaser A, Regli A, Balogh ZJ, D'Amours S, Debergh D, Kaplan M, Kimball E, Olvera C; Pediatric Guidelines Sub-Committee for the World Society of the Abdominal Compartment Syndrome. Intra-abdominal hypertension and the abdominal compartment syndrome: updated consensus definitions and clinical practice guidelines from the World Society of the Abdominal Compartment Syndrome. Intensive Care Med. 2013 Jul;39(7):1190-206. doi: 10.1007/s00134-013-2906-z. Epub 2013 May 15.
• Reintam Blaser A, Regli A, De Keulenaer B, Kimball EJ, Starkopf L, Davis WA, Greiffenstein P, Starkopf J; Incidence, Risk Factors, and Outcomes of Intra-Abdominal (IROI) Study Investigators. Incidence, Risk Factors, and Outcomes of Intra-Abdominal Hypertension in Critically Ill Patients-A Prospective Multicenter Study (IROI Study). Crit Care Med. 2019 Apr;47(4):535-542. doi: 10.1097/CCM.0000000000003623.
• Smit M, Koopman B, Dieperink W, Hulscher JBF, Hofker HS, van Meurs M, Zijlstra JG. Intra-abdominal hypertension and abdominal compartment syndrome in patients admitted to the ICU. Ann Intensive Care. 2020 Oct 1;10(1):130. doi: 10.1186/s13613-020-00746-9.
• Mancilla Asencio C, Berger Fleiszig Z. Intra-Abdominal Hypertension: A Systemic Complication of Severe Acute Pancreatitis. Medicina (Kaunas). 2022 Jun 10;58(6):785. doi: 10.3390/medicina58060785.
• Hunter JD, Damani Z. Intra-abdominal hypertension and the abdominal compartment syndrome. Anaesthesia. 2004 Sep;59(9):899-907. doi: 10.1111/j.1365-2044.2004.03712.x.
• Leon M, Chavez L, Surani S. Abdominal compartment syndrome among surgical patients. World J Gastrointest Surg. 2021 Apr 27;13(4):330-339. doi: 10.4240/wjgs.v13.i4.330.
• Sugrue M, Jones F, Deane SA, Bishop G, Bauman A, Hillman K. Intra-abdominal hypertension is an independent cause of postoperative renal impairment. Arch Surg. 1999 Oct;134(10):1082-5. doi: 10.1001/archsurg.134.10.1082.
• Sugrue M, Buist MD, Hourihan F, Deane S, Bauman A, Hillman K. Prospective study of intra-abdominal hypertension and renal function after laparotomy. Br J Surg. 1995 Feb;82(2):235-8. doi: 10.1002/bjs.1800820234.
• Gray S, Christensen M, Craft J. The gastro-renal effects of intra-abdominal hypertension: Implications for critical care nurses. Intensive Crit Care Nurs. 2018 Oct;48:69-74. doi: 10.1016/j.iccn.2018.06.001. Epub 2018 Jun 21.
• De Waele JJ, De Laet I, Kirkpatrick AW, Hoste E. Intra-abdominal Hypertension and Abdominal Compartment Syndrome. Am J Kidney Dis. 2011 Jan;57(1):159-69. doi: 10.1053/j.ajkd.2010.08.034.

Study record dates

Study Major Dates

• Study Start (Estimated): January 1, 2025
• Primary Completion (Estimated): December 31, 2027
• Study Completion (Estimated): March 31, 2028

Study Registration Dates

• First Submitted: November 1, 2024
• First Submitted That Met QC Criteria: November 1, 2024
• First Posted (Actual): November 4, 2024

Study Record Updates

• Last Update Posted (Estimated): November 8, 2024
• Last Update Submitted That Met QC Criteria: November 7, 2024
• Last Verified: November 1, 2024

More Information

Terms related to this study

• Keywords: Compartment syndrome; Robotic surgery; Pancreatic surgery; Intra-abdominal hypertension
• Additional Relevant MeSH Terms: Neurologic Manifestations; Musculoskeletal Diseases; Vascular Diseases; Cardiovascular Diseases; Muscular Diseases; Postoperative Complications; Pathologic Processes; Pathological Conditions, Anatomical; Disease; Digestive System Diseases; Gastrointestinal Diseases; Stomach Diseases; Pancreatic Diseases; Paralysis; Digestive System Fistula; Fistula; Syndrome; Hypertension; Anastomotic Leak; Gastroparesis; Compartment Syndromes; Intra-Abdominal Hypertension; Pancreatic Fistula
• Other Study ID Numbers: 108/19-61/2024

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: All collected IPD that underlie results in a publication
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No