Intra-abdominal Hypertension and Abdominal Compartment Syndrome in Patients After Pancreatic Procedures.
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- This is an observational study: the protocol does not assign a study treatment.
- Who it may be relevant to
- Registry conditions: Intra Abdominal Pressure, Abdominal Compartment Syndrome, Pancreatic Surgery, Pancreatic Fistula After Pancreaticoduodenectomy. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Czechia
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
The HYPA Study: Intra-abdominal Hypertension and Abdominal Compartment Syndrome in Patients Undergoing Open and Robotic Pancreatic Procedures
Overview
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
Primary outcome measures
- 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]
Secondary outcome measures (1)
- Correlation between intra-abdominal hypertension and the development of postoperative complications. [Time frame: From the enrollment to the 90 days follow up period.]
Eligibility criteria
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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Cohort
Study locations
Czechia · 1 center
- Department of Surgery 2nd Faculty of Medicine, Charles University and Military University — Prague
Publications
- 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. PMID 33001288
- 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.0000000000 PMID 30608280
- 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. PMID 35744049
- 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. PMID 15310355
- 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. PMID 18841232
- 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. PMID 33968300
- 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. PMID 10522851
- 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. PMID 7749700
Identifiers
NCT: NCT06672601 · 108/19-61/2024