Clinical trial NCT06672601: Intra-abdominal Hypertension and Abdominal Compartment Syndrome in Patients After Pancreatic Procedures.
Official title: The HYPA Study: Intra-abdominal Hypertension and Abdominal Compartment Syndrome in Patients Undergoing Open and Robotic Pancreatic Procedures
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Intra Abdominal Pressure
Abdominal Compartment Syndrome
Pancreatic Surgery
Pancreatic Fistula After Pancreaticoduodenectomy
Delayed Gastric Emptying
Anastomotic Leaks
Overload Fluid
Keywords: Intra-abdominal hypertension
Compartment syndrome
Pancreatic surgery
Robotic surgery
Lead sponsor: Charles University, Czech Republic
Sponsor class: OTHER
Collaborators: name: Military University Hospital, Prague
First posted: 2024-11-04
Enrollment: 150
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: All patients undergoing open or robotic pancreatic procedures in our department.

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

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.

Primary outcomes:
measure: Prevalence of Intra-abdominal hypertension and abdominal compartment syndrome
timeFrame: From the admission to the intensive care unit until the postoperative day 7 or until discharge from the ICU
Secondary outcomes:
measure: Correlation between intra-abdominal hypertension and the development of postoperative complications.
timeFrame: From the enrollment to the 90 days follow up period.
Other outcomes:
measure: Incidence of Intra-abdominal hypertension in patients following robotic vs. open pancreatic procedure.
timeFrame: From the admission to the intensive care unit for 7 consecutive days or until discharge from the ICU.
Locations:
city: Prague
country: Czechia
facility: Department of Surgery 2nd Faculty of Medicine, Charles University and Military University Hospital Prague
state: Prague 6
Study officials:
affiliation: Department of Surgery 2nd Faculty of Medicine, Charles University
name: Pavel Záruba, MD.
role: STUDY_CHAIR
References:
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citation: 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.