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

NCT06672601 | Not Yet Recruiting

• 1 other identifier: 108/19-61/2024
• Study Type: observational
• Target: 150
• Locations: 1 country
• Sites: 1

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.

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

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

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

  From the enrollment to the 90 days follow up period.

Other Outcomes (1)

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

  From the admission to the intensive care unit for 7 consecutive days or until discharge from the ICU.

Study Arms (1)

Patients after pancreatic procedures

All patients following pancreatic procedure

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

• Patients ≥ 18-year-old
• Indication for elective pancreatic procedure
• Written informed consent

You may not qualify if:

• Patients \<18 years old.
• Contraindication for urinary catheter placement.
• Refusal to participate in the study.

Sponsors & Collaborators

• Charles University, Czech Republic: lead
• Military University Hospital, Prague: collaborator

Study Sites (1)

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

Prague, Prague 6, 169 02, Czechia

Location

Related Publications (11)

• 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 BACKGROUND

• 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.

  PMID: 30608280 BACKGROUND

• 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 BACKGROUND

• 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 BACKGROUND

• 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 BACKGROUND

• 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 BACKGROUND

• 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 BACKGROUND

• 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 BACKGROUND

• 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.

  PMID: 29937073 BACKGROUND

• 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.

  PMID: 21184922 BACKGROUND

• 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.

  PMID: 23673399 RESULT

MeSH Terms

Conditions

Intra-Abdominal Hypertension; Gastroparesis; Anastomotic Leak; Edema; Compartment Syndromes

Condition Hierarchy (Ancestors)

Muscular Diseases; Musculoskeletal Diseases; Vascular Diseases; Cardiovascular Diseases; Stomach Diseases; Gastrointestinal Diseases; Digestive System Diseases; Paralysis; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Postoperative Complications; Pathologic Processes

Study Officials

• Pavel Záruba, MD.

  Department of Surgery 2nd Faculty of Medicine, Charles University

  STUDY CHAIR

Central Study Contacts

Štěpán-Ota Schütz, MD.

CONTACT

00420 733224640; stepan.sch@gmail.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Surgical resident, Postgraduate student

Study Record Dates

• First Submitted: November 1, 2024
• First Posted: November 4, 2024
• Study Start: January 1, 2025
• Primary Completion (Estimated): December 31, 2027
• Study Completion (Estimated): March 31, 2028
• Last Updated: November 8, 2024

Record last verified: 2024-11

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL

Locations

CZ (1)