Renal- and Pulmonary Function in Relation to Abdominal Hypertension After Abdominal Reconstruction

NCT04143776 | Withdrawn DMC

• 1 other identifier: 1
• Study Type: observational
• Target: N/A
• Locations: 1 country
• Sites: 1

Brief Summary

An incisional hernia is technically challenging to operate and is the most frequent long-term complication after open surgery, resulting in impaired quality of life and reduced physical ability. Large hernias contain large amounts of abdominal volume, which similarly are missing from the abdominal cavity. Due to adaptations of the abdominal wall muscles and decreased space in the abdominal cavity, abdominal wall reconstruction lead to increased tension and thereby increased intraabdominal pressure. Reduced renal and lung function after surgery is one of the leading causes of prolonged hospitalization, increased costs and mortality. Elevated intraabdominal pressure is a known risk factor for kidney injury, but relationships between hernia surgery, increased intraabdominal pressure, renal and lung function are still unclear. Therefore, in patients undergoing surgery for incisional hernia, we will investigate the extent and consequences of elevated intraabdominal pressure, as well as its relation to renal injury and reduced lung function. We will also investigate the relationship between hernia dimensions and the development of increased intraabdominal pressure, as well as identifying patients at particular risk of developing elevated intraabdominal pressure. From April 2020 to October 2021, we will include 100 patients at Bispebjerg Hospital, Denmark, diagnosed with medium to giant incisional hernia, who will undergo scheduled surgery. Patients are followed from before to 30 days after surgery. They will be examined with CT scans before and after surgery. Blood tests, pulmonary function tests and measurement intraabdominal pressure will be performed before and until 3 days after surgery. Thirty days after surgery, lung function tests and blood tests are repeated at a final examination at the out-patient clinic. During follow-up, differences in hospital stay, complications, reoperations, and mortality will be investigated. Participation in the project is not associated with any side effects and risks. The study is expected great scientific gain, as the results can help identify particularly vulnerable patients in need of extended observation and treatment. The results obtained by the project are sought to be published in relevant scientific journals and conferences. The project is expected to extend over a 3-year period, which will include commissioning, data collection, analytical processing, dissemination of results and conduction of PhD thesis.

Conditions

Hernia, Ventral; Hernia Incisional; Acute Kidney Injury; Restrictive Lung Disease; Intraabdominal Hypertension

Keywords

hernia; abdominal reconstruction; intraabdominal pressure; acute kidney injury; restrictive lung disease

Outcome Measures

Primary Outcomes (3)

• Intraabdominal hypertension after abdominal reconstruction

  The primary aim is to investigate changes in the intraabdominal pressure after abdominal reconstruction.

  Before surgery, on postoperative day 1, 2 and 3.

• Pulmonary function in intraabdominal hypertension after abdominal reconstruction

  The primary aim is to investigate changes in the pulmonary areal after abdominal reconstruction through pre- and postoperative CT scans.

  Before surgery, on postoperative day 30.

• Surgical complications and intraabdominal hypertension after abdominal reconstruction

  The primary aims are to estimate length of stay in patients with and without intraabdominal hypertension.

  From surgery to postoperative day 30.

Secondary Outcomes (3)

• Intraabdominal hypertension after abdominal reconstruction

  Before surgery, on postoperative day 1, 2 and 3.

• Pulmonary function in intraabdominal hypertension after abdominal reconstruction

  Before surgery, during surgery, on postoperative day 1, 2, 3 and 30.

• Surgical complications and intraabdominal hypertension after abdominal reconstruction

  From surgery to postoperative day 30. Predicting factors are assessed preoperatively.

Interventions

Abdominal reconstruction PROCEDURE

No restrictions are set on surgical procedures or anaesthetic management.

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

Patients diagnosed with medium to giant incisional hernia undergoing planned open incisional hernia repair.

You may qualify if:

• Horizontal fascial defects of \>8 cm defined by preoperative CT scan
• Planned elective open incisional hernia repair

You may not qualify if:

• Pregnancy
• Previous bladder resection or reconstruction
• Chronic catheter use
• Inability to provide informed consent

Sponsors & Collaborators

• Bispebjerg Hospital: lead

Study Sites (1)

Digestive Disease Center, Bispebjerg Hospital

Copenhagen, DK-2400, Denmark

Location

Related Publications (25)

• Itatsu K, Yokoyama Y, Sugawara G, Kubota H, Tojima Y, Kurumiya Y, Kono H, Yamamoto H, Ando M, Nagino M. Incidence of and risk factors for incisional hernia after abdominal surgery. Br J Surg. 2014 Oct;101(11):1439-47. doi: 10.1002/bjs.9600. Epub 2014 Aug 14.

  PMID: 25123379 BACKGROUND

• Jensen KK, Munim K, Kjaer M, Jorgensen LN. Abdominal Wall Reconstruction for Incisional Hernia Optimizes Truncal Function and Quality of Life: A Prospective Controlled Study. Ann Surg. 2017 Jun;265(6):1235-1240. doi: 10.1097/SLA.0000000000001827.

  PMID: 27280505 BACKGROUND

• Kokotovic D, Bisgaard T, Helgstrand F. Long-term Recurrence and Complications Associated With Elective Incisional Hernia Repair. JAMA. 2016 Oct 18;316(15):1575-1582. doi: 10.1001/jama.2016.15217.

  PMID: 27750295 BACKGROUND

• Parker SG, Halligan S, Blackburn S, Plumb AAO, Archer L, Mallett S, Windsor ACJ. What Exactly is Meant by "Loss of Domain" for Ventral Hernia? Systematic Review of Definitions. World J Surg. 2019 Feb;43(2):396-404. doi: 10.1007/s00268-018-4783-7.

  PMID: 30187090 BACKGROUND

• Petro CC, Raigani S, Fayezizadeh M, Rowbottom JR, Klick JC, Prabhu AS, Novitsky YW, Rosen MJ. Permissible Intraabdominal Hypertension following Complex Abdominal Wall Reconstruction. Plast Reconstr Surg. 2015 Oct;136(4):868-881. doi: 10.1097/PRS.0000000000001621.

  PMID: 26090761 BACKGROUND

• Malbrain ML, De Laet IE, De Waele JJ, Kirkpatrick AW. Intra-abdominal hypertension: definitions, monitoring, interpretation and management. Best Pract Res Clin Anaesthesiol. 2013 Jun;27(2):249-70. doi: 10.1016/j.bpa.2013.06.009.

  PMID: 24012236 BACKGROUND

• Cheatham ML. Abdominal compartment syndrome: pathophysiology and definitions. Scand J Trauma Resusc Emerg Med. 2009 Mar 2;17:10. doi: 10.1186/1757-7241-17-10.

  PMID: 19254364 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 BACKGROUND

• Demarchi AC, de Almeida CT, Ponce D, e Castro MC, Danaga AR, Yamaguti FA, Vital D, Gut AL, Ferreira AL, Freschi L, Oliveira J, Teixeira UA, Christovan JC, Grejo JR, Martin LC. Intra-abdominal pressure as a predictor of acute kidney injury in postoperative abdominal surgery. Ren Fail. 2014 May;36(4):557-61. doi: 10.3109/0886022X.2013.876353. Epub 2014 Jan 23.

  PMID: 24456177 BACKGROUND

• O'Connor ME, Kirwan CJ, Pearse RM, Prowle JR. Incidence and associations of acute kidney injury after major abdominal surgery. Intensive Care Med. 2016 Apr;42(4):521-530. doi: 10.1007/s00134-015-4157-7. Epub 2015 Nov 24.

  PMID: 26602784 BACKGROUND

• Chertow GM, Burdick E, Honour M, Bonventre JV, Bates DW. Acute kidney injury, mortality, length of stay, and costs in hospitalized patients. J Am Soc Nephrol. 2005 Nov;16(11):3365-70. doi: 10.1681/ASN.2004090740. Epub 2005 Sep 21.

  PMID: 16177006 BACKGROUND

• Biteker M, Dayan A, Tekkesin AI, Can MM, Tayci I, Ilhan E, Sahin G. Incidence, risk factors, and outcomes of perioperative acute kidney injury in noncardiac and nonvascular surgery. Am J Surg. 2014 Jan;207(1):53-9. doi: 10.1016/j.amjsurg.2013.04.006. Epub 2013 Sep 17.

  PMID: 24050540 BACKGROUND

• Kheterpal S, Tremper KK, Heung M, Rosenberg AL, Englesbe M, Shanks AM, Campbell DA Jr. Development and validation of an acute kidney injury risk index for patients undergoing general surgery: results from a national data set. Anesthesiology. 2009 Mar;110(3):505-15. doi: 10.1097/ALN.0b013e3181979440.

  PMID: 19212261 BACKGROUND

• da Silva Almeida JR, Machado FS, Schettino GP, Park M, Azevedo LC. Cardiopulmonary effects of matching positive end-expiratory pressure to abdominal pressure in concomitant abdominal hypertension and acute lung injury. J Trauma. 2010 Aug;69(2):375-83. doi: 10.1097/TA.0b013e3181e12b3a.

  PMID: 20699747 BACKGROUND

• Soltanizadeh S, Helgstrand F, Jorgensen LN. Botulinum Toxin A as an Adjunct to Abdominal Wall Reconstruction for Incisional Hernia. Plast Reconstr Surg Glob Open. 2017 Jun 21;5(6):e1358. doi: 10.1097/GOX.0000000000001358. eCollection 2017 Jun.

  PMID: 28740773 BACKGROUND

• Nguyen DH, Nguyen MT, Askenasy EP, Kao LS, Liang MK. Primary fascial closure with laparoscopic ventral hernia repair: systematic review. World J Surg. 2014 Dec;38(12):3097-104. doi: 10.1007/s00268-014-2722-9.

  PMID: 25145817 BACKGROUND

• Quan H, Li B, Couris CM, Fushimi K, Graham P, Hider P, Januel JM, Sundararajan V. Updating and validating the Charlson comorbidity index and score for risk adjustment in hospital discharge abstracts using data from 6 countries. Am J Epidemiol. 2011 Mar 15;173(6):676-82. doi: 10.1093/aje/kwq433. Epub 2011 Feb 17.

  PMID: 21330339 BACKGROUND

• Kimball EJ, Mone MC, Wolfe TR, Baraghoshi GK, Alder SC. Reproducibility of bladder pressure measurements in critically ill patients. Intensive Care Med. 2007 Jul;33(7):1195-1198. doi: 10.1007/s00134-007-0641-z. Epub 2007 Apr 28.

  PMID: 17468849 BACKGROUND

• Cheatham ML, De Waele JJ, De Laet I, De Keulenaer B, Widder S, Kirkpatrick AW, Cresswell AB, Malbrain M, Bodnar Z, Mejia-Mantilla JH, Reis R, Parr M, Schulze R, Puig S; World Society of the Abdominal Compartment Syndrome (WSACS) Clinical Trials Working Group. The impact of body position on intra-abdominal pressure measurement: a multicenter analysis. Crit Care Med. 2009 Jul;37(7):2187-90. doi: 10.1097/CCM.0b013e3181a021fa.

  PMID: 19487946 BACKGROUND

• Dempsey TM, Scanlon PD. Pulmonary Function Tests for the Generalist: A Brief Review. Mayo Clin Proc. 2018 Jun;93(6):763-771. doi: 10.1016/j.mayocp.2018.04.009.

  PMID: 29866281 BACKGROUND

• Kellum JA, Lameire N; KDIGO AKI Guideline Work Group. Diagnosis, evaluation, and management of acute kidney injury: a KDIGO summary (Part 1). Crit Care. 2013 Feb 4;17(1):204. doi: 10.1186/cc11454.

  PMID: 23394211 BACKGROUND

• Clavien PA, Barkun J, de Oliveira ML, Vauthey JN, Dindo D, Schulick RD, de Santibanes E, Pekolj J, Slankamenac K, Bassi C, Graf R, Vonlanthen R, Padbury R, Cameron JL, Makuuchi M. The Clavien-Dindo classification of surgical complications: five-year experience. Ann Surg. 2009 Aug;250(2):187-96. doi: 10.1097/SLA.0b013e3181b13ca2.

  PMID: 19638912 BACKGROUND

• Mazzocchi M, Dessy LA, Sorvillo V, Di Ronza S, Scuderi N. A study of intraabdominal pressure modification in "component separation" technique for repair of incisional hernia. Ann Ital Chir. 2010 Nov-Dec;81(6):433-7.

  PMID: 21456479 BACKGROUND

• Blatnik JA, Krpata DM, Pesa NL, Will P, Harth KC, Novitsky YW, Rowbottom JR, Rosen MJ. Predicting severe postoperative respiratory complications following abdominal wall reconstruction. Plast Reconstr Surg. 2012 Oct;130(4):836-841. doi: 10.1097/PRS.0b013e318262f160.

  PMID: 22691844 BACKGROUND

• Chung CU, Nelson JA, Fischer JP, Wink JD, Serletti JM, Kovach SJ. Acute kidney injury after open ventral hernia repair: an analysis of the 2005-2012 ACS-NSQIP datasets. Hernia. 2016 Feb;20(1):131-8. doi: 10.1007/s10029-015-1395-0. Epub 2015 Jun 23.

  PMID: 26099501 BACKGROUND

MeSH Terms

Conditions

Hernia, Ventral; Incisional Hernia; Acute Kidney Injury; Intra-Abdominal Hypertension; Hernia

Condition Hierarchy (Ancestors)

Hernia, Abdominal; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms; Postoperative Complications; Pathologic Processes; Renal Insufficiency; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Compartment Syndromes; Muscular Diseases; Musculoskeletal Diseases; Vascular Diseases; Cardiovascular Diseases

Study Officials

• Sinor Soltanizadeh, MD

  Digestive Disease Center, Bispebjerg Hospital, University of Copenhagen

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Medical Doctor, Ph.D.-student

Study Record Dates

• First Submitted: October 26, 2019
• First Posted: October 29, 2019
• Study Start: June 1, 2020
• Primary Completion: December 30, 2020
• Study Completion: December 30, 2020
• Last Updated: February 27, 2023

Record last verified: 2023-02

Locations

DK (1)