RETention of urine After INguinal hernia Elective Repair (RETAINER study I and II)

Irish Surgical Research Collaborative, Stefanie M Croghan, Christina A Fleming, Helen M Mohan, Deena Harji, Jarlath C Bolger, Jessie A Elliott, Michael Boland, Peter E Lonergan, Patrick Dillon, David M Quinlan, Des C Winter, Irish Surgical Research Collaborative, Stefanie M Croghan, Christina A Fleming, Helen M Mohan, Deena Harji, Jarlath C Bolger, Jessie A Elliott, Michael Boland, Peter E Lonergan, Patrick Dillon, David M Quinlan, Des C Winter

Abstract

Purpose: Post-operative urinary retention (POUR) is a well-recognised complication of inguinal hernia repair (IHR). The magnitude of the problem is unclear, and contradictory evidence surrounds postulated risk factors. POUR risks patient distress, catheter-complications and a financial and logistical burden to services. Separately, in the field of IHR, there has been a lack of research into patients' perceptions of surgical 'success'. Our aim is to perform a two-phase, multi-centre prospective study to:Assess the rate, risk factors and impact related to POUR post IH repair.Develop and validate a patient reported outcome measure (PROM) for inguinal hernia repair.

Methods: RETAINER I: We propose a 24-week prospective study with voluntary international participation in 4 week blocks. All patients undergoing elective IH repair (minimally-invasive/open) will be eligible. Standardised data collection will include patient and perioperative factors. Primary outcome will be development of POUR, defined as the need for insertion of a urinary catheter as determined by the treating clinician. Secondary outcomes will be identification of factors predisposing to POUR and the impact of POUR.RETAINER II: A patient reported outcome measure will be developed using representative patient focus groups for item generation, from which an initial questionnaire will be developed and piloted. Validity, reliability, sensitivity and reproducibility will be assessed using the QQ-10 and standard psychometric methodology.

Conclusions: Using an international multicentre collaborative approach will produce the necessary volume of patients, whilst capturing inter-centre variability, to accurately reflect POUR rates and allow analysis of risk factors. This patient pool will provide an excellent opportunity to develop a PROM using appropriate qualitative methodology.

Highlights retainer i & ii protocols: RETAINER (RETention of urine After INguinal hernia Elective Repair) I is a prospective, multicentre, international observational study.RETAINER I aims to explore the incidence of and risk factors for urinary retention following elective inguinal hernia repair.Urinary retention following inguinal hernia repair has a marked impact on patients and creates a significant financial and logistical burden for hospital services.RETAINER II is a prospective, qualitative study, recruiting patients to guide the creation of a patient-reported outcome measure (PROM) for elective inguinal hernia repair.

Keywords: Inguinal hernia; POUR; Protocol; Urinary retention; postoperative.

Conflict of interest statement

The authors have no competing interests to declare.

Copyright: © 2021 The Author(s).

References

    1. Blair AB, Dwarakanath A, Mehta A, Liang H, Hui X, Wyman C, Ouanes JPP, Nguyen HT. Postoperative urinary retention after inguinal hernia repair: a single institution experience. Hernia. 2017; 21(6): 895–900. DOI: 10.1007/s10029-017-1661-4
    1. Hudak KE, Frelich MJ, Rettenmaier CR, Xiang Q, Wallace JR, Kastenmeier AS, Gould JC, Goldblatt MI. Surgery duration predicts urinary retention after inguinal herniorrhaphy: a single institution review. Surg Endosc. 2015; 29(11): 3246–3250. DOI: 10.1007/s00464-015-4068-2
    1. Patel JA, Kaufman AS, Howard RS, Rodriguez CJ, Jessie EM. Risk factors for urinary retention after laparoscopic inguinal hernia repairs. Surg Endosc. 2015; 29(11): 3140–3145. DOI: 10.1007/s00464-014-4039-z
    1. Shaw MK, Pahari H. The role of peri-operative use of alpha-blocker in preventing lower urinary tract symptoms in high risk patients of urinary retention undergoing inguinal hernia repair in males above 50 years. J Indian Med Assoc. 2014; 112(1): 13–14, 16.
    1. El-Dhuwaib Y, Corless D, Emmett C, Deakin M, Slavin J. Laparoscopic versus open repair of inguinal hernia: a longitudinal cohort study. Surg Endosc. 2013; 27(3): 936–945. DOI: 10.1007/s00464-012-2538-3
    1. Rafiq MK, Sultan B, Malik MA, Khan K, Abbasi MA. Efficacy Of Local Anaesthesia In Repair Of Inguinal Hernia. J Ayub Med Coll Abbottabad. 2016; 28(4): 755–757.
    1. Koch CA, Grinberg GG, Farley DR. Incidence and risk factors for urinary retention after endoscopic hernia repair. Am J Surg. 2006; 191(3): 381–385. DOI: 10.1016/j.amjsurg.2005.10.042
    1. Winslow ER, Quasebarth M, Brunt LM. Perioperative outcomes and complications of open vs laparoscopic extraperitoneal inguinal hernia repair in a mature surgical practice. Surg Endosc. 2004; 18(2): 221–227. DOI: 10.1007/s00464-003-8934-y
    1. Vanclooster P, Smet B, de Gheldere C, Segers K. Laparoscopic inguinal hernia repair: review of 6 years experience. Acta Chir Belg. 2001; 101(3): 135–138. DOI: 10.1080/00015458.2001.12098603
    1. Lau H, Lee F. An audit of the early outcomes of ambulatory inguinal hernia repair at a surgical day-care centre. Hong Kong Med J. 2000; 6(2): 218–220.
    1. Grau-Talens EJ, Ibanez CD, Motos-Mico J, Garcia-Olives F, Arribas-Jurado M, Jordan-Chaves C, Aparicio-Gallego JM, Salgado JF. Rives Technique for the Primary Larger Inguinal Hernia Repair: A Prospective Study of 1000 Repairs. World J Surg. 2017; 41(10): 2480–2487. DOI: 10.1007/s00268-017-4038-z
    1. Prakash D, Heskin L, Doherty S, Galvin R. Local anaesthesia versus spinal anaesthesia in inguinal hernia repair: A systematic review and meta-analysis. Surgeon. 2017; 15(1): 47–57. DOI: 10.1016/j.surge.2016.01.001
    1. Baldini G, Bagry H, Aprikian A, Carli F. Postoperative urinary retention: anesthetic and perioperative considerations. Anesthesiology. 2009; 110(5): 1139–1157. DOI: 10.1097/ALN.0b013e31819f7aea
    1. Saint S, Lipsky BA, Goold SD. Indwelling urinary catheters: a one-point restraint? Ann Intern Med. 2002; 137(2): 125–127. DOI: 10.7326/0003-4819-137-2-200207160-00012
    1. Saint S, Trautner BW, Fowler KE, Colozzi J, Ratz D, Lescinskas E, Hollingsworth JM, Krein SL. A Multicenter Study of Patient-Reported Infectious and Noninfectious Complications Associated With Indwelling Urethral Catheters. JAMA Intern Med. 2018. DOI: 10.1001/jamainternmed.2018.2417
    1. Umscheid CA, Mitchell MD, Doshi JA, Agarwal R, Williams K, Brennan PJ. Estimating the proportion of healthcare-associated infections that are reasonably preventable and the related mortality and costs. Infect Control Hosp Epidemiol. 2011; 32(2): 101–114. DOI: 10.1086/657912
    1. Gardner A, Mitchell B, Beckingham W, Fasugba O. A point prevalence cross-sectional study of healthcare-associated urinary tract infections in six Australian hospitals. BMJ Open. 2014; 4(7): e005099. DOI: 10.1136/bmjopen-2014-005099
    1. Saint S. Clinical and economic consequences of nosocomial catheter-related bacteriuria. Am J Infect Control. 2000; 28(1): 68–75. DOI: 10.1016/S0196-6553(00)90015-4
    1. Control. ECfDPa. Point prevalence survey of healthcare-associated infections and antimicrobial use in European acute care hospitals 2011–2012. Stockholm. 2013.
    1. Scotland HP. Scottish national point prevalence survey of healthcare associated infection and antimicrobial prescribing 2011. Scotland: Health Protection Scotlan. 2012.
    1. Melzer M, Welch C. Outcomes in UK patients with hospital-acquired bacteraemia and the risk of catheter-associated urinary tract infections. Postgrad Med J. 2013; 89(1052): 329–334. DOI: 10.1136/postgradmedj-2012-131393
    1. Hollingsworth JM, Rogers MA, Krein SL, Hickner A, Kuhn L, Cheng A, Chang R, Saint S. Determining the noninfectious complications of indwelling urethral catheters: a systematic review and meta-analysis. Ann Intern Med. 2013; 159(6): 401–410. DOI: 10.7326/0003-4819-159-6-201309170-00006
    1. Davis NF, Mooney RO, O’Brien MF, Walsh MT. Attitudes among junior doctors towards improving the transurethral catheterisation process. Ir J Med Sci. 2015; 184(2): 365–367. DOI: 10.1007/s11845-014-1120-5
    1. Davis NF, Quinlan MR, Bhatt NR, Browne C, MacCraith E, Manecksha R, Walsh MT, Thornhill JA, Mulvin D. Incidence, Cost, Complications and Clinical Outcomes of Iatrogenic Urethral Catheterization Injuries: A Prospective Multi-Institutional Study. J Urol. 2016; 196(5): 1473–1477. DOI: 10.1016/j.juro.2016.05.114
    1. Trout S, Dattolo J, Hansbrough JF. Catheterization: how far should you go? RN. 1993; 56(8): 52–54.
    1. Lau H, Brooks DC. Predictive factors for unanticipated admissions after ambulatory laparoscopic cholecystectomy. Arch Surg. 2001; 136(10): 1150–1153. DOI: 10.1001/archsurg.136.10.1150
    1. Awan FN, Zulkifli MS, McCormack O, Manzoor T, Ravi N, Mehigan B, Reynolds JV. Factors involved in unplanned admissions from general surgical day-care in a modern protected facility. Ir Med J. 2013; 106(5): 153–154.
    1. Castoro C, Bertinato L, Baccaglini U, Drace CA, McKee M, Collaboration I. Day Surgery: Making it Happen. World Health Organisation, European Observatory on Health Systems & Policies. 2007.
    1. Hollenbeak CS, Schilling AL. The attributable cost of catheter-associated urinary tract infections in the United States: A systematic review. Am J Infect Control. 2018; 46(7): 751–757. DOI: 10.1016/j.ajic.2018.01.015
    1. Bhatt NR, Davis NF, Addie D, Flynn R, McDermott TED, Manecksha RP, Thornhill JA. Evaluating the cost of iatrogenic urethral catheterisation injuries. Ir J Med Sci. 2017; 186(4): 1051–1055. DOI: 10.1007/s11845-016-1451-5
    1. von Elm E, Altman DG, Egger M, Pocock SJ, Gotzsche PC, Vandenbroucke JP, Initiative S. The Strengthening the Reporting of Observational Studies in Epidemiology (STROBE) statement: guidelines for reporting observational studies. Lancet. 2007; 370(9596): 1453–1457. DOI: 10.1016/S0140-6736(07)61602-X
    1. Harji DP, Vallance A, Selgimann J, Bach S, Mohamed F, Brown J, Fearnhead N. A systematic analysis highlighting deficiencies in reported outcomes for patients with stage IV colorectal cancer undergoing palliative resection of the primary tumour. European journal of surgical oncology: the journal of the European Society of Surgical Oncology and the British Association of Surgical Oncology. 2018; 44(10): 1469–1478. DOI: 10.1016/j.ejso.2018.06.012
    1. Magnusson J, Gustafsson UO, Nygren J, Thorell A. Sustainability of the relationship between preoperative symptoms and postoperative improvement in quality of life after inguinal hernia repair. Hernia. 2019; 23(3): 583–591. DOI: 10.1007/s10029-018-01875-8
    1. Health USDo, Human Services FDACfDE, Research, Health USDo, Human Services FDACfBE, Research, Health USDo, Human Services FDACfD, Radiological H. Guidance for industry: patient-reported outcome measures: use in medical product development to support labeling claims: draft guidance. Health Qual Life Outcomes. 2006; 4: 79. DOI: 10.1186/1477-7525-4-79
    1. Brod M, Tesler LE, Christensen TL. Qualitative research and content validity: developing best practices based on science and experience. Qual Life Res. 2009; 18(9): 1263–1278. DOI: 10.1007/s11136-009-9540-9
    1. Patrick DL, Burke LB, Gwaltney CJ, Leidy NK, Martin ML, Molsen E, Ring L. Content validity--establishing and reporting the evidence in newly developed patient-reported outcomes (PRO) instruments for medical product evaluation: ISPOR PRO Good Research Practices Task Force report: part 2--assessing respondent understanding. Value Health. 2011; 14(8): 978–988. DOI: 10.1016/j.jval.2011.06.013
    1. Rothman M, Burke L, Erickson P, Leidy NK, Patrick DL, Petrie CD. Use of existing patient-reported outcome (PRO) instruments and their modification: the ISPOR Good Research Practices for Evaluating and Documenting Content Validity for the Use of Existing Instruments and Their Modification PRO Task Force Report. Value Health. 2009; 12(8): 1075–1083. DOI: 10.1111/j.1524-4733.2009.00603.x
    1. Aaronson N, Alonso J, Burnam A, Lohr KN, Patrick DL, Perrin E, Stein RE. Assessing health status and quality-of-life instruments: attributes and review criteria. Qual Life Res. 2002; 11(3): 193–205.
    1. Moores KL, Jones GL, Radley SC. Development of an instrument to measure face validity, feasibility and utility of patient questionnaire use during health care: the QQ-10. Int J Qual Health Care. 2012. 24(5): 517–524. DOI: 10.1093/intqhc/mzs051
    1. Wu Ma, Tam HPa, Jen T-Ha. Educational measurement for applied researchers: theory into practice.
    1. Heniford BT, Walters AL, Lincourt AE, Novitsky YW, Hope WW, Kercher KW. Comparison of generic versus specific quality-of-life scales for mesh hernia repairs. J Am Coll Surg. 2008; 206(4): 638–644. DOI: 10.1016/j.jamcollsurg.2007.11.025
    1. Muysoms FE, Vanlander A, Ceulemans R, Kyle-Leinhase I, Michiels M, Jacobs I, Pletinckx P, Berrevoet F. A prospective, multicenter, observational study on quality of life after laparoscopic inguinal hernia repair with ProGrip laparoscopic, self-fixating mesh according to the European Registry for Abdominal Wall Hernias Quality of Life Instrument. Surgery. 2016; 160(5): 1344–1357. DOI: 10.1016/j.surg.2016.04.026
    1. Nunnally JC. Psychometric theory. McGraw-Hill series in psychology, 2nd edn. New York: McGraw-Hill. 1978.
    1. Nunnally JC, Bernstein IH. Psychometric theory. McGraw-Hill series in psychology, 3rd edn. New York: McGraw-Hill. 1994.
    1. Mc Coll E, Jacoby A, Thomas L, Soutter J, Bamford C, Steen N, Thomas R, Harvey E, Garratt A, Bond J. Design and use of questionnaires: a review of best practice applicable to surveys of health service staff and patients. vol 5, No. 31. United Kingdom: NHS Health Technology Assessment. 2001. DOI: 10.3310/hta5310
    1. Barofsky I, Meadows K, McColl E. Cognitive aspects of survey methodology and quality of life assessment: summary of meeting. Qual Life Res. 2003; 12(3): 281–282
    1. Tourangeau R, Rips LJ, Rasinski KA. The psychology of survey response. Cambridge: Cambridge University Press. 2000. DOI: 10.1017/CBO9780511819322
    1. Irish Surgical Research C. PERioperative Fluid Management in Elective ColecTomy (PERFECT)-a national prospective cohort study. Ir J Med Sci. 2019; 188(4): 1363–1371. DOI: 10.1007/s11845-019-02003-w

Source: PubMed

Patrocinadores e Colaboradores

Condições médicas

Intervenções de drogas

3
Se inscrever