PREDICtors for health-related quality of life after elective sigmoidectomy for DIVerticular disease: the PREDIC-DIV study protocol of a prospective multicentric transnational observational study

Maximilian Sohn, Ayman Agha, Igors Iesalnieks, Susanne Bremer, Stefanie Trum, Francesca Di Cerbo, Andreas Nerlich, Natalie Lotz, Eckhard Klieser, Alfred Hochrein, Philipp Schredl, Dariya Kalcheva, Klaus Emmanuel, Jaroslav Presl, Maximilian Sohn, Ayman Agha, Igors Iesalnieks, Susanne Bremer, Stefanie Trum, Francesca Di Cerbo, Andreas Nerlich, Natalie Lotz, Eckhard Klieser, Alfred Hochrein, Philipp Schredl, Dariya Kalcheva, Klaus Emmanuel, Jaroslav Presl

Abstract

Introduction: Diverticulitis is among the most common abdominal disorders. The best treatment strategy for this complicated disease as well as for recurrent stages is still under debate. Moreover, little knowledge exists regarding the effect of different therapeutic strategies on the health-related quality of life (HrQoL). Therefore, the PREDIC-DIV (PREDICtors for health-related quality of life after elective sigmoidectomy for DIVerticular disease) study aims to assess predictors of a change in HrQoL in patients after elective sigmoidectomy for diverticular disease.

Methods and analysis: A prospective multicentre transnational observational study was started in November 2017. Patients undergoing elective sigmoid resection for diverticular disease were included. Primary outcome includes HrQoL 6 months postoperatively, staged by the Gastrointestinal Quality of Life Index (GIQLI). Secondary outcomes include HrQoL 6 months after sigmoidectomy, assessed using the Short Form 36 Questionnaire and a custom-made Visual Analogue Scale-based inventory; HrQoL after 12 and 24 months; postoperative morbidity; mortality; influence of surgical technique (conventional laparoscopic multiport operation vs robotic approach); histological grading of inflammation and morphological characteristics of the bowel wall in the resected specimen; postoperative functional changes (faecal incontinence, faecal urge, completeness of emptying, urinary incontinence, sexual function); disease-specific healthcare costs; and changes in economic productivity, measured by the iMTA Productivity Cost Questionnaire. The total follow-up will be 2 years.

Ethics and dissemination: The protocol was approved by the medical ethical committee of the Bavarian Medical Council (report identification number: 2017-177). The study was conducted in accordance with the Declaration of Helsinki. The findings of this study will be submitted to a peer-reviewed journal (BMJ Open, Annals of Surgery, British Journal of Surgery, Diseases of the Colon and the Rectum). Abstracts will be submitted to relevant national and international conferences.

Trial registration number: The study is registered with the ClinicalTrials.gov register as NCT03527706; Pre-results.

Keywords: adult surgery; clinical trials; colorectal surgery.

Conflict of interest statement

Competing interests: None declared.

© Author(s) (or their employer(s)) 2020. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ.

Figures

Figure 1
Figure 1
Study flow and inclusion and exclusion criteria.

References

    1. Bharucha AE, Parthasarathy G, Ditah I, et al. . Temporal trends in the incidence and natural history of diverticulitis: a population-based study. Am J Gastroenterol 2015;110:1589–96.10.1038/ajg.2015.302
    1. Simianu VV, Bastawrous AL, Billingham RP, et al. . Addressing the appropriateness of elective colon resection for diverticulitis: a report from the SCOAP certain collaborative. Ann Surg 2014;260:533–8. discussion 538-539.
    1. Kruis W, Germer C-T, Leifeld L. German Society for gastroenterology, digestive and metabolic diseases and the German Society for general and visceral surgery. diverticular disease: guidelines of the German Society for gastroenterology, digestive and metabolic diseases and the German Society for general and visceral surgery. Digestion 2014;90:190–207.
    1. Feingold D, Steele SR, Lee S, et al. . Practice parameters for the treatment of sigmoid diverticulitis. Dis Colon Rectum 2014;57:284–94.10.1097/DCR.0000000000000075
    1. Leifeld L, Germer CT, Böhm S, et al. . S2k guidelines diverticular disease/diverticulitis]. Z Für Gastroenterol 2014;52:663–710.
    1. Andersen JC, Bundgaard L, Elbrønd H, et al. . Danish national guidelines for treatment of diverticular disease. Dan Med J 2012;59:C4453.
    1. Andeweg CS, Mulder IM, Felt-Bersma RJF, et al. . Guidelines of diagnostics and treatment of acute left-sided colonic diverticulitis. Dig Surg 2013;30:278–92.10.1159/000354035
    1. Eypasch E, Williams JI, Wood-Dauphinee S, et al. . Gastrointestinal quality of life index: development, validation and application of a new instrument. Br J Surg 1995;82:216–22.10.1002/bjs.1800820229
    1. Stam MAW, Arensman L, Stellato RK, et al. . The relation between quality of life and histopathology in diverticulitis; can we predict specimen-related outcome? Int J Colorectal Dis 2015;30:665–71.10.1007/s00384-015-2176-z
    1. van de Wall BJM, Draaisma WA, Consten ECJ, et al. . Direct trial. diverticulitis recurrences or continuing symptoms: operative versus conservative treatment. A multicenter randomised clinical trial. BMC Surg 2010;10:2510.1186/1471-2482-10-25
    1. Forgione A, Leroy J, Cahill RA, et al. . Prospective evaluation of functional outcome after laparoscopic sigmoid colectomy. Ann Surg 2009;249:218–24.10.1097/SLA.0b013e318195c5fc
    1. Unlü C, Beenen LFM, Fauquenot JMB, et al. . Inter-Observer reliability of computed tomographic classifications of diverticulitis. Colorectal Dis 2014;16:O212–9.10.1111/codi.12533
    1. Klarenbeek BR, de Korte N, van der Peet DL, et al. . Review of current classifications for diverticular disease and a translation into clinical practice. Int J Colorectal Dis 2012;27:207–14.10.1007/s00384-011-1314-5
    1. Klarenbeek BR, Veenhof AA, Bergamaschi R, et al. . Laparoscopic sigmoid resection for diverticulitis decreases major morbidity rates: a randomized control trial: short-term results of the sigma trial. Ann Surg 2009;249:39–44.10.1097/SLA.0b013e31818e416a
    1. Collins D, Winter DC. Elective resection for diverticular disease: an evidence-based review. World J Surg 2008;32:2429–33.10.1007/s00268-008-9705-7
    1. Ambrosetti P, Gervaz P, Fossung-Wiblishauser A. Sigmoid diverticulitis in 2011: many questions; few answers. Colorectal Disease 2012;14:e439–46.10.1111/j.1463-1318.2012.03026.x
    1. Egger B, Peter MK, Candinas D. Persistent symptoms after elective sigmoid resection for diverticulitis. Dis Colon Rectum 2008;51:1044–8.10.1007/s10350-008-9234-3
    1. Levack MM, Savitt LR, Berger DL, et al. . Sigmoidectomy syndrome? Patientsʼ perspectives on the functional outcomes following surgery for diverticulitis. Dis Colon Rectum 2012;55:10–17.10.1097/DCR.0b013e31823907a9
    1. Bullinger M. German translation and psychometric testing of the SF-36 health survey: preliminary results from the IQOLA project. International quality of life assessment. Soc Sci Med 1995;41:1359–66.10.1016/0277-9536(95)00115-n
    1. Dindo D, Demartines N, Clavien P-A. Classification of surgical complications: a new proposal with evaluation in a cohort of 6336 patients and results of a survey. Ann Surg 2004;240:205–13.10.1097/
    1. Jorge MJN, Wexner SD. Etiology and management of fecal incontinence. Dis Colon Rectum 1993;36:77–97.10.1007/BF02050307
    1. Temple LK, Bacik J, Savatta SG, et al. . The development of a validated instrument to evaluate bowel function after sphincter-preserving surgery for rectal cancer. Dis Colon Rectum 2005;48:1353–65.10.1007/s10350-004-0942-z
    1. Emmertsen KJ, Laurberg S. Low anterior resection syndrome score: development and validation of a symptom-based scoring system for bowel dysfunction after low anterior resection for rectal cancer. Ann Surg 2012;255:922–8.10.1097/SLA.0b013e31824f1c21
    1. Shumaker SA, Wyman JF, Uebersax JS, et al. . Health-Related quality of life measures for women with urinary incontinence: the incontinence impact questionnaire and the urogenital distress inventory. Quality of Life Research 1994;3:291–306.10.1007/BF00451721
    1. Utomo E, Korfage IJ, Wildhagen MF, et al. . Validation of the urogenital distress inventory (UDI-6) and incontinence impact questionnaire (IIQ-7) in a Dutch population. Neurourol Urodyn 2015;34:24–31.10.1002/nau.22496
    1. Cappelleri JC, Rosen RC, Smith MD, et al. . Diagnostic evaluation of the erectile function domain of the International index of erectile function. Urology 1999;54:346–51.10.1016/S0090-4295(99)00099-0
    1. Rosen R, Brown C, Heiman J, et al. . The female sexual function index (FSFI): a multidimensional self-report instrument for the assessment of female sexual function. J Sex Marital Ther 2000;26:191–208.10.1080/009262300278597
    1. Bouwmans C, Krol M, Severens H, et al. . The iMTA Productivity Cost questionnaire: a standardized instrument for measuring and Valuing health-related productivity losses. Value Health 2015;18:753–8.10.1016/j.jval.2015.05.009

Source: PubMed

Sponsorit ja yhteistyökumppanit

Sairaudet

Huumeiden interventiot

3
Tilaa