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Published in: Trials 1/2020

Open Access 01-12-2020 | Rectal Cancer | Study protocol

Pelvic floor rehabilitation to improve functional outcome and quality of life after surgery for rectal cancer: study protocol for a randomized controlled trial (FORCE trial)

Authors: A.J. Kalkdijk-Dijkstra, J.A.G. van der Heijden, H.L. van Westreenen, P.M.A. Broens, M. Trzpis, J.P.E.N. Pierie, B.R. Klarenbeek, FORCE Trial Group

Published in: Trials | Issue 1/2020

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Abstract

Background

After low anterior resection (LAR), up to 90% of patients develop anorectal dysfunction. Especially fecal incontinence has a major impact on the physical, psychological, social, and emotional functioning of the patient but also on the Dutch National Healthcare budget with more than €2000 spent per patient per year. No standardized treatment is available to help these patients. Common treatment nowadays is focused on symptom relief, consisting of lifestyle advices and pharmacotherapy with bulking agents or antidiarrheal medication. Another possibility is pelvic floor rehabilitation (PFR), which is one of the most important treatments for fecal incontinence in general, with success rates of 50–80%. No strong evidence is available for the use of PFR after LAR. This study aims to prove a beneficial effect of PFR on fecal incontinence, quality of life, and costs in rectal cancer patients after sphincter-saving surgery compared to standard treatment.

Methods

The FORCE trial is a multicenter, two-armed, randomized clinical trial. All patients that underwent LAR are recruited from the participating hospitals and randomized for either standard treatment or a standardized PFR program. A total of 128 patients should be randomized. Optimal blinding is not possible. Stratification will be done in variable blocks (gender and additional radiotherapy). The primary endpoint is the Wexner incontinence score; secondary endpoints are health-related and fecal-incontinence-related QoL and cost-effectiveness. Baseline measurements take place before randomization. The primary endpoint is measured 3 months after the start of the intervention, with a 1-year follow-up for sustainability research purposes.

Discussion

The results of this study may substantially improve postoperative care for patients with fecal incontinence or anorectal dysfunction after LAR. This section provides insight in the decisions that were made in the organization of this trial.

Trial registration

Netherlands Trial Registration, NTR5469, registered on 03-09-2015.
Protocol FORCE trial V18, 19-09-2019.
Sponsor Radboud University Medical Center, Nijmegen.
Appendix
Available only for authorised users
Literature
1.
Hassan I, Cima RR. Quality of life after rectal resection and multimodality therapy. J Surg Oncol. 2007;96(8):684–92.CrossRef
2.
Camilleri-Brennan J, Ruta DA, Steele RJ. Patient generated index: new instrument for measuring quality of life in patients with rectal cancer. World J Surg. 2002;26(11):1354–9.CrossRef
3.
Vironen JH, Kairaluoma M, Aalto AM, Kellokumpu IH. Impact of functional results on quality of life after rectal cancer surgery. Dis Colon Rectum. 2006;49(5):568–78.CrossRef
4.
Pucciani F. A review on functional results of sphincter-saving surgery for rectal cancer: the anterior resection syndrome. Updat Surg. 2013;65(4):257–63.CrossRef
5.
Bloemen JG, Visschers RG, Truin W, Beets GL, Konsten JL. Long-term quality of life in patients with rectal cancer: association with severe postoperative complications and presence of a stoma. Dis Colon Rectum. 2009;52(7):1251–8.CrossRef
6.
Peeters KC, van de Velde CJ, Leer JW, Martijn H, Junggeburt JM, Kranenbarg EK, et al. Late side effects of short-course preoperative radiotherapy combined with total mesorectal excision for rectal cancer: increased bowel dysfunction in irradiated patients--a Dutch colorectal cancer group study. J Clin Oncol. 2005;23(25):6199–206.CrossRef
7.
Deutekom M, Dobben AC, Dijkgraaf MG, Terra MP, Stoker J, Bossuyt PM. Costs of outpatients with fecal incontinence. Scand J Gastroenterol. 2005;40(5):552–8.CrossRef
8.
Bols EM, Berghmans BC, Hendriks EJ, de Bie RA, Melenhorst J, van Gemert WG, et al. A randomized physiotherapy trial in patients with fecal incontinence: design of the PhysioFIT-study. BMC Public Health. 2007;7:355.CrossRef
9.
Damon H, Siproudhis L, Faucheron JL, Piche T, Abramowitz L, Eleouet M, et al. Perineal retraining improves conservative treatment for faecal incontinence: a multicentre randomized study. Dig Liver Dis. 2014;46(3):237–42.CrossRef
10.
Rao SS. Current and emerging treatment options for fecal incontinence. J Clin Gastroenterol. 2014;48(9):752–64.CrossRef
11.
Laforest A, Bretagnol F, Mouazan AS, Maggiori L, Ferron M, Panis Y. Functional disorders after rectal cancer resection: does a rehabilitation programme improve anal continence and quality of life? Colorectal Dis. 2012;14(10):1231–7.CrossRef
12.
Liu CH, Chen CH, Lee JC. Rehabilitation exercise on the quality of life in anal sphincter-preserving surgery. Hepatogastroenterology. 2011;58(110–111):1461–5.PubMed
13.
Allgayer H, Dietrich CF, Rohde W, Koch GF, Tuschhoff T. Prospective comparison of short- and long-term effects of pelvic floor exercise/biofeedback training in patients with fecal incontinence after surgery plus irradiation versus surgery alone for colorectal cancer: clinical, functional and endoscopic/endosonographic findings. Scand J Gastroenterol. 2005;40(10):1168–75.CrossRef
14.
Kim KH, Yu CS, Yoon YS, Yoon SN, Lim SB, Kim JC. Effectiveness of biofeedback therapy in the treatment of anterior resection syndrome after rectal cancer surgery. Dis Colon Rectum. 2011;54(9):1107–13.CrossRef
15.
Pucciani F, Ringressi MN, Redditi S, Masi A, Giani I. Rehabilitation of fecal incontinence after sphincter-saving surgery for rectal cancer: encouraging results. Dis Colon Rectum. 2008;51(10):1552–8.CrossRef
16.
Snijders HS, van den Broek CB, Wouters MW, Meershoek-Klein Kranenbarg E, Wiggers T, Rutten H, et al. An increasing use of defunctioning stomas after low anterior resection for rectal cancer. Is this the way to go? Eur J Surg Oncol. 2013;39(7):715–20.CrossRef
17.
Chan AW, Tetzlaff JM, Gotzsche PC, Altman DG, Mann H, Berlin JA, et al. SPIRIT 2013 explanation and elaboration: guidance for protocols of clinical trials. Br Med J (Clin Res Ed). 2013;346:e7586.
18.
Borm GF, Fransen J, Lemmens WA. A simple sample size formula for analysis of covariance in randomized clinical trials. J Clin Epidemiol. 2007;60(12):1234–8.CrossRef
19.
Meinds RJ, Timmerman MEW, van Meegdenburg MM, Trzpis M, Broens PMA. Reproducibility, feasibility and validity of the Groningen defecation and fecal continence questionnaires. Scand J Gastroenterol. 2018;53(7):790–6.CrossRef
20.
van Meegdenburg MM, Meinds RJ, Trzpis M, Broens PMA. Subtypes and symptoms of fecal incontinence in the Dutch population: a cross-sectional study. Int J Color Dis. 2018;33(7):919–25.CrossRef
21.
Bols EM, Hendriks HJ, Berghmans LC, Baeten CG, de Bie RA. Responsiveness and interpretability of incontinence severity scores and FIQL in patients with fecal incontinence: a secondary analysis from a randomized controlled trial. Int Urogynecol J. 2013;24(3):469–78.CrossRef
22.
Deutekom M, Terra MP, Dobben AC, Dijkgraaf MG, Felt-Bersma RJ, Stoker J, et al. Selecting an outcome measure for evaluating treatment in fecal incontinence. Dis Colon Rectum. 2005;48(12):2294–301.CrossRef
23.
Hupkens BJP, Breukink SO, Olde Reuver Of Briel C, Tanis PJ, de Noo ME, van Duijvendijk P, et al. Dutch validation of the low anterior resection syndrome score. Colorectal Dis. 2018;20(10):881–7.CrossRef
24.
Voorham JC, De Wachter S, Van den Bos TWL, Putter H, Lycklama ANGA, Voorham-van der Zalm PJ. The effect of EMG biofeedback assisted pelvic floor muscle therapy on symptoms of the overactive bladder syndrome in women: a randomized controlled trial. Neurourol Urodyn. 2017;36(7):1796–803.CrossRef
25.
Rockwood TH, Church JM, Fleshman JW, Kane RL, Mavrantonis C, Thorson AG, et al. Fecal incontinence quality of life scale: quality of life instrument for patients with fecal incontinence. Dis Colon Rectum. 2000;43(1):9–16 discussion −7.CrossRef
26.
Sprangers MA, te Velde A, Aaronson NK. The construction and testing of the EORTC colorectal cancer-specific quality of life questionnaire module (QLQ-CR38). European Organization for Research and Treatment of Cancer Study Group on Quality of Life. Eur J Cancer. 1999;35(2):238–47.CrossRef
27.
Uwer L, Rotonda C, Guillemin F, Miny J, Kaminsky MC, Mercier M, et al. Responsiveness of EORTC QLQ-C30, QLQ-CR38 and FACT-C quality of life questionnaires in patients with colorectal cancer. Health Qual Life Outcomes. 2011;9:70.CrossRef
28.
Lewis SJ, Heaton KW. Stool form scale as a useful guide to intestinal transit time. Scand J Gastroenterol. 1997;32(9):920–4.CrossRef
29.
Dolan P. Modeling valuations for EuroQol health states. Med Care. 1997;35(11):1095–108.CrossRef
30.
Lamers LM, Stalmeier PFM, McDonnell J, Krabbe PFM, Busschbach JJV. Kwaliteit van leven meten in economische evaluaties: het Nederlands EQ-5D-tarief (in Dutch). Ned Tijdschr Geneeskd. 2005;149:1574–8.PubMed
31.
Herdman M, Gudex C, Lloyd A, Janssen M, Kind P, Parkin D, et al. Development and preliminary testing of the new five-level version of EQ-5D (EQ-5D-5L). Qual Life Res. 2011;20(10):1727–36.CrossRef
32.
Bo K BL, Morkved S, van Kampen M. Evidence-based physical therapy for the pelvic floor. Bridging science and clinical practise. 2nd ed. London: Elsevier Churchill Livingstone; 2015. 321–3 p.CrossRef
33.
Visser WS, Te Riele WW, Boerma D, van Ramshorst B, van Westreenen HL. Pelvic floor rehabilitation to improve functional outcome after a low anterior resection: a systematic review. Ann Coloproctol. 2014;30(3):109–14.CrossRef
34.
Bartlett L, Sloots K, Nowak M, Ho YH. Biofeedback for fecal incontinence: a randomized study comparing exercise regimens. Dis Colon Rectum. 2011;54(7):846–56.CrossRef
35.
Heymen S, Scarlett Y, Jones K, Ringel Y, Drossman D, Whitehead WE. Randomized controlled trial shows biofeedback to be superior to pelvic floor exercises for fecal incontinence. Dis Colon Rectum. 2009;52(10):1730–7.CrossRef
36.
Yeap ZH, Simillis C, Qiu S, Ramage L, Kontovounisios C, Tekkis P. Diagnostic accuracy of anorectal manometry for fecal incontinence: a meta-analysis. Acta Chir Belg. 2017;117(6):347–55.CrossRef
37.
Broens PMA, Jonker JE, Trzpis M. The puborectal continence reflex: a new regulatory mechanism controlling fecal continence. Int J Color Dis. 2018;33(5):627–33.CrossRef
38.
Broens PM, Penninckx FM, Ochoa JB. Fecal continence revisited: the anal external sphincter continence reflex. Dis Colon Rectum. 2013;56(11):1273–81.CrossRef
Metadata
Title
Pelvic floor rehabilitation to improve functional outcome and quality of life after surgery for rectal cancer: study protocol for a randomized controlled trial (FORCE trial)
Authors
A.J. Kalkdijk-Dijkstra
J.A.G. van der Heijden
H.L. van Westreenen
P.M.A. Broens
M. Trzpis
J.P.E.N. Pierie
B.R. Klarenbeek
FORCE Trial Group
Publication date
01-12-2020
Publisher
BioMed Central
Published in
Trials / Issue 1/2020
Electronic ISSN: 1745-6215
DOI
https://doi.org/10.1186/s13063-019-4043-7

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