Acronym
FORCE
Name of the study
Pelvic Floor Rehabilitation to improve functional Outcome and quality of life after surgery for Rectal CancEr: a randomized controlled trial.
Researchers and contact information
Coordinating investigator
Joost van der Heijden, PhD candidate
Department of surgery
Radboudumc, Nijmegen
T: +31657379606 / Email: joost.vanderheijden@radboudumc.nl
Pelvic floor expert and researcher
Mevr. A.J. Kalkdijk, PhD candidate and Investigator Anorectal Function Center.
University Medical Center Groningen
T: 050-3616161 / Email: Jenneke.Dijkstra-Kalkdijk@radboudumc.nl
Principal investigators
Dr. B.R. Klarenbeek, surgeon and project leader
Radboud University Medical Center
T: 024 3611111 / Email: b.r.klarenbeek@umcg.nl
Dr. P.M.A. Broens, surgeon
University Medical Center Groningen
T: 050-3616161 / Email: p.m.a.broens@umcg.nl
Prof. dr. J.P.E.N. Pierie, surgeon
University Medical Center Groningen (UMCG) and Medical Center Leeuwarden (MCL)
T: 050-3616161 / Email: j.p.e.n.pierie@umcg.nl
Dr. H.L. van Westreenen , surgeon
Isala Klinieken
T: 038 424 5000 / Email: h.l.van.westreenen@isala.nl
Summary study
Rationale: Up to 90% of the patients develop anorectal dysfunctions after a low anterior resection (LAR). Especially fecal incontinence (FI) has major impact on physical, psychological, social and emotional functioning of the patient. Alongside, fecal incontinence has a substantial impact on the National Healthcare budget with over €2000 spent per patient per year. There is no standardized treatment protocol to help this group of patients. Current treatment is focused on symptom relief and consists mostly of pharmacotherapy (bulking agents and/or anti-diarrhea medication). Another treatment option is Pelvic Floor Rehabilitation (PFR); one of the most important treatments for fecal incontinence in general, with success rates of 50-80%.
The FORCE-trial randomizes rectal cancer patients after sphincter saving rectal resection for either a standardized pelvic floor rehabilitation program or standard treatment, with the aim to reduce complaints and costs of fecal incontinence.
Objective:
The primary objective is to evaluate the effect of PFR compared to standard treatment on fecal incontinence in patients after LAR, by measuring the Wexner-score. The secondary objective are to explore the effect of demographic, surgical and oncologic parameters on the development of fecal incontinence in relation to PFR and to evaluate the effect of PFR on the quality of life. Also we will analyze the cost-effectiveness of full implementation of PFR compared to standard treatment in treating and preventing FI in patients after LAR.
A follow-up of 1 year will be used to evaluate the potential sustainability of PFR.
Study design:
The FORCE-trial is a multicentre, two-armed, randomized, clinical trial.
Study population:
168 rectal cancer patients after sphincter saving surgery (low anterior resection or LAR) will be recruited from the participating hospitals.
Inclusion criteria:
- Patients underwent low anterior resection for rectal carcinoma.
- Age ≥ 18 years.
- Being able to understand enough Dutch to fill in the Dutch checklists/questionnaires.
Exclusion criteria:
- Comorbidity of proctitis, colitis ulcerosa and Crohn disease.
- Locally advanced (T4) tumours indicated for extensive resection (beyond TME).
- Previous history of pelvic radiation (other than present rectal cancer).
- Pelvic Floor Rehabilitation during last 6 months.
- Life expectancy < 1 year.
- Mentally or physically not able to undergo PFR.
Intervention
Three months after LAR or six weeks after stoma closure the patients from the intervention group will receive, add-on to the standard treatment, a standardized pelvic floor rehabilitation program. This program consist of 12 sessions performed during 3 months, performed by registered pelvic floor physiotherapists, and include muscle training, myofeedback, electrostimulation and rectal balloon training.
Participating centers:
Radboudumc, Nijmegen
Medisch Centrum Leeuwaren, Leeuwarden
Isala Klinieken, Zwolle
Universitair Medisch Centrum Groningen, Groningen
Canisius Wilhelmina Ziekenhuis, Nijmegen
Ommelander Ziekenhuis Groningen, lokatie Delfzijl
Antoniusziekenhuis, Sneek
Nij Smellinghe, Drachten
Bernhoven, Uden
Máxima Medisch Centrum, Veldhoven/Eindhoven
Deventer Ziekenhuis, Deventer
Slingeland ziekenhuis, Doetinchem
Treant zorggroep, Emmen
Tjongerschans ziekenhuis, Heerenveen
Elisabeth-TweeSteden Ziekenhuis, Tilburg
Documents
For the most up-to-date version of the protocol and patient information, see: www.forcetrial.nl