Ann Surg. 2022 Jul 1;276(1):38-45.doi: 10.1097/SLA.0000000000005353. Epub 2021 Dec 28.

J A G van der Heijden ¹, A J Kalkdijk-Dijkstra ^1 2, J P E N Pierie ^3 4, H L van Westreenen ⁵, P M A Broens ², B R Klarenbeek ¹, FORCE trial group

Collaborators

• FORCE trial group: 

Jhw de Wilt, Mwj Stommel, Aja Bremers, C Rosman, P R de Reuver, Saw Bouwense, B M van der Kolk, L M Garms, K Meerten-van den Belt, Mrm Olde Hartman-Hofste, Jwm Peters, L Olsder, I Huizing, M Trzpis, Ejb Furnee, K Havenga, Phj Hemmer, B van Etten, A Koop, L van der Heide, D Kamphuis, S A Koopal, C Hoff, H Eker, Hhm Junte, Ijh Schoenaker, S Quaedackers, M J Bos, H Gardien, T C van Sprundel, P D de Vries, J F Ashruf, L Geurts, I Nielen, J Pfeil, M van Ark, S W Polle, B Hansson, F Polat, H de Vries, E Ten Berge-Groen, A K Talsma, R Bosker, E Veurink, M Papa, Ajg Maaskant-Braat, Fjc van den Broek, Wkg Leclercq, G D Slooter, F Caers, M Boeijen, R van den Broek, K van Schaik, D K Wasowicz-Kemps, B S Langenhoff, M J van den Bogaard, J van der Sluis, D Arisz, S Bruinsma, D A Hess, E J Mulder, B Wiering, S Kok, J Woltering, B Raap-van Sleuwen, L Schoonderwoerd, D Hendriks, N van den Elzen, I van de Laak, M Valk, W van der Meij, B J van Wely, M J van Hoogstraten, M van der Sluis, I Paulusma, Mjw Mollers, R Looijen, Hcj van der Mijle, Ita Pereboom, Pmc Tijink-Callenbach, R A Schasfoort, S J van der Hagen, W van de Meer, M Lubberink, M van Haskera, F Wit, M Jeeninga, R Ten Hoeve, Fcw Slootmans, B Inberg, L de Nes, D Toonen, M A Wilmsen, O Buyne, F Ferenschild, M de Vries, C Adamse, B L Hettema-Beets, M K Goudswaard, M van der Velde, D W Elving, R E Arends-Smit, J R Buiter, I van der Itte-van Aerle, K Jansma, L Kooistra, S Lohof-Venema, M R Kruijer, G Dijkstra, M A van der Erf-Elling, V Kats-de Boer, A M Rinsema, M Haarlemmer-Lutjeboer, A van der Vegt, Smh Berends-Pors, A J Ponstein, G Klaassen, A M Nieuwint, M Veninga-Jansen, V Dries-Jansen, F J Arends, N E Stellingwerf-Goinga, N G Overmars, H van Asma, K Beverdam, Mjac Ploumen, M Tijhuis, A H Visser Duiven, M Former, Mal Smans-Kaal, Cmj Vorsterman van Oijen-Linthorst, N N Hovels-Kamp, L R Vorsteveld, N Vermeulen, A Alkemade-van Veghel, L J Steentjes, Hgm Cornelisse-Theunissen, J Strijbosch, S Sniekers, Jma Oerlemans-van Oijen, Hmj Hoefnagels, Cjda Sniekers, S Biemans, Y Bomert-Wendt, Hgm van Gaal, Ahcw Smulders, W Adams, J M Kappen, A M Vermeltfoort-Jansen, Mgc Zegger, C Vrielink, H M Slotman, Njh Claessens, Awm Manders-de Groot, Ctpg van Beuzekom-van der Vorst, Mwc Swinkels-Nijssen, P van Oeveren, Jpf van Leeuwen-Nellestijn, M Bleijenberg, Jjf Valenteyn-Hidden, M G van Rutten-de Groot, M van den van der Heijden, Nieuwenhuizen, P G Boorsma, N Broodman, M E Elling, E Bokkers-Engelen, G H Hilhorst-Droppers, Hjc Mein, M Gielen

Author information

¹Department of Surgery, Radboud University Medical Center, Nijmegen, the Netherlands.

²Department of Surgery, University Medical Center Groningen, Groningen, the Netherlands.

³Post Graduate School of Medicine (PGSOM), University Medical Center Groningen and University of Groningen, Groningen, the Netherlands.

⁴Department of Surgery, Medical Center Leeuwarden, Leeuwarden, the Netherlands.

⁵Department of Surgery, Isala Clinics, Zwolle, the Netherlands.

Abstract

Objective: To investigate the effects of PFR after LAR compared to usual care without PFR.

Summary of background data: Functional complaints, including fecal incontinence, often occur after LAR for rectal cancer. Controversy exists about the effectiveness of PFR in improving such postoperative functional outcomes.

Methods: This was a multicenter, randomized controlled trial involving 17 Dutch centers. Patients after LAR for rectal cancer were randomly assigned (1:1) to usual care or PFR and stratified by sex and administration of neoadjuvant therapy. Selection was not based on severity of complaints at baseline. Baseline measurements were taken 3 months after surgery without temporary stoma construction or 6 weeks after stoma closure. The primary outcome measure was the change in Wexner incontinence scores 3 months after randomization. Secondary outcomes were fecal incontinence-related quality of life, colorectal-specific quality of life, and the LARS scores.

Results: Between October 2017 and March 2020, 128 patients were enrolled and 106 randomly assigned (PFR n = 51, control n = 55); 95 patients (PFR n = 44, control n = 51) were assessable for final analysis. PFR did not lead to larger changes in Wexner incontinence scores in nonselected patients after LAR compared to usual care [PFR: -2.3, 95% confidence interval (CI) -3.3 to -1.4, control: -1.3, 95% CI -2.2 to -0.4, P = 0.13]. However, PFR was associated with less urgency at follow-up (odds ratio 0.22, 95% CI 0.06-0.86). Patients without near-complete incontinence reported larger Wexner score improvements after PFR (PFR: -2.1, 95% CI -3.1 to -1.1, control: -0.7, 95% CI -1.6 to 0.2, P = 0.045). For patients with at least moderate incontinence PFR resulted in relevant improvements in all fecal incontinence-related quality of life domains, while the control group deteriorated. These improvements were even larger when patients with near-complete incontinence were excluded. No serious adverse PFR-related events occurred.

Conclusion: No benefit was found of PFR in all patients but several subgroups were identified that did benefit from PFR, such as patients with urgency or with at least moderate incontinence and no near-complete incontinence. A selective referral policy (65%-85% of all patients) is suggested to improve postoperative functional outcomes for patients after LAR for rectal cancer.

Trial registration: Netherlands Trial Registration, NTR5469, registered on 3 September 2015.