Skip to main content

Advertisement

SpringerLink
Log in

Patient Reported Outcomes following Cancer of the Rectum (PROCaRe): protocol of a prospective multicentre international study

  • Original Article
  • Published:
Techniques in Coloproctology Aims and scope Submit manuscript

Abstract

Purpose

Rectal cancer surgery presents challenges in achieving good oncological results and preserving functional outcomes. Different surgical approaches, including open, laparoscopic, robotic and transanal techniques, have been employed, but there is a lack of consensus on the optimal approach, particularly in terms of functional results. This study aims to assess bowel function and to compare outcomes of patients that had undergone surgery for mid-low rectal cancer across different surgical approaches.

Method

This is an international, multicentre, prospective cohort study. Inclusion criteria are patients diagnosed with rectal cancer below the peritoneal reflection, eligible for different surgical approaches for total mesorectal excision (TME). Data will be collected using validated questionnaires assessing bowel, sexual and urinary function, and quality of life (QOL). Secondary outcomes include short-term postoperative results. Data will be collected at baseline and 6, 12 and 24 months after index surgery or stoma reversal surgery.

Conclusion

This study will provide insights into the impact of different approaches for TME on bowel, sexual and urinary function, and overall QOL of patients undergoing rectal cancer surgery. The findings will provide important information to optimise the surgical strategy and to improve patient care in this population.

Trial registration

ClinicalTrials.gov, NCT04936581 (registered 23 June 2021).

This is a preview of subscription content, log in via an institution to check access.

Access this article

Log in via an institution

Price excludes VAT (USA)
Tax calculation will be finalised during checkout.

Instant access to the full article PDF.

Institutional subscriptions

Fig. 1

Similar content being viewed by others

Data availability

The datasets used and/or analysed during the current study will be available from the corresponding author on request.

References

  1. Guillou PJ, Quirke P, Thorpe H et al (2005) Short-term endpoints of conventional versus laparoscopic-assisted surgery in patients with colorectal cancer (MRC CLASICC trial): multicentre, randomised controlled trial. Lancet 365:1718–1726

    Article  PubMed  Google Scholar 

  2. Bonjer HJ, Deijen CL, Haglind E, COLOR II Study Group (2015) A randomized trial of laparoscopic versus open surgery for rectal cancer. N Engl J Med 2015(373):194

    Google Scholar 

  3. Heald RJ (1988) The ‘Holy Plane’ of rectal surgery. J R Soc Med 81:503–508

    Article  CAS  PubMed  PubMed Central  Google Scholar 

  4. European Society of Coloproctology (ESCP) collaborating group (2018) An international multicentre prospective audit of elective rectal cancer surgery; operative approach versus outcome, including transanal total mesorectal excision (taTME). Colorectal Dis 20(Suppl 6):33–46

    Article  Google Scholar 

  5. Sylla P, Rattner DW, Delgado S, Lacy AM (2010) NOTES transanal rectal cancer resection using transanal endoscopic microsurgery and laparoscopic assistance. Surg Endosc 24:1205–1210

    Article  PubMed  Google Scholar 

  6. Wasmuth HH, Faerden AE, Myklebust TÅ et al (2020) Transanal total mesorectal excision for rectal cancer has been suspended in Norway. Br J Surg 107:121–130

  7. Van Der Heijden JAG, Qaderi SM, Verhoeven R et al (2012) Transanal total mesorectal excision and low anterior resection syndrome. Br J Surg 108(8):991–997

  8. Sun R, Dai Z, Zhang Y, Lu J, Zhang Y, Xiao Y (2021) The incidence and risk factors of low anterior resection syndrome (LARS) after sphincter-preserving surgery of rectal cancer: a systematic review and meta-analysis. Support Care Cancer 1:3. https://doi.org/10.1007/s00520-021-06326-2

    Article  Google Scholar 

  9. Burch J, Taylor C, Wilson A, Norton C (2021) Symptoms affecting quality of life after sphincter-saving rectal cancer surgery: a systematic review. Eur J Oncol Nurs 52:101934

    Article  PubMed  Google Scholar 

  10. Christensen P, Im Baeten C, Espín-Basany E et al (2021) Management guidelines for low anterior resection syndrome-the MANUEL project. Colorectal Dis 23:461–475

    Article  PubMed  PubMed Central  Google Scholar 

  11. Li K, He X, Tong S, Zheng Y (2021) Risk factors for sexual dysfunction after rectal cancer surgery in 948 consecutive patients: a prospective cohort study. Eur J Surg Oncol 47:2087–2092

    Article  PubMed  Google Scholar 

  12. Calvert M, Kyte D, Mercieca-Bebber R, Slade A, Chan A-W, King MT (2018) Guidelines for inclusion of patient-reported outcomes in clinical trial protocols the SPIRIT-PRO Extension. JAMA 319:483–494

  13. Keane C, Fearnhead NS, Bordeianou L et al. International consensus definition of low anterior resection syndrome. https://doi.org/10.1111/codi.14957

  14. Emmertsen KJ, Laurberg S (2012) 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 255:922–928

    Article  PubMed  Google Scholar 

  15. Vaizey CJ, Carapeti E, Cahill JA, Kamm MA (1999) Prospective comparison of faecal incontinence grading systems. Gut 44:77–80

    Article  CAS  PubMed  PubMed Central  Google Scholar 

  16. Rosen RC, Riley A, Wagner G, Osterloh IH, Kirkpatrick J, Mishra A (1997) The international index of erectile function (IIEF): a multidimensional scale for assessment of erectile dysfunction. Urology 49:822–830

    Article  CAS  PubMed  Google Scholar 

  17. Rosen R, Brown C, Heiman J et al (2000) The female sexual function index (FSFI): a multidimensional self-report instrument for the assessment of female sexual function. J Sex Marital Ther 26:191–208

    Article  CAS  PubMed  Google Scholar 

  18. Barry MJ, Fowler FJ, O’Leary MP et al (1992) The American Urological Association symptom index for benign prostatic hyperplasia. The Measurement Committee of the American Urological Association. J Urol 148:1549–1557

    Article  CAS  PubMed  Google Scholar 

  19. Bjordal K, de Graeff A, Fayers PM et al (2000) A 12 country field study of the EORTC QLQ-C30 (version 3.0) and the head and neck cancer specific module (EORTC QLQ-H&N35) in head and neck patients. EORTC quality of life group. Eur J Cancer 36:1796–1807

    Article  CAS  PubMed  Google Scholar 

  20. Gujral S, Conroy T, Fleissner C et al (2007) Assessing quality of life in patients with colorectal cancer: an update of the EORTC quality of life questionnaire. Eur J Cancer 43:1564–1573

    Article  CAS  PubMed  Google Scholar 

  21. Bryant CLC, Lunniss PJ, Knowles CH, Thaha MA, Chan CLH (2012) Anterior resection syndrome. Lancet Oncol 13:e403–e408

    Article  PubMed  Google Scholar 

  22. Sun W, Dou R, Chen J et al (2019) Impact of long-course neoadjuvant radiation on postoperative low anterior resection syndrome and quality of life in rectal cancer: post hoc analysis of a randomized controlled trial. Ann Surg Oncol 26:746–755

    Article  PubMed  Google Scholar 

  23. Croese AD, Lonie JM, Trollope AF, Vangaveti VN, Ho Y-H (2018) A meta-analysis of the prevalence of low anterior resection syndrome and systematic review of risk factors. Int J Surg 56:234–241

    Article  PubMed  Google Scholar 

  24. van der Heijden JW, Koëter T et al (2020) Functional complaints and quality of life after transanal total mesorectal excision: a meta-analysis. Br J Surg. https://doi.org/10.1002/bjs.11566

    Article  PubMed  Google Scholar 

  25. Choy KW, Yang TWW, Prabhakaran S, Heriot AG, Kong JC, Warrier SK (2021) Comparing functional outcomes between transanal total mesorectal excision (taTME) and laparoscopic total mesorectal excision (LaTME) for rectal cancer: a systematic review and meta-analysis. Int J Colorectal Dis. https://doi.org/10.1007/s00384-021-03849-2

    Article  PubMed  Google Scholar 

  26. Li X, Wang T, Yao L et al (2017) The safety and effectiveness of robot-assisted versus laparoscopic TME in patients with rectal cancer. Medicine 96:e7585

    Article  PubMed  PubMed Central  Google Scholar 

  27. Kim JY, Kim N-K, Lee KY, Hur H, Min BS, Kim JH (2012) A comparative study of voiding and sexual function after total mesorectal excision with autonomic nerve preservation for rectal cancer: laparoscopic versus robotic surgery. Ann Surg Oncol 19:2485–2493

    Article  PubMed  Google Scholar 

  28. Kim HJ, Choi G-S, Park JS, Park SY, Yang CS, Lee HJ (2018) The impact of robotic surgery on quality of life, urinary and sexual function following total mesorectal excision for rectal cancer: a propensity score-matched analysis with laparoscopic surgery. Colorectal Dis 20:O103–O113

    Article  CAS  PubMed  Google Scholar 

  29. Park SY, Choi G-S, Park JS, Kim HJ, Ryuk J-P, Yun S-H (2014) Urinary and erectile function in men after total mesorectal excision by laparoscopic or robot-assisted methods for the treatment of rectal cancer: a case-matched comparison. World J Surg 38:1834–1842

    Article  PubMed  Google Scholar 

  30. Andolfi C, Umanskiy K (2019) Appraisal and current considerations of robotics in colon and rectal surgery. J Laparoendosc Adv Surg Tech A 29:152–158

    Article  PubMed  Google Scholar 

  31. Alimova I, Chernyshov S, Nagudov MA, Rybakov E (2021) Comparison of oncological and functional outcomes and quality of life after transanal or laparoscopic total mesorectal excision for rectal cancer: a systematic review and meta-analysis. Tech Coloproctol. https://doi.org/10.1007/s10151-021-02420-z

    Article  PubMed  Google Scholar 

Download references

Funding

No funding.

Author information

Authors and Affiliations

  1. Colorectal Surgery Unit, University Hospital Gregorio Marañon, Madrid, Spain

    Patricia Tejedor

  2. Colorectal Surgery Unit, University Clinic of Navarre, Pamplona and Madrid, Spain

    Jorge Arredondo & Carlos Pastor

  3. Colorectal Surgery, Vall d’Hebron University Hospital, Universitat Autonoma de Barcelona UAB, Barcelona, Spain

    Gianluca Pellino

  4. Department of Advanced Medical and Surgical Sciences, Università Degli Studi Della Campania “Luigi Vanvitelli”, Naples, Italy

    Gianluca Pellino

  5. Italian Surgical Research Group (ItSURG), Rende, Italy

    Gianluca Pellino & Francesco Pata

  6. Department of Pharmacy, Health and Nutritional Sciences, University of Calabria, Rende, Italy

    Francesco Pata

Authors
  1. Patricia Tejedor
    View author publications

    You can also search for this author in PubMed Google Scholar

  2. Jorge Arredondo
    View author publications

    You can also search for this author in PubMed Google Scholar

  3. Gianluca Pellino
    View author publications

    You can also search for this author in PubMed Google Scholar

  4. Francesco Pata
    View author publications

    You can also search for this author in PubMed Google Scholar

  5. Carlos Pastor
    View author publications

    You can also search for this author in PubMed Google Scholar

Consortia

on behalf of the PROCaRe study group

Contributions

PT and CP contributed equally in analysing the data and writing the manuscript. The rest of the authors critically revised the paper for important intellectual content. All authors have contributed to the work and agreed on the final version.

Corresponding author

Correspondence to Patricia Tejedor.

Ethics declarations

Conflict of interest

The authors declare that they have no conflict of interest.

Ethical approval

All procedures performed in studies involving humans were in accordance with ethical standards of the institutional research committee and the 1964 Helsinki declaration and its later amendments.

Informed consent

Informed consent was obtained from all participants included in the study.

Additional information

Publisher's Note

Springer Nature remains neutral with regard to jurisdictional claims in published maps and institutional affiliations.

Supplementary Information

Rights and permissions

Springer Nature or its licensor (e.g. a society or other partner) holds exclusive rights to this article under a publishing agreement with the author(s) or other rightsholder(s); author self-archiving of the accepted manuscript version of this article is solely governed by the terms of such publishing agreement and applicable law.

Reprints and permissions

About this article

Check for updates. Verify currency and authenticity via CrossMark

Cite this article

Tejedor, P., Arredondo, J., Pellino, G. et al. Patient Reported Outcomes following Cancer of the Rectum (PROCaRe): protocol of a prospective multicentre international study. Tech Coloproctol 27, 1345–1350 (2023). https://doi.org/10.1007/s10151-023-02865-4

Download citation

  • Received:

  • Accepted:

  • Published:

  • Issue Date:

  • DOI: https://doi.org/10.1007/s10151-023-02865-4

Keywords

Search

Navigation