ProLARS Trial: Prospective Longitudinal Follow-up of Low Anterior Resection Syndrome (LARS) and COREFO Score After Rectum Surgery in Patients Undergoing Upfront Surgery or Different Neo-adjuvant Treatment Regimens

Обзор

OBJECTIVE Low anterior resection syndrome (LARS) is a term for functional bowel complaints occurring after low anterior resection. Symptoms can range from faecal incontinence and frequent loose stools to urgency and incomplete emptying with great impact on quality of life. Little is known about the longitudinal evolution of LARS and the impact of different schedules of neoadjuvant chemoradiotherapy combined with surgery. The investigators aim to investigate the incidence and evolution of functional bowel complaints in function of different neoadjuvant treatment regimens, type of surgery and adjuvant therapy in patients who undergo surgery for rectal cancer. The investigators focus on following objectives: evolution of LARS- and COREFO-scores per treatment regimen and their impact on work incapacity; identification of possible risk factors potentially related to functional outcome; monitoring and treatment of LARS. METHODS This will be a multicentre prospective interventional study. The study population will consist of adult patients with rectal cancer, regardless of any neo-adjuvant therapy. Patients will be included for 5 years with a 2 year postoperative follow-up. Interim analysis will be made after 2 years of inclusion. Patients with intellectual disability or clinical colon obstruction are excluded. Automated online questionnaires including LARS and COREFO scores, incapacity for work and defecation quality will be sent at different time points (figure 1) using REDCap. RESULTS and CONCLUSIONS Longitudinal change of LARS- and COREFO-scores will be visually summarized. Patient, disease or procedure specific risk factors will be assessed as well. LARS is proven to be the principal postoperative problem after rectal surgery. If the investigators can predict the severity of LARS (minor or major LARS), this can be extremely helpful in deciding whether to perform a sphincter-sparing resection or a rectal amputation instead. Furthermore, the investigators want to offer perspective to patients who are susceptible to a disturbed postoperative bowel function.

Вмешательства

• Другое Questionnaire
  Online questionnaire regarding LARS- and COREFO-scores, quality of defecation process, incapacity for work and initiation of treatment for potential LARS at different moments in time

Первичные конечные точки

• The evolution of the COREFO-score (Colorectal Functional Outcome questionnaire) at 2 years after rectal surgery compared to baseline (absolute difference) will be examined [Срок оценки: 2 years from when rectal resection or stoma reversal was performed]

Вторичные конечные точки (12)

• Evolution of LARS-score (low anterior resection syndrome) at 2 years after rectal surgery compared to baseline (absolute difference) [Срок оценки: 2 years from when rectal resection or stoma reversal was performed]
• The evolution of the LARS-score (low anterior resection syndrome) at 2 years after rectal surgery compared to baseline (relative difference) will be examined. [Срок оценки: 2 years from when rectal resection or stoma reversal was performed]
• The evolution of the COREFO-score (Colorectal Functional Outcome questionnaire) at 2 years after rectal surgery compared to baseline (relative difference) will be examined [Срок оценки: 2 years from when rectal resection or stoma reversal was performed]
• The evolution of the LARS-score (low anterior resection syndrome) in the absence of baseline data will be examined as well (absolute difference), comparing 2-year outcome to earliest results. [Срок оценки: 2 years from when rectal resection or stoma reversal was performed]
• The evolution of the LARS-score (low anterior resection syndrome) in the absence of baseline data will be examined as well (relative difference), comparing 2-year outcome to earliest results. [Срок оценки: 2 years from when rectal resection or stoma reversal was performed]
• The evolution of the COREFO-score (Colorectal Functional Outcome questionnaire) in the absence of baseline data will be examined as well (absolute difference), comparing 2-year outcome to earliest results. [Срок оценки: 2 years from when rectal resection or stoma reversal was performed]
• The evolution of the COREFO-score (Colorectal Functional Outcome questionnaire) in the absence of baseline data will be examined as well (relative difference), comparing 2-year outcome to earliest results. [Срок оценки: 2 years from when rectal resection or stoma reversal was performed]
• LARS-score (low anterior resection syndrome) score at diagnosis [Срок оценки: At diagnosis = baseline]
• COREFO-score at diagnosis (Colorectal Functional Outcome questionnaire) [Срок оценки: At diagnosis = baseline]
• LARS-score (low anterior resection syndrome) after neo-adjuvant therapy [Срок оценки: After neo-adjuvant therapy (up to 6 months from baseline)]
• COREFO-score after neo-adjuvant therapy (Colorectal Functional Outcome questionnaire) [Срок оценки: After neo-adjuvant therapy (up to 6 months from baseline)]
• LARS-score (low anterior resection syndrome) shortly prior to surgery when there is a delay of 4 or more weeks after finishing neoadjuvant therapy [Срок оценки: 2 days prior to surgery]

Критерии участия

Критерии включения

• 18 years or older.
• Diagnosis of rectal cancer, discussed at the multidisciplinary consultation, with the intention to perform a sphincter preserving total mesorectal excision (TME) or partial mesorectal excision (PME), regardless of the need of neoadjuvant treatment.

Критерии исключения

• History of inflammatory bowel disease (Crohn's disease, ulcerative colitis) due to often persistent bowel complaints and therefore distorted baseline and follow-up data.
• Dementia or intellectual disability.
• Patients who are obstructive and in need a decompressive stoma or rectal stenting due to the lack of baseline data as they are often admitted to the hospital in an urgent setting

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Нерандомизированное

Модель

Последовательный дизайн

Маскирование

Открытое

Основная цель

Диагностика

Центры проведения

Бельгия · 1 центр

• University Hospital Antwerp — Edegem

Идентификаторы

NCT: NCT07339904 · 6510

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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