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

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorUniversity Hospital, Antwerp

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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.

Disqualifiers

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

Trial design

Design model

Sequential

Treatments tested in this trial

  • Questionnaire

    Other intervention

    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

Treatment groups

100 Participants
are divided into 2 treatment groups
Group A: Upfront surgeryOther 1 intervention
Group B: Neo-adjuvant therapyOther 1 intervention

Trial outcomes

Primary outcomes

1

The evolution of the COREFO-score (Colorectal Functional Outcome questionnaire) at 2 years after rectal surgery compared to baseline (absolute difference) will be examined

27 questions on 5-point Likert scale Higher score = worse bowel function

Time frame
2 years from when rectal resection or stoma reversal was performed

Secondary outcomes

1

Evolution of LARS-score (low anterior resection syndrome) at 2 years after rectal surgery compared to baseline (absolute difference)

0-20 = no LARS 21-29 = minor LARS 30-42 = major LARS

Time frame
2 years from when rectal resection or stoma reversal was performed
2

The evolution of the LARS-score (low anterior resection syndrome) at 2 years after rectal surgery compared to baseline (relative difference) will be examined.

0-20 = no LARS 21-29 = minor LARS 30-42 = major LARS

Time frame
2 years from when rectal resection or stoma reversal was performed
3

The evolution of the COREFO-score (Colorectal Functional Outcome questionnaire) at 2 years after rectal surgery compared to baseline (relative difference) will be examined

27 questions on 5-point Likert scale Higher score = worse bowel function (min 0 - max 100)

Time frame
2 years from when rectal resection or stoma reversal was performed
4

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.

0-20 no LARS 21-29 minor LARS 30-42 major LARS (min 0 - max 42)

Time frame
2 years from when rectal resection or stoma reversal was performed

Other outcomes

1

Gender

Male, female, other

Time frame
Baseline
2

Year of birth

Year of birth

Time frame
Baseline
3

Age

Age at diagnosis and at surgery

Time frame
Baseline to date of surgery
4

Hospital admission data

Length of stay in days (date of admission for rectal resection until date of dismission)

Time frame
After rectal resection

Sponsors and contacts

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