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

NCT07339904 | Recruiting

• 1 other identifier: 6510
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Rectal Adenocarcinoma; Rectal Resection; Low Anterior Resection; Total Mesorectal Excision; LARS - Low Anterior Resection Syndrome

Keywords

LARS; Rectal resection; Total mesorectal excision; Low anterior resection; Rectal carcinoma

Outcome Measures

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

  2 years from when rectal resection or stoma reversal was performed

Secondary Outcomes (18)

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

  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.

  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

  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.

  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.

  2 years from when rectal resection or stoma reversal was performed

Other Outcomes (32)

• Gender

  Baseline

• Year of birth

  Baseline

• Age

  Baseline to date of surgery

Study Arms (2)

Upfront surgery

OTHER

Patients who undergo rectal resection without neo-adjuvant therapy

Other: Questionnaire

Neo-adjuvant therapy

OTHER

Patients who receive neo-adjuvant therapy before undergoing rectal surgery

Other: Questionnaire

Interventions

Questionnaire OTHER

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

Neo-adjuvant therapy; Upfront surgery

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• University Hospital, Antwerp: lead

Study Sites (1)

University Hospital Antwerp

Edegem, Antwerp, 2650, Belgium

RECRUITING

MeSH Terms

Conditions

Rectal Neoplasms; Low Anterior Resection Syndrome

Interventions

Surveys and Questionnaires

Condition Hierarchy (Ancestors)

Colorectal Neoplasms; Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Intestinal Diseases; Rectal Diseases; Colonic Diseases; Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Data Collection; Epidemiologic Methods; Investigative Techniques; Health Care Evaluation Mechanisms; Quality of Health Care; Health Care Quality, Access, and Evaluation; Public Health; Environment and Public Health

Study Officials

• Niels Komen, MD PhD

  University Hospital, Antwerp

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Niels Komen, MD PhD

CONTACT

+32 3 821 30 00; niels.komen@uza.be

Juul Meurs, MD

CONTACT

+32476617623; juul.meurs@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SEQUENTIAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD, PhD, Head of the Abdominal Surgery Department, Principal Investigator, Clinical Professor

Model Details: Patients receive online questionnaires regarding LARS- and COREFO-scores

Study Record Dates

• First Submitted: April 12, 2025
• First Posted: January 14, 2026
• Study Start: August 26, 2024
• Primary Completion (Estimated): August 1, 2029
• Study Completion (Estimated): August 1, 2029
• Last Updated: January 14, 2026

Record last verified: 2025-12

Locations

BE (1)