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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Upfront surgery | Other | Patients who undergo rectal resection without neo-adjuvant therapy |
|
| Neo-adjuvant therapy | Other | Patients who receive neo-adjuvant therapy before undergoing rectal surgery |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Gender | Male, female, other | Baseline |
| Year of birth | Year of birth | Baseline |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Niels Komen, MD PhD | Contact | +32 3 821 30 00 | niels.komen@uza.be | |
| Juul Meurs, MD | Contact | +32476617623 | juul.meurs@gmail.com |
| Name | Affiliation | Role |
|---|---|---|
| Niels Komen, MD PhD | University Hospital, Antwerp | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University Hospital Antwerp | Recruiting | Edegem | Antwerp | 2650 | Belgium |
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Patients receive online questionnaires regarding LARS- and COREFO-scores
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0-20 = no LARS 21-29 = minor LARS 30-42 = major LARS |
| 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 | 27 questions on 5-point Likert scale Higher score = worse bowel function (min 0 - max 100) | 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. | 0-20 no LARS 21-29 minor LARS 30-42 major LARS (min 0 - max 42) | 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. | 0-20 no LARS 21-29 minor LARS 30-42 major LARS (min 0 - max 42) | 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. | 27 questions on 5-point Likert scale Higher score = worse bowel function (min 0 - max 100) | 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. | 27 questions on 5-point Likert scale Higher score = worse bowel function (min 0 - max 100) | 2 years from when rectal resection or stoma reversal was performed |
| LARS-score (low anterior resection syndrome) score at diagnosis | 0-20 no LARS 21-29 minor LARS 30-42 major LARS (min 0 - max 42) LARS = low anterior resection syndrome Using a questionnaire Unit = mean score (0-42) | At diagnosis = baseline |
| COREFO-score at diagnosis (Colorectal Functional Outcome questionnaire) | 27 questions on 5-point Likert scale Higher score = worse bowel function (min 0 - max 100) COREFO = Colorectal Functional Outcome questionnaire Using a questionnaire Unit = mean score (0-100) | At diagnosis = baseline |
| LARS-score (low anterior resection syndrome) after neo-adjuvant therapy | 0-20 no LARS 21-29 minor LARS 30-42 major LARS (min 0 - max 42) LARS = low anterior resection syndrome Using a questionnaire Unit = mean score (0-42) | After neo-adjuvant therapy (up to 6 months from baseline) |
| COREFO-score after neo-adjuvant therapy (Colorectal Functional Outcome questionnaire) | 27 questions on 5-point Likert scale Higher score = worse bowel function (min 0 - max 100) COREFO = Colorectal Functional Outcome questionnaire Using a questionnaire Unit = mean score (0-100) | 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 | 0-20 no LARS 21-29 minor LARS 30-42 major LARS (min 0 - max 42) LARS = low anterior resection syndrome Using a questionnaire Unit = mean score (0-42) | 2 days prior to surgery |
| COREFO-score (Colorectal Functional Outcome questionnaire) shortly prior to surgery when there is a delay of 4 or more weeks after finishing neoadjuvant therapy | 27 questions on 5-point Likert scale Higher score = worse bowel function (min 0 - max 100) COREFO = Colorectal Functional Outcome questionnaire Using a questionnaire Unit = mean score (0-100) | 2 days prior to surgery |
| LARS-scores (low anterior resection syndrome) postoperatively after 1 month, 3 months, 6 months, 1 year and 2 years | 0-20 no LARS 21-29 minor LARS 30-42 major LARS (min 0 - max 42) LARS = low anterior resection syndrome Using a questionnaire Unit = mean score (0-42) | Postoperatively after 1 month, 3 months, 6 months, 1 year and 2 years |
| COREFO-scores (Colorectal Functional Outcome questionnaire) postoperatively after 1 month, 3 months, 6 months, 1 year and 2 years | 27 questions on 5-point Likert scale Higher score = worse bowel function (min 0 - max 100) COREFO = Colorectal Functional Outcome questionnaire Using a questionnaire Unit = mean score (0-100) | Postoperatively after 1 month, 3 months, 6 months, 1 year and 2 years |
| Evolution of quality of defecation process | Visual analogue scale 0-10 0 = worst defecation ever 10 = best defecation ever | 2 years after rectal resection or stoma reversal |
| Incapacity for work | Time (days) between date of start work incapacity and date back to work (if not yet retired) | At diagnose (baseline), 2 days after radiotherapy, 1 week after chemotherapy and 1 month after rectal resection |
| Initiation of treatment for potential LARS (low anterior resection syndrome) during follow-up | Yes/no:
Calculating proportion of patients who received treatment for LARS | Up to 2 years after rectal resection |
| Age |
Age at diagnosis and at surgery |
| Baseline to date of surgery |
| Hospital admission data | Length of stay in days (date of admission for rectal resection until date of dismission) | After rectal resection |
| Medical history | Smoking, diabetes mellitus, abdominal, cardiac, pulmonary (yes/no) | Baseline |
| Anthropometry | Body mass index (kg/m²) | Baseline |
| Tumor location | Distance in cm from recto-anal angle, based on MRI | After restaging prior to surgery |
| Presence of lateral lymph nodes | Presence of lateral lymph nodes (yes/no) | After restaging prior to surgery |
| cTNM | Clinical TNM classification of tumor:
| After restaging prior to surgery |
| Percentage of rectal circumference involved | Percentage of rectal circumference involved: on imaging (CT/MRI), coloscopy or ultrasound-endoscopy | After restaging prior to surgery |
| Circumferential resection margin | Circumferential resection margin (CRM; on MRI; measured from gland; in mm) | After restaging prior to surgery |
| Neoadjuvant therapy | The eventual use of neoadjuvant therapy: radiotherapy (RT), chemotherapy (CT) (yes/no) | From baseline to surgery |
| Radiotherapy dose | Radiotherapy dose (Gy) | From baseline to surgery |
| Chemotherapy type and frequency | Certain type of chemotherapy, used for certain amount of cycles | From baseline to surgery |
| Surgical approach | Surgical approach:
| At surgery |
| Configuration of anastomosis | Configuration of colorectal/coloanal anastomosis:
| At surgery |
| Manual or stapled anastomosis | Manual or stapled anastomosis | At surgery |
| Conversion | Conversion during surgery:
| At surgery |
| Diverting ileostomy | Use of a diverting ileostomy (yes/no) | At surgery |
| Baseline CEA | Baseline CEA: Carcinoembryonic antigen (µg/L) | At baseline |
| Histology type | Histology type of tumor (adenocarcinoma, squamous cell carcinoma, neuro-endocrine tumor etc.) | After surgery |
| Tumor differentiation | Well differentiated Moderately differentiated poorly differentiated | After surgery |
| Tumor perforation | Tumor perforation on histology (yes/no) | After surgery |
| Radical resection | Radical resection: R0, R1, R2 | After surgery |
| pTNM | Pathological TNM classification of tumor
| After surgery |
| Disease free interval | Disease free interval: the period of time between the primary treatment of a malignancy and the first sign of tumor recurrence (in months) | Up to 2 years after rectal resection |
| Type of complication | Type of complication:
| After rectal resection during admission |
| Early complications | Early complications: before 30 days after surgery | Between surgery and 30 days after surgery |
| Late complications | Late complications: more than 30 days after surgery | From 30 days after surgery up to 2 years after surgery |
| Anastomotic leakage | Definition of anastomotic leakage:
(yes/no) | Up to 3 months after surgery |
| Clavien-Dindo classification | Clavien-Dindo classification (grade 0, I, II, IIIa, IIIb, IVa, IVb, V): Grade I: Minor deviation from normal course; no drugs or interventions needed (only supportive care). Grade II: Requires pharmacological treatment (e.g. antibiotics, blood transfusion, TPN). Grade III: Requires surgical, endoscopic, or radiological intervention IIIa: without general anesthesia IIIb: with general anesthesia Grade IV: Life-threatening complication requiring ICU care IVa: single-organ dysfunction IVb: multi-organ dysfunction Grade V: Death | After admission for rectal resection |
| CCI-score | CCI-score: comprehensive complication index (score from 0-100 calculated with online calculator: https://www.cci-calculator.com/cci-calculator) | After admission for rectal resection |
| ID | Term |
|---|---|
| D012004 | Rectal Neoplasms |
| D000094123 | Low Anterior Resection Syndrome |
| ID | Term |
|---|---|
| D015179 | Colorectal Neoplasms |
| D007414 | Intestinal Neoplasms |
| D005770 | Gastrointestinal Neoplasms |
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D004066 | Digestive System Diseases |
| D005767 | Gastrointestinal Diseases |
| D007410 | Intestinal Diseases |
| D012002 | Rectal Diseases |
| D003108 | Colonic Diseases |
| D011183 | Postoperative Complications |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| D011795 | Surveys and Questionnaires |
| ID | Term |
|---|---|
| D003625 | Data Collection |
| D004812 | Epidemiologic Methods |
| D008919 | Investigative Techniques |
| D017531 | Health Care Evaluation Mechanisms |
| D011787 | Quality of Health Care |
| D017530 | Health Care Quality, Access, and Evaluation |
| D011634 | Public Health |
| D004778 | Environment and Public Health |
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