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

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

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

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

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

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

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

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

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

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)

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)

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)

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)

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)

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)

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)

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)

Visual analogue scale 0-10 0 = worst defecation ever 10 = best defecation ever

Time (days) between date of start work incapacity and date back to work (if not yet retired)

Yes/no:

• Dietary measures
• Medication (probiotics, antidiarrheals, ...)
• Pelvic floor physiotherapy
• Transanal irrigation, rectal irrigation, enema
• Neuromodulation (neurostimulator)
• Other

Calculating proportion of patients who received treatment for LARS

Male, female, other

Year of birth

Age at diagnosis and at surgery

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

Smoking, diabetes mellitus, abdominal, cardiac, pulmonary (yes/no)

Body mass index (kg/m²)

Distance in cm from recto-anal angle, based on MRI

Presence of lateral lymph nodes (yes/no)

Clinical TNM classification of tumor:

• T: tumor size
• N: nodal involvement
• M: metastasis

Percentage of rectal circumference involved: on imaging (CT/MRI), coloscopy or ultrasound-endoscopy

Circumferential resection margin (CRM; on MRI; measured from gland; in mm)

The eventual use of neoadjuvant therapy: radiotherapy (RT), chemotherapy (CT) (yes/no)

Radiotherapy dose (Gy)

Certain type of chemotherapy, used for certain amount of cycles

Surgical approach:

• Open
• Laparoscopy
• Robot
• Transanal (TaTME)

Configuration of colorectal/coloanal anastomosis:

• End-to-End
• Side-to-End
• End-to-Side
• Side-to-Side

Manual or stapled anastomosis

Conversion during surgery:

• Robot to laparoscopy (yes/no)
• Laparoscopy to open (yes/no)

Use of a diverting ileostomy (yes/no)

Baseline CEA: Carcinoembryonic antigen (µg/L)

Histology type of tumor (adenocarcinoma, squamous cell carcinoma, neuro-endocrine tumor etc.)

Well differentiated Moderately differentiated poorly differentiated

Tumor perforation on histology (yes/no)

Radical resection: R0, R1, R2

Pathological TNM classification of tumor

• T: tumor size
• N: nodal involvement
• M: metastasis

Disease free interval: the period of time between the primary treatment of a malignancy and the first sign of tumor recurrence (in months)

Type of complication:

• Urinary tract infection
• Pulmonary complications
• Surgical site infection
• Intra-abdominal collections/abscess
• Eventration/evisceration
• Ileus
• Small bowel obstruction
• Anastomotic leakage
• Deep venous thrombosis
• Postoperative bleeding
• Acute renal failure
• High output ileostomy
• Other stoma related complications
• Other (yes/no)

Early complications: before 30 days after surgery

Late complications: more than 30 days after surgery

Definition of anastomotic leakage:

• Clinically manifest insufficiency of the anastomosis leading to a clinical state requiring treatment, diagnosed in accordance with surgical practice guidelines by a senior surgeon (no additional or systematic routine iconography nor colonoscopy)
• Radiological evidence of anastomotic leakage if the patient is clinically symptomatic. Fistulas communicating with the anastomosis on CT scan are classified as AL together with presacral abscesses if extravasation of the colonic contrast is visible on radiological imaging (ref. SAFE 2019 Clinical Investigation Plan)

(yes/no)

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

CCI-score: comprehensive complication index (score from 0-100 calculated with online calculator: https://www.cci-calculator.com/cci-calculator)