Low Anterior Resection Syndrome After Rectum Resection for Rectal Carcinoma. (LARS-Austria)

Erfassung Des Low Anterior Resection Syndroms Nach Rektumresektion Bei Patienten Mit Einem Rektumkarzinom - Eine österreichweite Multi-center Studie

The ACO-ASSO (Austrian Society of Surgical Oncology) colorectal group and Austrian Working Group for Coloproctology present the LARS Austria study. It is a prospective, multicenter observational study. The primary objective of this study is to collect information about LARS (LARS score) and QoL (EORTC -CR29) in patients with non-metastatic rectal cancer who received therapy. As a secondary objective, the impact of radiotherapy on the occurrence of LARS will be investigated.

Study Overview

• Status: Recruiting
• Conditions: Quality of Life; Low Anterior Resection Syndrome; Incontinence

Detailed Description

All consecutive patients with biopsy verified rectal cancer (≤16cm from anocutaneous line) can be included in the study. For the study, tumors whose aboral margin, when measured with a rigid rectoscope, is 16 cm or less from the anocutaneous line will be included. Thus, only histologically verified tumors of the lower (<6 cm), middle (6<12 cm) and upper (12-16cm) rectal thirds are included.

Patients will be included after the indication for further therapy has been established in the tumor board according to guideline criteria and after signing the participation consent. The collection of study relevant data will be performed according to the following scheme:

Group 1 = patients without neoadjuvant radiochemotherapy (RCHT). Collection of data and questionnaires before surgery and 3, 6, and 12 months after index surgery (if no protective stoma).

OR Collection of data and questionnaires before surgery and 3, 6, or 12 months after stoma re-operation (if protective stoma).

Group 2 = patients with neoadjuvant RCHT/ definitive RCHT=watch and wait. Collection of data and questionnaires before RCHT and before surgery or after RCHT and 3, 6, or 12 months after index surgery (if no protective stoma).

OR Collection of data and questionnaires before RCHT and before operation=surgery(OP) or after RCHT and 3, 6 or 12 months after stoma closure (if protective stoma) OR Collection of data and questionnaires before RCHT and 3, 6 and 12 months after RCHT (if no surgery)

• Study Type: Observational
• Enrollment (Anticipated): 100

Contacts and Locations

• Study Contact: Name: Jaroslav Presl, Dr.; Phone Number: 00435725555847; Email: j.presl@salk.at
• Study Contact Backup: Name: Felix Aigner, Prof. Dr.; Email: Felix.Aigner@bbgraz.at

Study Locations

• Austria
  • Graz, Austria, 8020
    • Recruiting
    • Department of Surgery Hospital of St. John of God, Graz
    • Contact: Felix Aigner, Prof. Dr.
  • Salzburg, Austria, 5020
    • Recruiting
    • Department of Surgery, Paracelsus Medical University
    • Contact: Jaroslav Presl, Dr.; Phone Number: 00435725555847; Email: j.presl@salk.at
  • Wien, Austria, 1090
    • Recruiting
    • Department of Surgery Medical University Vienna
    • Contact: Stefan Riss, Prof. Dr.

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

All consecutive patients with a bioptically verified rectal carcinoma ≤16 cm from anocutaneous line) can be included in the study. Patients will be included only after the indication for further therapy has been established in the tumor board according to guideline criteria and after signing the informed consent form.

Description

Inclusion Criteria:

• Age: 18 to 99 years
• Patients with biopsy-verified rectal cancer.
• Patients scheduled for elective sphincter-preserving rectal surgery
• Patients scheduled for neoadjuvant RCTx (Chemo-radiation) (concept: short course radiation, conv.

fractionated RCTx, total neoadjuvant therapy(TNT))

• Signed consent (ICF)

Exclusion Criteria:

• Patients younger than 18 years
• Patients without signed informed consent
• Metastatic carcinoma
• terminal colostomy ( APR (abdominoperineal resection),...)

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Detection of Low Anterior Resection Syndrome (LARS) after anterior rectal resection.	Occurrence of Low Anterior Resection Syndrome (LARS) will be measured with an LARS Score. The score ranges from 0 to 42 is divides into no LARS (0 to 20 points), minor LARS (21 to 29 points), and major LARS (30 to 42 points)	3 months after the rectum resection or after the closure of a protective ileostomy or after an Chemoradiation in case of watch and wait
Detection of Low Anterior Resection Syndrome (LARS) after anterior rectal resection.	Occurrence of Low Anterior Resection Syndrome (LARS) will be measured with an LARS Score. The score ranges from 0 to 42 is divides into no LARS (0 to 20 points), minor LARS (21 to 29 points), and major LARS (30 to 42 points)	6 months after the rectum resection or after the closure of a protective ileostomy or after an Chemoradiation in case of watch and wait
Detection of Low Anterior Resection Syndrome (LARS) after anterior rectal resection.	Occurrence of Low Anterior Resection Syndrome (LARS) will be measured with an LARS Score. The score ranges from 0 to 42 is divides into no LARS (0 to 20 points), minor LARS (21 to 29 points), and major LARS (30 to 42 points)	12 months after the rectum resection or after the closure of a protective ileostomy or after an Chemoradiation in case of watch and wait

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Assessing the difference in LARS Score between the time of the diagnoses (baseline)and after the chemoradiation to identify the impact of the neoadjuvant Chemo-Radiation on LARS.	Occurrence of Low Anterior Resection Syndrome (LARS) will be measured with an LARS Score. The score ranges from 0 to 42 is divides into no LARS (0 to 20 points), minor LARS (21 to 29 points), and major LARS (30 to 42 points)	At the time of the diagnosis (baseline) and 6 to 8 weeks after an Chemo-Radiation, directly before the surgery respectively.

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Recording the risk factors for the occurrence of LARS.	Assessing the potential risk factors like patient age, tumour high, patient BMI, UICC Stage (Union Internationale Contre le Cancer).	baseline
Recording the risk factors for the occurrence of LARS.	Assessing the potential risk factors like art of the operation, postoperative complications, protective stoma, chemo-radiation.	up to 4 weeks after the intervention/surgery or at the time of discharge from the hospital (if hospital stay longer than 4 weeks)

Collaborators and Investigators

• Sponsor: Paracelsus Medical University
• Collaborators: Medical University of Vienna; Department of Surgery Hospital of St. John of God, Graz
• Investigators: Study Chair: Stefan Riss, Prof. Dr., Medical University Wien, Department of Surgery; Study Director: Felix Aigner, Prof. Dr., Department of Surgery Hospital of St. John of God, Graz; Principal Investigator: Jaroslav Presl, Dr., Paracelsus Medical University Salzburg, Department of Surgery

Study record dates

Study Major Dates

• Study Start (Actual): July 18, 2022
• Primary Completion (Anticipated): July 31, 2024
• Study Completion (Anticipated): July 31, 2024

Study Registration Dates

• First Submitted: July 22, 2022
• First Submitted That Met QC Criteria: August 16, 2022
• First Posted (Actual): August 18, 2022

Study Record Updates

• Last Update Posted (Actual): August 19, 2022
• Last Update Submitted That Met QC Criteria: August 17, 2022
• Last Verified: August 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Disease; Syndrome
• Other Study ID Numbers: 1110/2021

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No