Low Anterior Resection Syndrome After Rectum Resection for Rectal Carcinoma.

NCT05506111 | Unknown

• 1 other identifier: 1110/2021
• Study Type: observational
• Target: 100
• Locations: 1 country
• Sites: 3

Brief Summary

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.

Conditions

Low Anterior Resection Syndrome; Quality of Life; Incontinence

Outcome Measures

Primary Outcomes (3)

• 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 Outcomes (1)

• 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.

  At the time of the diagnosis (baseline) and 6 to 8 weeks after an Chemo-Radiation, directly before the surgery respectively.

Other Outcomes (2)

• Recording the risk factors for the occurrence of LARS.

  baseline

• Recording the risk factors for the occurrence of LARS.

  up to 4 weeks after the intervention/surgery or at the time of discharge from the hospital (if hospital stay longer than 4 weeks)

Eligibility Criteria

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

You may qualify if:

• 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)

You may not qualify if:

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

Sponsors & Collaborators

• Paracelsus Medical University: lead
• Department of Surgery Hospital of St. John of God, Graz: collaborator
• Medical University of Vienna: collaborator

Study Sites (3)

Department of Surgery Hospital of St. John of God, Graz

Graz, 8020, Austria

RECRUITING

Department of Surgery, Paracelsus Medical University

Salzburg, 5020, Austria

RECRUITING

Department of Surgery Medical University Vienna

Vienna, 1090, Austria

RECRUITING

MeSH Terms

Conditions

Low Anterior Resection Syndrome

Condition Hierarchy (Ancestors)

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

Study Officials

• Stefan Riss, Prof. Dr.

  Medical University Wien, Department of Surgery

  STUDY CHAIR

• Felix Aigner, Prof. Dr.

  Department of Surgery Hospital of St. John of God, Graz

  STUDY DIRECTOR

• Jaroslav Presl, Dr.

  Paracelsus Medical University Salzburg, Department of Surgery

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Jaroslav Presl, Dr.

CONTACT

00435725555847; j.presl@salk.at

Felix Aigner, Prof. Dr.

CONTACT

Felix.Aigner@bbgraz.at

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 12 Months
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: July 22, 2022
• First Posted: August 18, 2022
• Study Start: July 18, 2022
• Primary Completion: July 31, 2024
• Study Completion: July 31, 2024
• Last Updated: August 19, 2022

Record last verified: 2022-08

Locations

AU (3)