Low Anterior Resection Syndrome After Rectum Resection for Rectal Carcinoma.

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

• Registration Number: NCT05506111
• Lead Sponsor: Paracelsus Medical University

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.

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 Timeline

• Study Start: 2022-07-18
• Study First Submitted: 2022-07-22
• Status Verified: 2022-08
• Study First Submitted QC: 2022-08-16
• Last Update Submitted: 2022-08-17
• Study First Posted: 2022-08-18
• Last Update Posted: 2022-08-19
• Primary Completion: 2024-07-31
• Study Completion: 2024-07-31

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 100

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Detection of Low Anterior Resection Syndrome (LARS) after anterior rectal resection.	12 months after the rectum resection or after the closure of a protective ileostomy or after an Chemoradiation in case of watch and wait	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)

Secondary Outcome Measures

Name	Time	Method
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.	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)

Trial Locations

Locations (3)

Department of Surgery Hospital of St. John of God, Graz; 🇦🇹 Graz, Austria

Department of Surgery Medical University Vienna; 🇦🇹 Wien, Austria

Department of Surgery, Paracelsus Medical University; 🇦🇹 Salzburg, Austria