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

Paracelsus Medical University (PMU)

Status: Enrolling

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

Study type: Observational

Funder types: Other

Identifiers

NCT05506111

1110/2021

Details and patient eligibility

About

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.

Full 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)

Enrollment: 100 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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),...)