Clinical trial NCT05506111: Low Anterior Resection Syndrome After Rectum Resection for Rectal Carcinoma.
Official title: Erfassung Des Low Anterior Resection Syndroms Nach Rektumresektion Bei Patienten Mit Einem Rektumkarzinom - Eine österreichweite Multi-center Studie
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Low Anterior Resection Syndrome
Quality of Life
Incontinence
Lead sponsor: Paracelsus Medical University
Sponsor class: OTHER
Collaborators: name: Department of Surgery Hospital of St. John of God, Graz
name: Medical University of Vienna
First posted: 2022-08-18
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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.

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)

Eligibility criteria: 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),...)

Primary outcomes:
measure: Detection of Low Anterior Resection Syndrome (LARS) after anterior rectal resection.
timeFrame: 3 months after the rectum resection or after the closure of a protective ileostomy or after an Chemoradiation in case of watch and wait
measure: Detection of Low Anterior Resection Syndrome (LARS) after anterior rectal resection.
timeFrame: 6 months after the rectum resection or after the closure of a protective ileostomy or after an Chemoradiation in case of watch and wait
measure: Detection of Low Anterior Resection Syndrome (LARS) after anterior rectal resection.
timeFrame: 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:
measure: 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.
timeFrame: At the time of the diagnosis (baseline) and 6 to 8 weeks after an Chemo-Radiation, directly before the surgery respectively.
Other outcomes:
measure: Recording the risk factors for the occurrence of LARS.
timeFrame: baseline
measure: Recording the risk factors for the occurrence of LARS.
timeFrame: up to 4 weeks after the intervention/surgery or at the time of discharge from the hospital (if hospital stay longer than 4 weeks)
Locations:
city: Graz
country: Austria
facility: Department of Surgery Hospital of St. John of God, Graz
city: Salzburg
country: Austria
facility: Department of Surgery, Paracelsus Medical University
city: Wien
country: Austria
facility: Department of Surgery Medical University Vienna
Study officials:
affiliation: Medical University Wien, Department of Surgery
name: Stefan Riss, Prof. Dr.
role: STUDY_CHAIR
affiliation: Department of Surgery Hospital of St. John of God, Graz
name: Felix Aigner, Prof. Dr.
role: STUDY_DIRECTOR
affiliation: Paracelsus Medical University Salzburg, Department of Surgery
name: Jaroslav Presl, Dr.
role: PRINCIPAL_INVESTIGATOR
References: