Low Anterior Resection Syndrome After Rectum Resection for Rectal Carcinoma.

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

Status

UNKNOWN

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT05506111

Acronym

LARS-Austria

Enrollment

100

Registered

2022-08-18

Start date

2022-07-18

Completion date

2024-07-31

Last updated

2022-08-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Incontinence, Low Anterior Resection Syndrome, Quality of Life

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)

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

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),...)

Design outcomes

Primary

Measure	Time frame	Description
Detection of Low Anterior Resection Syndrome (LARS) after anterior rectal resection.	3 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

Measure	Time frame	Description
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)

Other

Measure	Time frame	Description
Recording the risk factors for the occurrence of LARS.	baseline	Assessing the potential risk factors like patient age, tumour high, patient BMI, UICC Stage (Union Internationale Contre le Cancer).

Countries

Austria

Contacts

Primary ContactJaroslav Presl, Dr.

j.presl@salk.at00435725555847

Backup ContactFelix Aigner, Prof. Dr.

Felix.Aigner@bbgraz.at

Outcome results