Low Anterior Resection Syndrome After Rectum Resection for Rectal Carcinoma.

Quality of Life Clinical Trial

— LARS-Austria  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05506111
• Other study ID #: 1110/2021
• Status: Recruiting
• Start date: July 18, 2022
• Est. completion date: July 31, 2024

Study information

• Verified date: August 2022
• Source: Paracelsus Medical University
• Contact: Jaroslav Presl, Dr.
• Phone: 00435725555847
• Email: j.presl[@]salk.at
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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.

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)

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: July 31, 2024
• Est. primary completion date: July 31, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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),...)

Related Conditions & MeSH terms

• Incontinence
• Low Anterior Resection Syndrome
• Quality of Life
• Syndrome

Locations

Country	Name	City	State
Austria	Department of Surgery Hospital of St. John of God, Graz	Graz
Austria	Department of Surgery, Paracelsus Medical University	Salzburg
Austria	Department of Surgery Medical University Vienna	Wien

Sponsors (3)

Lead Sponsor	Collaborator
Paracelsus Medical University	Department of Surgery Hospital of St. John of God, Graz, Medical University of Vienna

Country where clinical trial is conducted

Austria, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Recording the risk factors for the occurrence of LARS.	Assessing the potential risk factors like patient age, tumour high, patient BMI, UICC Stage (Union Internationale Contre le Cancer).	baseline
Other	Recording the risk factors for the occurrence of LARS.	Assessing the potential risk factors like art of the operation, postoperative complications, protective stoma, chemo-radiation.	up to 4 weeks after the intervention/surgery or at the time of discharge from the hospital (if hospital stay longer than 4 weeks)
Primary	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
Primary	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
Primary	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	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.	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)	At the time of the diagnosis (baseline) and 6 to 8 weeks after an Chemo-Radiation, directly before the surgery respectively.