Low Anterior Resection Syndrome After Rectum Resection for Rectal Carcinoma.

Studien-Informationen Einschlusskriterien Studien-Rationale

Rekrutierend

NCT-Nummer:
NCT05506111

Studienbeginn:
Juli 2022

Letztes Update:
19.08.2022

Wirkstoff:
-

Indikation (Clinical Trials):
Low Anterior Resection Syndrome, Syndrome

Geschlecht:
Alle

Altersgruppe:
Erwachsene (18+)

Phase:
-

Sponsor:
Paracelsus Medical University

Collaborator:
Department of Surgery Hospital of St. John of God, Graz, Medical University of Vienna,

Studienleiter

Stefan Riss, Prof. Dr.
Study Chair
Medical University Wien, Department of Surgery

Felix Aigner, Prof. Dr.
Study Director
Department of Surgery Hospital of St. John of God, Graz

Jaroslav Presl, Dr.
Principal Investigator
Paracelsus Medical University Salzburg, Department of Surgery

Kontakt

Jaroslav Presl, Dr.
Kontakt:
Phone: 00435725555847
E-Mail: j.presl@salk.at» Kontaktdaten anzeigen

Felix Aigner, Prof. Dr.
Kontakt:
E-Mail: Felix.Aigner@bbgraz.at» Kontaktdaten anzeigen

Studienlocations
(3 von 3)

Department of Surgery Hospital of St. John of God, Graz
8020 Graz
AustriaRekrutierend» Google-Maps
Ansprechpartner:
Felix Aigner, Prof. Dr.» Ansprechpartner anzeigen

Department of Surgery, Paracelsus Medical University
5020 Salzburg
AustriaRekrutierend» Google-Maps
Ansprechpartner:
Jaroslav Presl, Dr.
Phone: 00435725555847
E-Mail: j.presl@salk.at» Ansprechpartner anzeigen

Department of Surgery Medical University Vienna
1090 Wien
AustriaRekrutierend» Google-Maps
Ansprechpartner:
Stefan Riss, Prof. Dr.» Ansprechpartner anzeigen

Studien-Informationen

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)

Ein-/Ausschlusskriterien

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),...)

Studien-Rationale

Primary outcome:

1. Detection of Low Anterior Resection Syndrome (LARS) after anterior rectal resection. (Time Frame - 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)

2. Detection of Low Anterior Resection Syndrome (LARS) after anterior rectal resection. (Time Frame - 6 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)

3. Detection of Low Anterior Resection Syndrome (LARS) after anterior rectal resection. (Time Frame - 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:

1. 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. (Time Frame - 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)

Quelle: ClinicalTrials.gov

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