Long-term Cohort Study of Mesorectal Excision for Rectal Cancer

Studien-Informationen Einschlusskriterien Studien-Rationale Geprüfte Regime

Rekrutierend

NCT-Nummer:
NCT05112016

Studienbeginn:
Januar 2007

Letztes Update:
08.11.2021

Wirkstoff:
-

Indikation (Clinical Trials):
Rectal Neoplasms

Geschlecht:
Alle

Altersgruppe:
Erwachsene (18+)

Phase:
-

Sponsor:
Kantonsspital Winterthur KSW

Collaborator:
-

Studienleiter

Michel Adamina, Prof/MD/MSc
Principal Investigator
Kantonsspital Winterthur KSW

Kontakt

Michel Adamina, Prof/MD/MSc
Kontakt:
Phone: +41522663376
E-Mail: michel.adamina@ksw.ch» Kontaktdaten anzeigen

Kantonsspital Winterthur

Studienlocations
(1 von 1)

Kantonsspital Winterthur
8401 Winterthur
SwitzerlandRekrutierend» Google-Maps
Ansprechpartner:
Michel Adamina, Prof/MD/MSc
Phone: +41522663634
E-Mail: michel.adamina@ksw.ch» Ansprechpartner anzeigen

Studien-Informationen

Detailed Description:

Outcomes of mesorectal excision patients will be analysed. Medical records will be reviewed

and perioperative outcomes retrieved, incl. long-term oncological and functional/quality of

life data. A retrospective cohort over 10 years (2007-2016) will serve as a control to a

prospective cohort over 10 further years (2017-2026) as to investigate trends in

perioperative and oncological outcomes (min. follow-up of 5 years + adequate cohort size).

Prospective data on bowel function, urogenital function and quality of life will measured at

time of diagnosis and further. Variations in neoadjuvant/adjuvant treatment and surgical

approaches will be assessed for their effect on the outcomes of interest.

Ein-/Ausschlusskriterien

Inclusion Criteria:

- Men and Women >18 years

- Patients with rectal cancer

- Underwent mesorectal excision

- Agreed to fill in a validated questionnaires before surgery and after stoma reversal

- Informed consent

Exclusion Criteria:

- Age < 18

- No informed consent (no general consent, no consent to use personal data for research

purpose)

Studien-Rationale

Primary outcome:

1. Perioperative mortality (Time Frame - 90 days):
Reporting perioperative mortality with Clavien-Dindo & Comprehensive Complications Index

2. Age (Time Frame - 10 years):
Age (years)

3. Body mass index (Time Frame - 10 years):
BM (kg/m2)

4. Gender (Time Frame - 10 years):
Sex (male, female)

5. ASA score (Time Frame - 10 years):
American Society of Anesthesiologists score (I to V)

6. Date of surgery (Time Frame - day of surgery):
date of surgery (day-month-year)

7. Tumor localisation (Time Frame - 10 years):
Description of tumor localisation

8. Comorbidities (Time Frame - day of surgery):
Charlson index

9. Perioperative complications (Time Frame - 90 days):
Reporting and grading of postoperative surgical complications (according to Dindo-Clavien classification and/or comprehensive complications index)

10. Histological results (Time Frame - 30 days):
Histological staging and grading of the specimen by a pathologist

11. Quality of life, including functional and symptom scales, incontinence scores, sexual function (Time Frame - 10 years):
taTME survey (validated english, german, french versions); from 0 (worst) to 100 (best)

Secondary outcome:

1. Perioperative treatment (Time Frame - 10 years):
Chemoradiation before or after surgery, other treatments necessary

2. Surgery time (Time Frame - day of surgery):
Duration of surgery in minutes

3. Length of hospital stay (Time Frame - 90 days):
Length of hospital stay in days

4. Readmission rate (Time Frame - 90 days):
Number of patients readmitted within 90 days of index surgery divided by the total number of patients operated

5. Costs (Time Frame - 10 years):
At the level of individual patient Cost in terms of hospital charges and expenses in Swiss Francs. Actual costs and micro-costing

Geprüfte Regime

Total mesorectal excision for rectal cancer (TME)

Quelle: ClinicalTrials.gov

Sie können folgenden Inhalt einem Kollegen empfehlen:

"Long-term Cohort Study of Mesorectal Excision for Rectal Cancer"

Bitte tragen Sie auch die Absenderdaten vollständig ein, damit Sie der Empfänger erkennen kann.

Die mit (*) gekennzeichneten Angaben müssen eingetragen werden!