Long-term Cohort Study of Mesorectal Excision for Rectal Cancer

Study Overview
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Brief Summary
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The aim of this cohort study is to record, evaluate and compare the surgical, oncological as well as the functional outcome and Quality of life after mesorectal excision for rectal cancer

Detailed Description
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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.

Official Title
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Long-term Cohort Study of Mesorectal Excision for Rectal Cancer

Conditions
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Rectum, Cancer

Intervention / Treatment
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* Procedure: Total mesorectal excision for rectal cancer


Participation Criteria
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Eligibility Criteria
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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)

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| TME for rectal cancer<br>Patients with rectal cancer treated by TME (laparoscopic TME, transanal TME, robotic TME, open TME) | Procedure: Total mesorectal excision for rectal cancer<br> <br> * Other names: TME;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Perioperative mortality | Reporting perioperative mortality with Clavien-Dindo & Comprehensive Complications Index | 90 days | 
| Age | Age (years) | 10 years | 
| Body mass index | BM (kg/m2) | 10 years | 
| Gender | Sex (male, female) | 10 years | 
| ASA score | American Society of Anesthesiologists score (I to V) | 10 years | 
| Date of surgery | date of surgery (day-month-year) | day of surgery | 
| Tumor localisation | Description of tumor localisation | 10 years | 
| Comorbidities | Charlson index | day of surgery | 
| Perioperative complications | Reporting and grading of postoperative surgical complications (according to Dindo-Clavien classification and/or comprehensive complications index) | 90 days | 
| Histological results | Histological staging and grading of the specimen by a pathologist | 30 days | 
| Quality of life, including functional and symptom scales, incontinence scores, sexual function | taTME survey (validated english, german, french versions); from 0 (worst) to 100 (best) | 10 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Perioperative treatment | Chemoradiation before or after surgery, other treatments necessary | 10 years | 
| Surgery time | Duration of surgery in minutes | day of surgery | 
| Length of hospital stay | Length of hospital stay in days | 90 days | 
| Readmission rate | Number of patients readmitted within 90 days of index surgery divided by the total number of patients operated | 90 days | 
| Costs | At the level of individual patient Cost in terms of hospital charges and expenses in Swiss Francs. Actual costs and micro-costing | 10 years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Robotic TME, TME (total mesorectal excision), Transanal TME, Laparoscopic TME, Open TME, Quality of life