| Objective: |
The primary objective of this study is to prospectively evaluate the oncologic, morbidity and functional outcomes for patients with mid- to low rectal cancers following laparotomy, laparoscopy, robotic assisted, or TaTME surgery.
The secondary objectives are to evaluate :
• the long-term co-primary endpoints associating oncologic, morbidity and functional outcomes,
• the oncologic outcomes,
• the functional outcomes,
• the adjustment parameters of surgery,
• the quality of surgery,
• the quality of life
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| Aim: |
Primary endpoint: Efficacy of surgical method defined as a composite outcome including all of the points below
- CRM (≥1mm)
- TME grade III
- The absence of Clavien-Dindo grade III-IV complications within 30 days post op
Secondary endpoints:
- Co primaries endpoints including:
o CRM (≥1mm)
o TME grade III
o The absence of Clavien-Dindo grade III-IV complications within 30 days post op
o Functional outcome 6 months after restoration (LARS 30)
- Oncologic results at 1 year and 2 years
o Overall survival
o Disease free survival (DFS)
o Local pelvic recurrence
o Metastases rate
- Rate of Unplanned Conversions to other surgery
- Operative time (min)
- Complete total mesorectal excision (TME),
- A clear distal resection margin (≥1 mm)
- Length of Stay (LOS, days)
- Quality of life –EORTC QLQ-C30 & QLQ-CR29
- For male subjects dysfunction questionnaires; International Prostatic Symptom Score (IPSS), International Index of Erectile Function (IIEF)
- For female subjects dysfunction questionnaires; Female Sexual Functional Index (FSFI)
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| Methods: |
Observational, prospective, parallel cohorts, international, multi-center study.
At least 1300 subjects will be enrolled in this study (325 per cohort, including 10% of lost to follow-up patients).
All patients during the enrollment period shall be screened and recorded at sites in order to identify any selection bias.
Ethics Committee (EC) approval, with all other country specific approvals, must be obtained for the study prior to study initiation at the site. Subjects must sign an EC approved Informed Consent Form (ICF) prior to enrollment into this study. |
| Reason for International Trial: |
This study is an observational, prospective, parallel cohorts, international, multi-center study.
Sites or surgeons will select cohorts of the study for which they are qualified (learning curve>30 procedures).
Low anterior resection with TME can be performed via several different surgical techniques:
- Laparotomy (open)
- Laparoscopic abdominal approach (Lap)
- Robotic abdominal approach (Robot)
- Transanal approach (TaTME)
The goal of the RESET trial is to evaluate the results of each technique, in case matched high risk surgical patients, against co-primary end points which will include pathologic, oncologic, morbidity and functional results. |
