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Comparing international data between keyhole and robotic rectal cancer surgery

Not Applicable
Conditions
Colorectal cancer
Cancer
Registration Number
ISRCTN75281193
Lead Sponsor
Portsmouth Hospitals NHS Trust
Brief Summary

Not available

Detailed Description

Not available

Recruitment & Eligibility

Status
Ongoing
Sex
All
Target Recruitment
3000
Inclusion Criteria

1. All patients who underwent a laparoscopic or robotic proctectomy with partial or complete TME after 2015;
2. Aged 18 years or above;
3. Rectal cancer tumour located within 15 cm from the anal verge or 20 cm from the anorectal junction.

Exclusion Criteria

1. Patients that underwent an APER or Hartmann’s procedure
2. Patients that underwent robotic TME surgery as part of a more complex procedure, for example a peritonectomy, or a synchronous colonic or hepatic resection.
3. Patients that underwent palliative resection
4. Patients that underwent emergency resection

Study & Design

Study Type
Observational
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
The primary outcome variables will be measured using data held in pre-existing databases at each of the participating sites from rectal cancer patients who underwent robotic total mesorectal excision (TME) surgery at one timepoint:<br>1. Length of stay in days after surgery<br>2. Operative time in minutes<br>3. Blood loss in millilitres
Secondary Outcome Measures
NameTimeMethod
The secondary outcome variables will be measured using data held in pre-existing databases at each of the participating sites from rectal cancer patients who underwent robotic total mesorectal excision (TME) surgery at one timepoint:<br>1. Intraoperative and postoperative complications recorded as timepoint, type of complication, and Clavien-Dindo classification grading of complication<br>2. Reinterventions and readmissions after surgery recorded as yes/no and timepoint<br>3. Pathological outcomes recorded as the number of positive lymph nodes, differentiation grading, quality of the specimen, and positivity of circumferential resection margins<br>4. Stoma formation as yes/no and type, as well as reversal of stoma and timepoint of reversal<br>5. Local recurrence of disease as yes/no and timepoint<br>6. Distant recurrence of disease as yes/no, timepoint, and location of recurrence<br>7. Disease-free survival as yes/no and timepoint<br>8. Overall survival as yes/no and timepoint
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