| Objective: |
The objectives of the study are to:
1. Determine surgical complication rate for each procedure (graded by Clavien-Dindo).
2. Assess impact on secondary outcomes (length of stay, readmission, reintervention, medical complications, time to chemotherapy, quality of life).
3. Determine if the complication rate in IAPE is dependent on surgical technique
4. Determine patient and clinician acceptability to randomization if required. |
| Aim: |
Having established a network of units (UK and Europe) who are also keen to answer this question we have powered a prospective observational cohort study to demonstrate a significant reduction in surgical complication rate (30% to 15%). In conjunction with an on going Swedish randomised trial we hope that the data from this study will provide compelling evidence for UK surgeons to change practice. If the study reveals only a modest difference in complications, we will use the data gathered to design and reapply again for full funding for an RCT with the additional advantage of being able to clearly demonstrate a network of units capable of recruiting the necessary number of patients. The overarching aims of this study are therefore to:
1. Determine the difference in surgical complication rates between HP and IAPE
2. Assess the effect of IAPE technique on intra operative tumour perforation rate.
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| Methods: |
Data will be collected on specific CRF at baseline and 30 post operative days, all data will be completely anonymised and no further data will be collected past 30 days. The easy to use and well validated Clavien-Dindo scale will be use to grade surgical complications, but we will also calculate the Comprehensive Complication Index which integrates all medical and surgical complications and is felt to represent a more accurate estimation of post operative complications (4). Data will be collected at the following time points:
BASELINE INTRAOPERATIVE POST OPERATIVE (30 days) Age Surgical approach (lap, open) Pathological stage Sex Anaesthetic type TME quality BMI Operative time Length of stay Comorbidities Intra operative perforation Readmission ASA score Length of anorectal stump (HP) Surgical complications (Clavien-Dindo scale) Radiological stage Antibiotics Medical complications Distance of tumour from anal verge Method of IAPE (one vs two stage) Comprehensive Classification Index score Preoperative therapy 30 day quality of life Quality of life Patient willingness to randomise Reason for avoiding primary anastomosis Surgeon willingness to randomise Surgeon's reason for op choice
Data Analysis As this is an observation analysis, reporting only the unadjusted difference between HP and IAPE may result in a biased comparison. The primary analysis will therefore be a multivariable analysis adjusting for any confounding factors. To ensure the analysis is in keeping with the sample size calculation, evaluations of the primary outcome will be based on a 90% confidence interval. |
| Reason for International Trial: |
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