Colorectal surgery for colorectal cancer Surgery
Conditions
Interventions
The total study duration will be approximately 3 years. Study follow-up will be 12 months after date of surgery. Patients will have their blood drawn before surgery, and on days 1, 3 and 5 after surge
Sponsors
Portsmouth Hospitals NHS Trust
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Age 18 years or above. 2. Diagnosed with rectal cancer, up to 15cm from the anal verge. 3. Local MDT recommends rectal cancer surgery (i.e. (high) anterior resection, partial TME, complete TME) 4. Patient assessed as fit for surgery (ASA I-III). 5. Patient willing and able to give informed consent for participation in the study. 6. Elective surgery.
Exclusion criteria
Exclusion criteria: 1. Patient planned for Abdominoperineal Excision of Rectum (APER) or Hartmann’s procedure 2. Patients with confirmed or suspected metastatic disease. 3. Pregnant or breastfeeding patients. 4. Previous pelvic radiation for other cancers. 5. Inflammatory bowel disease (IBD). 6. Other known auto-immune disease which might influence the immune response (such as advanced liver disease, human immunodeficiency virus infection, Hepatitis B or C virus). 7. Use of anti-inflammatory medication (i.e. corticosteroids, anti-inflammatory drugs, immune modulating drugs, chronic use of antibiotics (the use of NSAIDS and steroid asthma inhalers will not be considered an exclusion criteria). 8. High pre-operative C-reactive protein (CRP) levels (>20).
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To assess the stress response after rectal cancer surgery and the assessment of sexual, urological and bowel function after rectal cancer surgery.This will be based on 2 primary outcome measurements. 1. Measurement of the stress response by taking blood samples at baseline and on postoperative days 1, 3 and 5: 1.1. White cell count 1.2. CRP 1.3. NLR (neutrophil lymphocyte ratio) 1.4. IL-6 1.5. IL-10 1.6. TNFa 1.7. MPO (neutrophil myeloperoxidase) 2. Functional assessment of sexual, urological and bowel function with the use of validated questionnaires at 12 months: 2.1. International Prostatic Symptoms Score (IPSS) (male) 2.2. International Index of Erectile Function (IIEF) (male) 2.3. Female Sexual Function Index (FSFI) (female) 2.4. Kings Health Questionnaire (KH) (female) 2.5. LARS-score (male/female) 2.6. Vaizey score (male/female) | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Quality of life assessment using validated questionnaires (EORTC QLQ-C30/ CR29 and EQ-5D) at baseline, after 6 months and after 12 months. 2. Surgical outcomes, such as operative time, blood loss, stoma application, conversion, and intra-operative complications 3. Patient-related outcomes at 12 months measured using patient records: 3.1. Length of hospital stay 3.2. Opioid requirements and compliance with ERP 3.3. Worst vital signs post op 3.4. Worst pain scores 3.5. Time to flatus (in days) and return of bowel function 3.6. Early morbidity (up to 30-day postoperative complications, Clavien-Dindo Classification) 3.7. Early mortality 3.8. Adverse events. 4. Optional: assessment of anorectal physiology after laparoscopic or robotic surgery in rectal cancer patients by using an anorectal manometry at baseline and after 1 year(Assessment will be done in the outpatient clinic when patients come for their standard care preoperative and 12-month follow-up visit. The manometry will be performed by the clinical team using departmental equipment.) | — |
Countries
United Kingdom
Outcome results
None listed