None listed
Conditions
Brief summary
This study has been designed to compare relook laparoscopy versus standard follow up for early detection and treatment of patients at high risk for metastases after resection of colorectal cancer. Who is it for? You may be eligible for this study if you are aged between 18 and 80 years, have been diagnosed with primary colorectal cancer for which you have undergone colorectal resection, and are at high risk of the cancer spreading within the abdomen (peritoneal metastases). Study details Participants will be randomly allocated (by chance) to undergo either a relook laparoscopy 9-12 months after initial colorectal cancer surgery in addition to standard follow-up or continue with standard follow-up only. Diagnostic laparoscopy refers to examination of the abdominal cavity through minimally-invasive ("key-hole") surgery. Standard follow up tests include regular blood tests for levels of tumour markers (every three months) and regular CT scans (yearly). Participants will then be followed up over three years to assess disease status (i.e. remission or relapse) and to complete a series of questionnaires to determine quality of life. It is hoped that this research will help determine whether a relook laparoscopy is a valid and effective way of increasing survival rates in patients with high risk colorectal cancer.
Interventions
Diagnostic laparoscopy refers to examination of the abdominal cavity through minimally-invasive ("key-hole") surgery. It takes approximately 45 - 60 minutes and will be performed by a specialist colorectal surgeon.
Patients randomised to the intervention group will undergo relook diagnostic laparoscopy at 9- 12 months post surgery (in addition to standard follow up tests, including clinical review, tumour markers and regular CT scans).
Sponsors
Surgical Outcome Research Centre
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Open (masking not used)
Eligibility
Sex/Gender
All
Age
18 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
Resected colorectal adenocarcinoma (confirmed on histopathology) with complete oncological excision (i.e. clear resection margins), AND, one or more of the following high-risk features: i. Synchronous peritoneal or ovarian metastases that were resected completely at time of surgery ii. Perforated tumour (including iatrogenic perforation) iii. T4 tumour iv. Mucinous T3 tumour
Exclusion criteria
i. Metastatic disease on preoperative staging ii. Recurrent disease on staging after adjuvant chemotherapy iii. Age < 18 or > 80 iv. ASA >3, ECOG >2 v. Tumour histology not colorectal adenocarcinoma vi. Major uncontrolled medical comorbidity vii. Medical conditions causing inability to give informed consent or comply with the study protocol
Outcome results
None listed