Relook Laparoscopy for Peritoneal Surface Disease (ReLaPSeD) TrialA prospective randomised controlled trial comparing relook laparoscopy vs. standard follow-up for early detection and treatment of patients at high risk for peritoneal metastases after resection of colorectal cancer
Not Applicable
Recruiting
- Conditions
- Colorectal cancer with high risk features for peritoneal metastasesCancer - Bowel - Back passage (rectum) or large bowel (colon)Surgery - Other surgery
- Registration Number
- ACTRN12618000372280
- Lead Sponsor
- Surgical Outcome Research Centre
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- All
- Target Recruitment
- 194
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
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method To report and compare the 3-year overall survival in patients managed with relook laparoscopy vs. standard follow-up following curative resection for high risk colorectal cancer[ 3 years post-randomisation]
- Secondary Outcome Measures
Name Time Method