ACTRN12618000372280
Recruiting
未知
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
Surgical Outcome Research Centre0 sites194 target enrollmentStarted: March 12, 2018Last updated:
Overview
- Phase
- 未知
- Status
- Recruiting
- Sponsor
- Surgical Outcome Research Centre
- Enrollment
- 194
Overview
Brief Summary
No summary available.
Study Design
- Study Type
- Interventional
- Allocation
- Randomised controlled trial
- Primary Purpose
- Treatment
- Masking
- Open (masking not used)
Eligibility Criteria
- Ages
- 18 Years to 80 Years (—)
- Sex
- All
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
Investigators
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