Rectal Neoplasm
Conditions
Keywords
Rectal cancer, Robotic surgery, Laparoscopic surgery
Brief summary
After introducing minimally invasive surgery, robotic surgery has been increasingly used in colorectal cancer. However, there is a few prospective study for robotic surgery. The aim of this trial is to evaluate the effectiveness and safety of robotic surgery in mid or low rectal cancer.
Detailed description
This study was designed as randomized phase II trial (laparoscopic versus robotic). The primary end point is quality of mesorectal excision.
Interventions
PROCEDURERobotic surgery
Robotic assisted rectal resection
PROCEDURELaparoscopic surgery
Laparoscopic assisted rectal resection
Sponsors
National Cancer Center, Korea
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
* mid or low rectal cancer (within 9cm from anal verge) * pathologically proven as adenocarcinoma * written informed consent * no severe functional disability in lung and heart
Exclusion criteria
* invading adjacent organ * distant metastasis (lung, liver, brain, bone, distant lymph nodes etc.) * lateral pelvic lymph node metastasis * Have severe concomitant disease that might limit compliance or completion of the protocol. * Have any other malignancy that might impact 5-year survival or might be potentially confused with rectal cancer. * If female, be pregnant or breast feeding. * Hereditary colorectal cancer (HNPCC, FAP etc) * emergency operation
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Quality of mesorectal excision | 7days after surgery (Pathologic report) | Evaluating the quality of mesorectal excision in rectal specimen according to the criteria suggested by Nagtegaal ID, et al. (J Clin Oncol. 2002;20:1729-34) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Short-term postoperative outcome | Within postoperative 30 days | — |
| Sexual and urinary function, Quality of life, Anorectal function | Baseline, postop 3 weeks, 3months, 12 months, 24 months, 36 months | IIEF, FSFI, IPSS, EORTC C30, CR38, FISI, MSKCC bowel fuction tool, Manometry |
| Long-term outcome | Postoperative 36 months | 3 year disese-free survival |
Countries
South Korea
Contacts
Primary ContactJae Hwan Oh, Dr.
Backup ContactJi Won Park, Dr.
Outcome results
None listed