Lower Rectal Cancer and Proctal Cancer
Conditions
Interventions
Sponsors
Eligibility
Inclusion criteria
Inclusion criteria: 1) The male patients with the lower rectal cancer and proctal cancer, which are adapted for TaTME and TpTME: which are located within about 6cm from the anal verge. 2) The male patients with the lower rectal cancer and proctal cancer, in which pelvic lateral lymph node metastases are suspected by pre-surgical examination (CT/MRI): these pelvic lateral lymph nodes are bigger than 7mm in diameter or are suspected of extra-lymph node invasion. 3) The patients who agreed the entry of this study of their own free will in writing by a principal or a substitute after they had comprehended it well by enough explanation.
Exclusion criteria
Exclusion criteria: 1) The male patients with the middle or the lower rectal cancer, which are not adapted for TaTME and TpTME, which are located far from 6cm from the anal verge. Intra-corporeal transection of the rectum and intra-corporeal anastomosis are possible for rectal cancer. 2) The female patients: for whom the proper surgical field is easy to obtain. There are few cases which LPLLD is hard to achieve, because the female patients usually have the wide pelvis compared to the male. 3) When the proper surgical field or further improvement in manipulation cannot be obtained during TapPLLD, the approach method should be changed into LPLLD. 4) The patients who are inappropriate as the subjects of this study by the corresponding doctor are excluded.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Surgical bleeding and surgical time as the safety criteria, pelvic lateral lymph node harvest as the oncological criterion. | — |
Secondary
| Measure | Time frame |
|---|---|
| Post-surgical complications including dysuria, urinary tract infection, and pelvic abscess, and 3-year local recurrence rate at the pelvic lateral area post PLLD. | — |
Countries
Japan
Contacts
Saku Central Hospital Advanced Care Center Clinical Research Center