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Transanal or transperineal pelvic lateral lymph node dissection for lower rectal cancer and proctal cancer

Transanal or transperineal pelvic lateral lymph node dissection for lower rectal cancer and proctal cancer - Transanal or transperineal pelvic lateral lymph node dissection

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
JPRN
Registry ID
JPRN-UMIN000029228
Enrollment
10
Registered
2017-09-22
Start date
2017-11-07
Completion date
Unknown
Last updated
2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Lower Rectal Cancer and Proctal Cancer

Interventions

Transanal or transperineal pelvic lateral lymph node dissection

Sponsors

Saku Central Hospital Advanced Care Center
Lead Sponsor

Eligibility

Sex/Gender
Male

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

MeasureTime frame
Surgical bleeding and surgical time as the safety criteria, pelvic lateral lymph node harvest as the oncological criterion.

Secondary

MeasureTime 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

Public ContactMiyuki Niimi

Saku Central Hospital Advanced Care Center Clinical Research Center

ctroffice@sakuhp.or.jp0267-62-8181

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026