Prospective Phase II Trial of Laparoscopic Surgery for Ultra-low Rectal Cancers within Five Centimeters from the Anus or Three Centimeters from the Dentate Line

Prospective Phase II Trial of Laparoscopic Surgery for Ultra-low Rectal Cancers within Five Centimeters from the Anus or Three Centimeters from the Dentate Line - Prospective Phase II Trial of Laparoscopic Surgery for Ultra-low Rectal Cancers within Five Centimeters from the Anus or Three Centimeters from the Dentate Line

Status

Active, not recruiting

Phases

Unknown

Study type

Observational

Source

JPRN

Registry ID

JPRN-UMIN000011750

Enrollment

300

Registered

2013-09-13

Start date

2013-11-01

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

Rectal cancer

Interventions

None listed

Sponsors

Japanese Society for Cancer of the Colon and Rectum

Lead Sponsor

Ishikawa Prefectural Central Hospital, Imate Medical University, Ehime Prefectural Central Hospital, Oita University, Osaka University, Osaka Medical University, Osaka Red Cross Hospital, Osaka Rosai Hospital, Kagawa Prefectural Central Hospital, Kagawa University, Kawasaki Medical University, The Cancer Institute Hospital of JFCR, Kansai Rosai Hospital, Kitasato University, Kyushu University, Kyoto University, Kyoto Medical Center, Kyoto Prefectural University of Medicine, Kyorin University, Ki

Collaborator

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1.Histologically confirmed adenocarcinoma of the rectum 2.Lower border of the tomor is within five centimeter from the anus or three cemtimeter from the dentate line 3.c-T1-2N0M0 stage I(TNM7th) 4.Aged 20 years old or over 5.Possible to curative resection 6.Operable general status and organ function 7.PS(ECOG) of 0 or 1 8.No prior chemotherapy or radiation therapy. 9.Written informed consent

Exclusion criteria

Exclusion criteria: 1.Hope for laparotomy 2.Preoperative severe disorder of anal function and supposed postoperative disorder 3.Synchronous or metachronous (within 5 years) malignancies other than carcinoma in situ or mucosal carcinoma. 4.Uncontrollable diabetes mellitus or hypertension. Interstitial lung disease, pulmonary fibrosis or severe emphysema. 5.Severe mental disease. 6.Impossible to written informed consent 7.Doctor' s decision for exclusion

Design outcomes

Primary

Measure	Time frame
Local recurrence in three years	—

Secondary

Measure	Time frame
1, Recurrence free survival 2, Overall survival 3, Defecation, urinary and sexualfunction , QOL 4, Rate of anal preservation 5, Adverse effect	—

Countries

Japan

Contacts

Public ContactMasaaki Ito

National Cancer Center Hospital East Colorectal Surgery

maito@east.ncc.go.jp04-7133-1111

Outcome results