NCT00635466

Brief Summary

The purpose of this study is to examine the technical and oncological feasibility of laparoscopic surgery for rectal carcinoma

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
495

participants targeted

Target at P75+ for phase_2

Timeline
Completed

Started Feb 2008

Longer than P75 for phase_2

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2008

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

March 6, 2008

Completed
7 days until next milestone

First Posted

Study publicly available on registry

March 13, 2008

Completed
7.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2015

Completed
Last Updated

June 16, 2011

Status Verified

June 1, 2011

Enrollment Period

7.6 years

First QC Date

March 6, 2008

Last Update Submit

June 15, 2011

Conditions

Rectal Cancer

Keywords

laparoscopic surgery, rectal carcinoma, phase II trial

Outcome Measures

Primary Outcomes (1)

  • overall survival

    5 year

Secondary Outcomes (1)

  • anastomotic leakage rate

    1 month

Study Arms (1)

Lap, 1

EXPERIMENTAL

Patients undergoing laparoscopic surgery for rectal carcinoma

Procedure: laparoscopic surgery for rectal carcinoma

Interventions

laparoscopic surgery for rectal carcinomaPROCEDURE

Laparoscopic resection of the rectum with adequate lymphadenectomy is performed according to the General Rules for Clinical and Pathological Studies on Cancer of the Colon, Rectum and Anus edited by the Japanese Society for Cancer of the Colon and Rectum. The extent of lymphadenectomy and site of ligation and division of the inferior mesenteric vessels were decided by the surgeon in charge. Pneumoperitoneal approaches are used to explore the abdomen, mobilize the left side colon, identify critical structures and ligate the vascular pedicle. Mobilization of the rectum, excision of the mesorectum, rectal transection, removal of the specimen, and reconstruction are performed by the pneumoperitoneal approach or the extracorporeal approach via a small incision (\<8 cm).

Also known as: laparoscopic rectal resection
Lap, 1

Eligibility Criteria

Age20 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Histologically proven rectal carcinoma.
  • Tumor located in the rectum.
  • Clinical Tis, T1, T2 N0 M0
  • Without multiple lesions other than carcinoma in situ
  • Tumor size \<8 cm.
  • Sufficient organ function.
  • No bowel obstruction.
  • No history of major colorectal surgery.
  • No history of chemotherapy or radiotherapy.
  • Provide written informed consent.

You may not qualify if:

  • Synchronous or metachronous (within 5 years) malignancy other than carcinoma in situ.
  • Pregnant or lactating women.
  • Severe mental disease.
  • Severe pulmonary emphysema, interstitial pneumonitis or ischemic heart disease.
  • Continuous systemic steroid therapy.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Kitasato University Hospital

Sagamihara, Kanagawa, 228-8555, Japan

Location

Related Publications (3)

  • Yamamoto S, Yoshimura K, Konishi F, Watanabe M. Phase II trial to evaluate laparoscopic surgery for Stage 0/I rectal carcinoma. Jpn J Clin Oncol. 2008 Jul;38(7):497-500. doi: 10.1093/jjco/hyn054. Epub 2008 Jun 26.

    PMID: 18586667BACKGROUND

  • Ito M, Yamamoto S, Okuda J, Fujii S, Yamaguchi S, Otsuka K, Yoshimura K, Watanabe M; Japan Society of Laparoscopic Colorectal Surgery. Long-term survival outcomes following laparoscopic surgery for clinical stage 0/I rectal carcinoma. Ann Gastroenterol Surg. 2020 May 20;4(3):294-300. doi: 10.1002/ags3.12333. eCollection 2020 May.

    PMID: 32490343DERIVED

  • Yamamoto S, Ito M, Okuda J, Fujii S, Yamaguchi S, Yoshimura K, Sugihara K, Watanabe M; Japan Society of Laparoscopic Colorectal Surgery. Laparoscopic surgery for stage 0/I rectal carcinoma: short-term outcomes of a single-arm phase II trial. Ann Surg. 2013 Aug;258(2):283-8. doi: 10.1097/SLA.0b013e318283669c.

    PMID: 23426337DERIVED

Related Links

MeSH Terms

Conditions

Rectal Neoplasms

Interventions

Laparoscopy

Condition Hierarchy (Ancestors)

Colorectal NeoplasmsIntestinal NeoplasmsGastrointestinal NeoplasmsDigestive System NeoplasmsNeoplasms by SiteNeoplasmsDigestive System DiseasesGastrointestinal DiseasesIntestinal DiseasesRectal Diseases

Intervention Hierarchy (Ancestors)

EndoscopyDiagnostic Techniques, SurgicalDiagnostic Techniques and ProceduresDiagnosisMinimally Invasive Surgical ProceduresSurgical Procedures, Operative

Study Officials

  • Masahiko Watanabe, PhD

    Kitasato University Hospital

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
NETWORK

Study Record Dates

First Submitted

March 6, 2008

First Posted

March 13, 2008

Study Start

February 1, 2008

Primary Completion

September 1, 2015

Study Completion

September 1, 2015

Last Updated

June 16, 2011

Record last verified: 2011-06

Locations

JP(1)