NCT00782457

Brief Summary

The aim of this study is to compare laparoscopic versus open approach on the surgical treatment of mid and low-lying rectal cancer, both performed by the same surgical team with experience in open colorectal surgery and advanced laparoscopic surgery, assessing preoperative and anatomopathological results and long-term outcome.

Trial Health

100
On Track

Trial Health Score

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

Enrollment
200

participants targeted

Target at P25-P50 for phase_3

Timeline
Completed

Started Jan 2002

Longer than P75 for phase_3

Status
completed

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

January 1, 2002

Completed
5.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2007

Completed
1.7 years until next milestone

First Submitted

Initial submission to the registry

October 29, 2008

Completed
2 days until next milestone

First Posted

Study publicly available on registry

October 31, 2008

Completed
2.1 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2010

Completed
Last Updated

March 18, 2015

Status Verified

October 1, 2008

Enrollment Period

5.1 years

First QC Date

October 29, 2008

Last Update Submit

March 17, 2015

Conditions

RECTAL CANCER

Outcome Measures

Primary Outcomes (1)

  • Lymph nodes isolated, circumferential margin involved, rate of complications and length of stay

    1 month

Study Arms (2)

OPEN SURGERY

ACTIVE COMPARATOR
Procedure: RECTAL CANCER RESECTION

LAPAROSCOPIC SURGERY

EXPERIMENTAL
Procedure: RECTAL CANCER RESECTION

Interventions

RECTAL CANCER RESECTIONPROCEDURE
LAPAROSCOPIC SURGERYOPEN SURGERY

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Mid- and low-lying rectal cancer (between 0 and 11 cm from the anal margin)
  • Histology of adenocarcinoma

You may not qualify if:

  • Locally advanced disease (T4)
  • Emergency surgery
  • Rectal cancer over familial colic polyposis

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (1)

  • Lujan J, Valero G, Hernandez Q, Sanchez A, Frutos MD, Parrilla P. Randomized clinical trial comparing laparoscopic and open surgery in patients with rectal cancer. Br J Surg. 2009 Sep;96(9):982-9. doi: 10.1002/bjs.6662.

    PMID: 19644973DERIVED

MeSH Terms

Conditions

Rectal Neoplasms

Condition Hierarchy (Ancestors)

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

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

October 29, 2008

First Posted

October 31, 2008

Study Start

January 1, 2002

Primary Completion

February 1, 2007

Study Completion

December 1, 2010

Last Updated

March 18, 2015

Record last verified: 2008-10