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CompletedNCT00782457Updated Mar 18, 2015

Prospective Randomised Study Comparing Laparoscopic Versus Open Surgery in Patients With Rectal Cancer

A Phase 3 interventional study of RECTAL CANCER RESECTION in RECTAL CANCER, sponsored by Hospital Universitario Virgen de la Arrixaca. Completed. Per ClinicalTrials.gov, last updated 2015-03-18.

Sponsored by Hospital Universitario Virgen de la Arrixaca · Phase 3, Interventional, and Treatment

Phase
Phase 3
Study type
Interventional
Enrollment
200
Allocation
Randomized
Sex
All
01

Study 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.

02

Conditions studied

  • RECTAL CANCER

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03

In context

Rectal Neoplasms

1,762 studies on the registry are indexed under Rectal Neoplasms; 518 are open to participants now.

This study's planned enrollment of 200 is above the median of 65 across 1,298 interventional studies indexed under Rectal Neoplasms.

Browse Rectal Neoplasms studies →

Lead sponsor

Hospital Universitario Virgen de la Arrixaca is the lead sponsor of 25 studies on the registry; 2 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
Child (0–17), Adult (18–64), Older adult (65+)
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

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

Exclusion criteria

Exclusion Criteria:

  • Locally advanced disease (T4)
  • Emergency surgery
  • Rectal cancer over familial colic polyposis
05

Study design

Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
200 participants (estimated)

Study arms

  • Active comparator
    OPEN SURGERY

    Procedure: RECTAL CANCER RESECTION

  • Experimental
    LAPAROSCOPIC SURGERY

    Procedure: RECTAL CANCER RESECTION

Interventions

  • ProcedureRECTAL CANCER RESECTION
06

What researchers measure

Primary outcomes

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

    Time frame: 1 month

07

Study locations

No study locations are listed for this record.

08

References and documents

Publications

  • 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. PubMed 19644973 ↗
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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Mar 18, 2015, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT00782457
Lead sponsor
Hospital Universitario Virgen de la Arrixaca
First posted
Oct 31, 2008
Start date
Jan 2002
Primary completion
Feb 2007
Completion
Dec 2010
Last update
Mar 18, 2015
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Oct 2008. You cannot join it, but the record below documents what was studied.

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