Clinical trial · Interventional

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

NCT00782457CI-TRIAL-00017164completedPhase 3ClinicalTrials.gov clinicaltrialsPublishedExplore in graph →

Summary

Brief summary (as posted)

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.

Conditions

Conditions (1)

Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.

Condition (as posted)	Mapped entity	Match	Confidence
RECTAL CANCER	Malignant Rectal Neoplasm	CURATED_EXACT	0.92

Interventions

Interventions (1)

Intervention	Type	Mapped drug	Match
RECTAL CANCER RESECTION	Procedure	—	UNRESOLVED

Design

Arms and outcomes

Arms (2)

type
ACTIVE_COMPARATOR
label
OPEN SURGERY
interventionNames
1. Procedure: RECTAL CANCER RESECTION
type
EXPERIMENTAL
label
LAPAROSCOPIC SURGERY
interventionNames
1. Procedure: RECTAL CANCER RESECTION

Primary outcomes (1)

measure
Lymph nodes isolated, circumferential margin involved, rate of complications and length of stay
timeFrame
1 month

Eligibility

Eligibility (as posted)

Sex: All

Show eligibility criteria text

Inclusion Criteria:

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

Exclusion Criteria:

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

References

Publications (1)

DERIVEDLujan 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 19644973