NCT01427647

Brief Summary

Laparoscopic technique and epidural anesthesia have been proposed to improve postoperative outcome following colorectal cancer surgery. The investigators hypothesize that the inflammatory response is attenuated by laparoscopic surgery and epidural anesthesia compared to traditional open surgery under general anesthesia.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
63

participants targeted

Target at P25-P50 for not_applicable colorectal-cancer

Timeline
Completed

Started Jun 2007

Typical duration for not_applicable colorectal-cancer

Geographic Reach
1 country

1 active site

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

June 1, 2007

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2009

Completed
9 months until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2010

Completed
1.6 years until next milestone

First Submitted

Initial submission to the registry

August 29, 2011

Completed
3 days until next milestone

First Posted

Study publicly available on registry

September 1, 2011

Completed
Last Updated

July 22, 2016

Status Verified

July 1, 2016

Enrollment Period

1.9 years

First QC Date

August 29, 2011

Last Update Submit

July 21, 2016

Conditions

Colorectal Cancer

Keywords

LaparoscopyAnesthesia, Epidural

Outcome Measures

Primary Outcomes (1)

  • Plasma levels of several cytokines after colorectal cancer surgery

    We have measured and compared perioperative plasma levels of interleukin-1, interleukin-2, interleukin-6,monocyte chemotactic protein-1, interleukin-8, nitric oxide, C-reactive protein and procalcitonin in our three-group sample.

    within the first two days after surgery

Secondary Outcomes (1)

  • Incidence of adverse clinical outcomes between groups

    within 30 days after surgery

Study Arms (3)

Control group

ACTIVE COMPARATOR

Control group: open surgery under general anesthesia

Procedure: Laparoscopic technique and thoracic epidural anesthesia

Epidural group

ACTIVE COMPARATOR

Epidural group: Open surgery under thoracic epidural anesthesia

Procedure: Laparoscopic technique and thoracic epidural anesthesia

Laparoscopic group

ACTIVE COMPARATOR

Laparoscopic group: Laparoscopic surgery under general anesthesia

Procedure: Laparoscopic technique and thoracic epidural anesthesia

Interventions

Laparoscopic technique and thoracic epidural anesthesiaPROCEDURE

We have compared colorectal cancer surgery under two types of surgical(laparoscopic versus open) and anesthesia (thoracic epidural versus general) techniques

Control groupEpidural groupLaparoscopic group

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patients scheduled for colorectal cancer surgery

You may not qualify if:

  • Emergent surgery
  • Intestinal obstruction
  • Contraindication for epidural catheter placement
  • Concomitant autoimmune disease
  • Concomitant infectious disease
  • Recent corticosteroids or anti-inflammatory medications

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Gregorio Marañon Hospital

Madrid, Madrid, 28007, Spain

Location

MeSH Terms

Conditions

Colorectal Neoplasms

Condition Hierarchy (Ancestors)

Intestinal NeoplasmsGastrointestinal NeoplasmsDigestive System NeoplasmsNeoplasms by SiteNeoplasmsDigestive System DiseasesGastrointestinal DiseasesColonic DiseasesIntestinal DiseasesRectal Diseases

Study Officials

  • Patricia Duque, MD

    Gregorio Marañon Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
FACTORIAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Anesthesiologist staff

Study Record Dates

First Submitted

August 29, 2011

First Posted

September 1, 2011

Study Start

June 1, 2007

Primary Completion

May 1, 2009

Study Completion

February 1, 2010

Last Updated

July 22, 2016

Record last verified: 2016-07

Locations

ES(1)