Surgical Stress and Colorectal Surgery

NCT ID: NCT02871960

Last Updated: 2020-01-22

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

170 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-01-31

Study Completion Date

2020-11-30

Brief Summary

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The purpose of this study is to evaluate surgical stress and immune function after robotic versus laparoscopic colectomy.

Detailed Description

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The short-term advantages of minimally invasive colon resection have been well established in several randomized trials. A major factor in the development of morbidity is the surgical stress response with subsequent increased demand on the patient's reserves and immune competence. Although the advantage in term of stress response of laparoscopic surgery over open surgery has been widely reported, little is known about the role of robotic surgery.

Robotic approaches have seen significant growth in the last 5 years. Taking advantage of three-dimensional visualization, improved articulation, and multiple operating arms provides theoretical advantages in colorectal cancer surgery. In an attempt to evaluate the surgical stress response and immune function after robotic colorectal surgery a comparative study has been designed. Two surgical procedures were evaluated: Robotic colorectal resection (Experimental group) and Laparoscopic colorectal resection (Control group).

Conditions

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Surgical Stress and Immune Function

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

Study Groups

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Robotic colectomy

Patients undergoing robotic colectomy for colorectal cancer

Group Type EXPERIMENTAL

Robotic and Laparoscopic Colectomy

Intervention Type PROCEDURE

Laparoscopic colectomy

Patients undergoing laparoscopic colectomy for colorectal cancer

Group Type ACTIVE_COMPARATOR

Robotic and Laparoscopic Colectomy

Intervention Type PROCEDURE

Interventions

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Robotic and Laparoscopic Colectomy

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

* Eligible patients will be those with a histologically confirmed malignancy planned for an elective, segmental, curative colectomy
Minimum Eligible Age

50 Years

Maximum Eligible Age

90 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Federico II University

OTHER

Sponsor Role lead

Responsible Party

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Francesco Milone

Professor of Surgery

Responsibility Role PRINCIPAL_INVESTIGATOR

Other Identifiers

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RoboticUnina2016

Identifier Type: -

Identifier Source: org_study_id

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