Surgical Stress and Intracorporeal Anastomosis

NCT ID: NCT03422588

Last Updated: 2020-03-24

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

COMPLETED

Clinical Phase

NA

Total Enrollment

20 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-01-01

Study Completion Date

2019-12-01

Brief Summary

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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 Intracorporeal anastomosis.

In an attempt to evaluate the surgical stress response after totally laparoscopic right colectomy a comparative study has been designed.

Two surgical procedures will be evaluated:

* Totally laparoscopic right colectomy with intracorporeal anastomosis (Experimental group)
* Laparoscopic assisted right colectomy with extracorporeal anastomosis (Control group).

Detailed Description

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Conditions

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Laparoscopic Right Colectomy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Intracorporeal

Totally laparoscopic right colectomy with intracorporeal anastomosis

Group Type EXPERIMENTAL

Laparoscopic right colectomy

Intervention Type PROCEDURE

Laparoscopic right colectomy for colorectal cancer with a standard vascular dissection, performing the anastomosis with a side-to-side mechanical anastomosis fashioned intracorporeally versus extra corporeally

Extracorporeal

Laparoscopic assisted right colectomy with extracorporeal anastomosis

Group Type ACTIVE_COMPARATOR

Laparoscopic right colectomy

Intervention Type PROCEDURE

Laparoscopic right colectomy for colorectal cancer with a standard vascular dissection, performing the anastomosis with a side-to-side mechanical anastomosis fashioned intracorporeally versus extra corporeally

Interventions

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Laparoscopic right colectomy

Laparoscopic right colectomy for colorectal cancer with a standard vascular dissection, performing the anastomosis with a side-to-side mechanical anastomosis fashioned intracorporeally versus extra corporeally

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

All elective laparoscopic right colectomy for cancer

Exclusion Criteria

Urgent procedures Immune depressant therapy Immune depressant disease Post-operative Complications
Minimum Eligible Age

18 Years

Maximum Eligible Age

100 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Federico II University

OTHER

Sponsor Role lead

Responsible Party

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Marco Milone

Professor of Surgery (MD, PhD)

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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University of Naples Federico II

Naples, , Italy

Site Status

Countries

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Italy

References

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Milone M, Desiderio A, Velotti N, Manigrasso M, Vertaldi S, Bracale U, D'Ambra M, Servillo G, De Simone G, De Palma FDE, Perruolo G, Raciti GA, Miele C, Beguinot F, De Palma GD. Surgical stress and metabolic response after totally laparoscopic right colectomy. Sci Rep. 2021 May 6;11(1):9652. doi: 10.1038/s41598-021-89183-7.

Reference Type DERIVED
PMID: 33958669 (View on PubMed)

Other Identifiers

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Intrastress-unina

Identifier Type: -

Identifier Source: org_study_id

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