NCT03422588

Brief Summary

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).

Trial Health

87
On Track

Trial Health Score

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

Enrollment
20

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jan 2017

Typical duration for not_applicable

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

January 1, 2017

Completed
1.1 years until next milestone

First Submitted

Initial submission to the registry

January 30, 2018

Completed
6 days until next milestone

First Posted

Study publicly available on registry

February 5, 2018

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2019

Completed
Last Updated

March 24, 2020

Status Verified

March 1, 2020

Enrollment Period

2.9 years

First QC Date

January 30, 2018

Last Update Submit

March 23, 2020

Conditions

Laparoscopic Right Colectomy

Outcome Measures

Primary Outcomes (11)

  • interleukin 1

    change between time before surgery, 24 hours after surgery, 72 hours after surgery

  • interleukin 6

    change between time before surgery, 24 hours after surgery, 72 hours after surgery

  • tumor necrosis factor alpha

    change between time before surgery, 24 hours after surgery, 72 hours after surgery

  • adrenocorticotropic hormone

    change between time before surgery, 24 hours after surgery, 72 hours after surgery

  • cortisol

    change between time before surgery, 24 hours after surgery, 72 hours after surgery

  • insulin

    change between time before surgery, 24 hours after surgery, 72 hours after surgery

  • glucagon

    change between time before surgery, 24 hours after surgery, 72 hours after surgery

  • C-reactive protein

    change between time before surgery, 24 hours after surgery, 72 hours after surgery

  • growth hormone

    change between time before surgery, 24 hours after surgery, 72 hours after surgery

  • prolactin

    change between time before surgery, 24 hours after surgery, 72 hours after surgery

  • fibrinogen

    change between time before surgery, 24 hours after surgery, 72 hours after surgery

Study Arms (2)

Intracorporeal

EXPERIMENTAL

Totally laparoscopic right colectomy with intracorporeal anastomosis

Procedure: Laparoscopic right colectomy

Extracorporeal

ACTIVE COMPARATOR

Laparoscopic assisted right colectomy with extracorporeal anastomosis

Procedure: Laparoscopic right colectomy

Interventions

Laparoscopic right colectomyPROCEDURE

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

ExtracorporealIntracorporeal

Eligibility Criteria

Age18 Years - 100 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • All elective laparoscopic right colectomy for cancer

You may not qualify if:

  • Urgent procedures Immune depressant therapy Immune depressant disease Post-operative Complications

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Naples Federico II

Naples, 80131, Italy

Location

Related Publications (1)

  • 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.

    PMID: 33958669DERIVED

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor of Surgery (MD, PhD)

Study Record Dates

First Submitted

January 30, 2018

First Posted

February 5, 2018

Study Start

January 1, 2017

Primary Completion

December 1, 2019

Study Completion

December 1, 2019

Last Updated

March 24, 2020

Record last verified: 2020-03

Locations

IT(1)