Laparoscopic Right ColectomyNCT03422588
Surgical Stress and Intracorporeal Anastomosis
A study testing Laparoscopic right colectomy in people with Laparoscopic Right Colectomy, run by Federico II University at 1 site in Italy.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 100 yearsHealthy volunteers can take part
- Conditions the study is for
- Laparoscopic Right Colectomy
- What is being tested?
- Laparoscopic right colectomy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteItaly
- Study dates
- 1 Jan 2017to 1 Dec 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 100 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- All elective laparoscopic right colectomy for cancer
Who cannot join
- Urgent procedures Immune depressant therapy Immune depressant disease Post-operative Complications
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Intracorporeal Versus Extracorporeal Anastomosis After Laparoscopic Right Colectomy
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.
Read more
Two surgical procedures will be evaluated:
- Totally laparoscopic right colectomy with intracorporeal anastomosis (Experimental group)
- Laparoscopic assisted right colectomy with extracorporeal anastomosis (Control group).
- Conditions
- Laparoscopic Right Colectomy
- Being tested
- Laparoscopic right colectomy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Laparoscopic right colectomyProcedure or surgery
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
| Study group | Role | What they receive |
|---|---|---|
| Intracorporeal | Experimental | Totally laparoscopic right colectomy with intracorporeal anastomosis Receives: Procedure: Laparoscopic right colectomy |
| Extracorporeal | Active comparator | Laparoscopic assisted right colectomy with extracorporeal anastomosis Receives: Procedure: Laparoscopic right colectomy |
What is being measured
The primary outcome is the main question the study is designed to answer.
interleukin 1
Measured: change between time before surgery, 24 hours after surgery, 72 hours after surgery
interleukin 6
Measured: change between time before surgery, 24 hours after surgery, 72 hours after surgery
tumor necrosis factor alpha
Measured: change between time before surgery, 24 hours after surgery, 72 hours after surgery
adrenocorticotropic hormone
Measured: change between time before surgery, 24 hours after surgery, 72 hours after surgery
cortisol
Measured: change between time before surgery, 24 hours after surgery, 72 hours after surgery
insulin
Measured: change between time before surgery, 24 hours after surgery, 72 hours after surgery
glucagon
Measured: change between time before surgery, 24 hours after surgery, 72 hours after surgery
C-reactive protein
Measured: change between time before surgery, 24 hours after surgery, 72 hours after surgery
growth hormone
Measured: change between time before surgery, 24 hours after surgery, 72 hours after surgery
prolactin
Measured: change between time before surgery, 24 hours after surgery, 72 hours after surgery
fibrinogen
Measured: change between time before surgery, 24 hours after surgery, 72 hours after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Feb 2018
- Study start1 Jan 2017
- Primary completion1 Dec 2019
- Study completion1 Dec 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Laparoscopic Right ColectomyStudies of the same condition, open and under way.
- More trials run by Federico II UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Federico II University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Marco Milone, Federico II University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03422588
- Sponsor's protocol ID
- Intrastress-unina
- Status last verified
- Mar 2020
- First submitted
- 30 Jan 2018
- Last updated
- 24 Mar 2020
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 33958669
Study at a glance
From the registry record, last updated by the sponsor on 24 Mar 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Intracorporeal Versus Extracorporeal Anastomosis After Laparoscopic Right Colectomy
- ClinicalTrials.gov ID
- NCT03422588
- Acronym / sponsor ID
- Intrastress-unina
- Conditions
- Laparoscopic Right Colectomy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Federico II UniversityUniversity, hospital or other
- Study start
- 1 Jan 2017 (actual)
- Primary completion
- 1 Dec 2019 (actual)
- Study completion
- 1 Dec 2019 (actual)
- First posted
- 5 Feb 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intracorporeal | Experimental | Procedure: Laparoscopic right colectomyTotally laparoscopic right colectomy with intracorporeal anastomosis |
| Extracorporeal | Active comparator | Procedure: Laparoscopic right colectomyLaparoscopic assisted right colectomy with extracorporeal anastomosis |
Who may qualify
- Ages
- 18 to 100 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- All elective laparoscopic right colectomy for cancer
Key exclusion criteria (1 listed)
- Urgent procedures Immune depressant therapy Immune depressant disease Post-operative Complications
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Laparoscopic right colectomyLaparoscopic 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 | Procedure or surgery | Extracorporeal, Intracorporeal |
Primary outcome
interleukin 1
Time frame: change between time before surgery, 24 hours after surgery, 72 hours after surgery
interleukin 6
Time frame: change between time before surgery, 24 hours after surgery, 72 hours after surgery
tumor necrosis factor alpha
Time frame: change between time before surgery, 24 hours after surgery, 72 hours after surgery
adrenocorticotropic hormone
Time frame: change between time before surgery, 24 hours after surgery, 72 hours after surgery
cortisol
Time frame: change between time before surgery, 24 hours after surgery, 72 hours after surgery
insulin
Time frame: change between time before surgery, 24 hours after surgery, 72 hours after surgery
glucagon
Time frame: change between time before surgery, 24 hours after surgery, 72 hours after surgery
C-reactive protein
Time frame: change between time before surgery, 24 hours after surgery, 72 hours after surgery
growth hormone
Time frame: change between time before surgery, 24 hours after surgery, 72 hours after surgery
prolactin
Time frame: change between time before surgery, 24 hours after surgery, 72 hours after surgery
fibrinogen
Time frame: change between time before surgery, 24 hours after surgery, 72 hours after surgery
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Mar 2020.
- Derived from this study: PubMed 33958669Milone 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.
Related trials for Laparoscopic Right Colectomy
RecruitingObservational study
Leakage Rate of Ileo-COlic Sutured Anastomosis After Right Hemicolectomy
Anastomotic Leak, Colon Cancer
Active, not recruiting
Open D3 Right Hemicolectomy Compared to Laparoscopic CME for Right Sided Colon Cancer
Complication, Quality of Life
Recruiting
Mechanical Bowel Preparation in Laparoscopic Right Hemicolectomy With Intracorporeal Anastomosis
Colon Cancer
Recruiting
LISH Trial for the Hepatic Flexure and Proximal Transverse Colon Cancer
Hepatic Flexure Colon Cancer, Proximal Transverse Colon Cancer
RecruitingObservational study
Laparoscopic Right Hemicolectomy for Crohn's Disease of the Terminal Ileum Utilizing the Mesenteric Excision and Exclusion
Crohn Disease (CD), Crohn Disease of Ileum
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Laparoscopic right colectomy in people with Laparoscopic Right Colectomy, run by Federico II University at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 24 Mar 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
interleukin 1 (time frame: change between time before surgery, 24 hours after surgery, 72 hours after surgery). The study lists 11 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03422588, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Mar 2020.