Surgical Stress and Immune FunctionESSIMICNCT02871960
Surgical Stress and Colorectal Surgery
A study testing Robotic and Laparoscopic Colectomy in people with Surgical Stress and Immune Function, run by Federico II University.
Trial summary
The purpose of this study is to evaluate surgical stress and immune function after robotic versus laparoscopic colectomy. Read more about this study
- Who is it for?
- Ages 50 to 90 years
- Conditions the study is for
- Surgical Stress and Immune Function
- What is being tested?
- Robotic and Laparoscopic Colectomy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 170 participants
- Where
- No sites listed yet
- Study dates
- Jan 2016to Nov 2020
- 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 50 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Eligible patients will be those with a histologically confirmed malignancy planned for an elective, segmental, curative colectomy
Who cannot join
- Patients with a previous midline laparotomy, emergency surgery, or immune depressant disease or medication will be excluded from this study. Peri-operative or post-operative complications will be considered exclusion criteria.
About this study
Official title: Evaluation of Surgical Stress and Immune Response After Minimally Invasive Colorectal Surgery (ESSIMIC)
The purpose of this study is to evaluate surgical stress and immune function after robotic versus laparoscopic colectomy.
Read the detailed description
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
- Surgical Stress and Immune Function
- Being tested
- Robotic and Laparoscopic Colectomy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Robotic and Laparoscopic ColectomyProcedure or surgery
| Study group | Role | What they receive |
|---|---|---|
| Robotic colectomy | Experimental | Patients undergoing robotic colectomy for colorectal cancer Receives: Procedure: Robotic and Laparoscopic Colectomy |
| Laparoscopic colectomy | Active comparator | Patients undergoing laparoscopic colectomy for colorectal cancer Receives: Procedure: Robotic and Laparoscopic 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
C-reactive protein
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
prolactin
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
Adrenocorticotropic hormone
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
human leukocyte antigen
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 posted18 Aug 2016 (estimated)
- Study startJan 2016
- Primary completionAug 2020 (estimated)
- Study completionNov 2020 (estimated)
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 Surgical Stress and Immune FunctionStudies 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
- Single blind
- Who is masked
- Participant
- Enrolment
- 170 participants (actual)
Sponsor and investigators
- Lead sponsor
- Federico II University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Francesco Milone, Federico II University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02871960
- Sponsor's protocol ID
- RoboticUnina2016
- Acronym
- ESSIMIC
- Status last verified
- Dec 2019
- First submitted
- 21 Jul 2016
- Last updated
- 22 Jan 2020
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Milone M, Vertaldi S, Anoldo P, Borin S, Ceccarelli G, D'Amore A, Degiuli M, Delrio P, Fumagalli UR, Guerrieri M, Manigrasso M, Ortenzi M, Pace U, Pirozzi F, Puca L, Petz W, Reddavid R, Rega D, Rondelli F, Sciuto A, De Palma GD. Interim analysis of short-term outcomes between robotic and laparoscopic surgery for colon cancer: results from the ESSIMIC trial. Ann Coloproctol. 2026 Feb;42(1):86-93. doi: 10.3393/ac.2025.00339.0048. Epub 2026 Feb 23.
PubMed 41802309
Study at a glance
From the registry record, last updated by the sponsor on 22 Jan 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Surgical Stress and Immune Response After Minimally Invasive Colorectal Surgery (ESSIMIC)
- ClinicalTrials.gov ID
- NCT02871960
- Acronym / sponsor ID
- ESSIMIC / RoboticUnina2016
- Conditions
- Surgical Stress and Immune Function
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 170 participants (actual)
- Lead sponsor
- Federico II UniversityUniversity, hospital or other
- Study start
- Jan 2016
- Primary completion
- Aug 2020 (estimated)
- Study completion
- Nov 2020 (estimated)
- First posted
- 18 Aug 2016 (estimated)
- 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 purpose of this study is to evaluate surgical stress and immune function after robotic versus laparoscopic colectomy.
Detailed description
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).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Robotic colectomy | Experimental | Procedure: Robotic and Laparoscopic ColectomyPatients undergoing robotic colectomy for colorectal cancer |
| Laparoscopic colectomy | Active comparator | Procedure: Robotic and Laparoscopic ColectomyPatients undergoing laparoscopic colectomy for colorectal cancer |
Who may qualify
- Ages
- 50 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Eligible patients will be those with a histologically confirmed malignancy planned for an elective, segmental, curative colectomy
Key exclusion criteria (1 listed)
- Patients with a previous midline laparotomy, emergency surgery, or immune depressant disease or medication will be excluded from this study. Peri-operative or post-operative complications will be considered exclusion criteria.
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 |
|---|---|---|
| Robotic and Laparoscopic Colectomy | Procedure or surgery | Laparoscopic colectomy, Robotic colectomy |
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
C-reactive protein
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
prolactin
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
Adrenocorticotropic hormone
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
human leukocyte antigen
Time frame: change between time before surgery, 24 hours after surgery, 72 hours after surgery
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Jan 2020.
- Derived from this study: PubMed 41802309Milone M, Vertaldi S, Anoldo P, Borin S, Ceccarelli G, D'Amore A, Degiuli M, Delrio P, Fumagalli UR, Guerrieri M, Manigrasso M, Ortenzi M, Pace U, Pirozzi F, Puca L, Petz W, Reddavid R, Rega D, Rondelli F, Sciuto A, De Palma GD. Interim analysis of short-term outcomes between robotic and laparoscopic surgery for colon cancer: results from the ESSIMIC trial. Ann Coloproctol. 2026 Feb;42(1):86-93. doi: 10.3393/ac.2025.00339.0048. Epub 2026 Feb 23.
- Individual participant dataSharing planned: Undecided
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.
Questions about this trial
What is this clinical trial studying?
A study testing Robotic and Laparoscopic Colectomy in people with Surgical Stress and Immune Function, run by Federico II University.
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: status not confirmed, as of the sponsor's last update on 22 Jan 2020. Status can change between updates, so confirm with the study contact before making plans.
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?
Results are not available in the source record.
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 12 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 NCT02871960, 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 22 Jan 2020.