Colorectal CancerNCT06540027
The Effect of Minimally Invasive Surgery on Systemic Inflammatory Response in Rectal Cancer
An observational study of Colorectal Cancer and Colorectal Adenocarcinoma, run by Başakşehir Çam & Sakura City Hospital at 1 site in Turkey (Türkiye).
Trial summary
As a hypothesis and shown in many meta-analyses and randomized controlled studies, minimally invasive surgery causes less surgical trauma and therefore less proinflammatory response and immunosuppression develop, and postoperative recovery is faster. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Colorectal Cancer, Colorectal Adenocarcinoma, Rectal Cancer
- What is being tested?
- rectal cacer surgery
- Type of treatment
- Surgery or procedure
- How many people
- 80 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Jun 2024to 1 Mar 2025
- How long will I take part?
- 1 Week
- Phase
- Observational
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Patients operated with minimally invasive surgery
Who may be able to join
- Patients operated for rectal cancer
- Open surgery
- Laparoscopic surgery
- Robotic surgery
Who cannot join
- Patients with diagnosed immune deficiency
- Patients with recurrent colorectal cancer
- Patients with co-existent tumors
Trial locations and contacts
1 site in 1 country.
About this study
As a hypothesis and shown in many meta-analyses and randomized controlled studies, minimally invasive surgery causes less surgical trauma and therefore less proinflammatory response and immunosuppression develop, and postoperative recovery is faster. Although various prognostic studies on the relationship between gastrointestinal cancer types and SII (systemic inflammatory index) and the use of minimally invasive surgery have been published, the high level of this response and the type of surgery in the treatment of colorectal cancer have not yet been shown to have a direct effect on SII.
Read the detailed description
Minimally invasive surgery has been demonstrated to significantly enhance the host immune response in colorectal cancer. The effect and the SII marker may be reliable indicators of this enhancement. A retrospective analysis was conducted on the records of patients who underwent surgery for colorectal cancer at our clinic over a four-year period. The patients were divided into three groups according to the surgical approach employed: open surgery, laparoscopic surgery and robotic surgery.
The primary outcome is: A comparison of the open surgery group with those undergoing minimally invasive surgery (laparoscopic and robotic) revealed lower SII values in the robotic surgery group than in the laparoscopic surgery group.
The secondary outcome : The SII values were determined as neutrophil/lymphocyte and platelet/lymphocyte, which had been previously investigated in other studies.
A comparison will be made with the relevant markers. The research team adheres to the principles set forth in the Declaration of Helsinki and Good Clinical Practice guidelines. They will conduct the study in an appropriate manner.
No intervention will be made in the follow-up and treatment of patients, in accordance with the approval of the hospital ethics committee.
The laboratory records typically examined in the postoperative phase will be re-examined in a retrospective manner. Furthermore, the personal data of the participants will not be incorporated into the study.
- Conditions
- Colorectal Cancer, Colorectal Adenocarcinoma, Rectal Cancer, Rectal Cancer Stage, Immune System Disorder
- Being tested
- rectal cacer surgery
- Keywords
- minimally invasive surgery, robotic surgery, colorectal cancer, immune system response
- Medical subject headings
- Colorectal Neoplasms, Rectal Neoplasms, Immune System Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
rectal cacer surgeryProcedure or surgery
minimally invasive surgery
| Study group | Role | What they receive |
|---|---|---|
| Control group | Patients with rectal cancer, open surgery Receives: Procedure: rectal cacer surgery | |
| Study group 1 | Patients with rectal cancer, laparoscopic surgery Receives: Procedure: rectal cacer surgery | |
| Study group 2 | Patients with rectal cancer, robotic surgery Receives: Procedure: rectal cacer surgery |
What is being measured
The primary outcome is the main question the study is designed to answer.
immune response
the level of SII
Measured: 1 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Aug 2024
- Study start1 Jun 2024
- Primary completion30 Dec 2024 (estimated)
- Study completion1 Mar 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Colorectal CancerStudies of the same condition, open and under way.
- 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 80 participants (estimated)
- Target duration
- 1 Week
Sponsor and investigators
- Lead sponsor
- Başakşehir Çam & Sakura City Hospital
- Sponsor type
- Other government
- Responsible party
- Sponsor
- Investigators
- Serkan Sari, Prof, Study chair, Basaksehir Cith Hospital, Istanbul, Turkey
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06540027
- Sponsor's protocol ID
- basaksehir2024-37
- Status last verified
- Jul 2024
- First submitted
- 2 Aug 2024
- Last updated
- 15 Aug 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Minimally Invasive Surgery on Systemic Inflammatory Response in Rectal Cancer
- ClinicalTrials.gov ID
- NCT06540027
- Acronym / sponsor ID
- basaksehir2024-37
- Conditions
- Colorectal Cancer, Colorectal Adenocarcinoma, Rectal Cancer, Rectal Cancer Stage, Immune System Disorder
- Keywords
- minimally invasive surgery, robotic surgery, colorectal cancer, immune system response
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- Başakşehir Çam & Sakura City HospitalOther government
- Study start
- 1 Jun 2024 (actual)
- Primary completion
- 30 Dec 2024 (estimated)
- Study completion
- 1 Mar 2025 (estimated)
- First posted
- 6 Aug 2024 (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.
As a hypothesis and shown in many meta-analyses and randomized controlled studies, minimally invasive surgery causes less surgical trauma and therefore less proinflammatory response and immunosuppression develop, and postoperative recovery is faster. Although various prognostic studies on the relationship between gastrointestinal cancer types and SII (systemic inflammatory index) and the use of minimally invasive surgery have been published, the high level of this response and the type of surgery in the treatment of colorectal cancer have not yet been shown to have a direct effect on SII.
Detailed description
Minimally invasive surgery has been demonstrated to significantly enhance the host immune response in colorectal cancer. The effect and the SII marker may be reliable indicators of this enhancement. A retrospective analysis was conducted on the records of patients who underwent surgery for colorectal cancer at our clinic over a four-year period. The patients were divided into three groups according to the surgical approach employed: open surgery, laparoscopic surgery and robotic surgery.
The primary outcome is: A comparison of the open surgery group with those undergoing minimally invasive surgery (laparoscopic and robotic) revealed lower SII values in the robotic surgery group than in the laparoscopic surgery group.
The secondary outcome : The SII values were determined as neutrophil/lymphocyte and platelet/lymphocyte, which had been previously investigated in other studies.
A comparison will be made with the relevant markers. The research team adheres to the principles set forth in the Declaration of Helsinki and Good Clinical Practice guidelines. They will conduct the study in an appropriate manner.
No intervention will be made in the follow-up and treatment of patients, in accordance with the approval of the hospital ethics committee.
The laboratory records typically examined in the postoperative phase will be re-examined in a retrospective manner. Furthermore, the personal data of the participants will not be incorporated into the study.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 1 Week
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Control group | – | Procedure: rectal cacer surgeryPatients with rectal cancer, open surgery |
| Study group 1 | – | Procedure: rectal cacer surgeryPatients with rectal cancer, laparoscopic surgery |
| Study group 2 | – | Procedure: rectal cacer surgeryPatients with rectal cancer, robotic surgery |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Patients operated with minimally invasive surgery
Key inclusion criteria (4 listed)
- Patients operated for rectal cancer
- Open surgery
- Laparoscopic surgery
- Robotic surgery
Key exclusion criteria (3 listed)
- Patients with diagnosed immune deficiency
- Patients with recurrent colorectal cancer
- Patients with co-existent tumors
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 |
|---|---|---|
| rectal cacer surgeryminimally invasive surgery | Procedure or surgery | Control group, Study group 1, Study group 2 |
Primary outcome
immune response
Time frame: 1 day
the level of SII
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Aug 2024.
- referenceLink provided by the sponsor.
- referenceLink provided by the sponsor.
- referenceLink provided by the sponsor.
- referenceLink provided by the sponsor.
- Individual participant dataSharing planned: No
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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.
Serkan Sari, Prof study chair
Basaksehir Cith Hospital, Istanbul, Turkey
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Colorectal Cancer and Colorectal Adenocarcinoma, run by Başakşehir Çam & Sakura City Hospital at 1 site in Turkey (Türkiye).
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 4 inclusion and 3 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 15 Aug 2024. 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 Turkey (Türkiye). 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?
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?
immune response (time frame: 1 day). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 15 Aug 2024.