Colorectal Cancer Postoperative ComplicationsPROTECTNCT07643857
Circular Staplers and Anastomotic Leak After Colorectal Surgery
An observational study of Colorectal Cancer Postoperative Complications, run by Azienda Ospedaliera Bolognini di Seriate Bergamo.
Trial summary
The goal of this observational study is to evaluate whether different circular stapling devices influence the success of the surgical connection between the bowel ends after colorectal cancer surgery in patients undergoing colorectal resection using different stapling devices. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Colorectal Cancer Postoperative Complications
- What is being tested?
- Two-row circular stapler, Three-row circular stapler and Powered circular stapler
- Type of treatment
- Medical device
- How many people
- 597 participants
- Where
- No sites listed yet
- Study dates
- Sep 2026to Sep 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: The study population consists of patients undergoing elective colorectal resection with primary colorectal anastomosis for colorectal cancer at participating centers. Participants will be recruited from multiple italian and international hospitals involved in this multicenter observational study.
Who may be able to join
- Adult patients (18 years or older)
- Patients undergoing elective surgery, either open or minimally invasive (laparoscopic or robotic), for anterior rectal resection, sigmoid resection, or left hemicolectomy for colorectal cancer with concomitant colorectal anastomosis (Knight-Griffen technique) using one of the circular stapler types under investigation (two-row CS, three-row CS, PCS).
Who cannot join
- Patients undergoing emergency surgery
- Patients undergoing additional surgical procedures during the same operation (e.g., cholecystectomy, liver resection, etc.)
- Patients with documented metastases at preoperative staging (cM+)
- Patients under 18 years of age
- Lack of informed consent
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Prospective Evaluation of the Impact of New Circular Stapler Technology in Colorectal Anastomosis: the PROTECT Study
The goal of this observational study is to evaluate whether different circular stapling devices influence the success of the surgical connection between the bowel ends after colorectal cancer surgery in patients undergoing colorectal resection using different stapling devices.
The main question this study aims to answer is whether different circular stapling devices affect the risk of a leak developing at the site where the bowel is reconnected after colorectal cancer surgery.
Read more
Researchers will compare three types of circular stapling devices commonly used in clinical practice (two-row, three-row, and powered circular staplers) to determine whether they are associated with different risks of leakage at the site where the bowel is reconnected after colorectal cancer surgery.
Participants will receive standard medical care. Taking part in this study will not affect their treatment, and no additional procedures, tests, or visits are required as part of the study.
- Being tested
- Two-row circular stapler, Three-row circular stapler, Powered circular stapler
- Keywords
- Colorectal anastomosis, circular stapler, powered circular stapler, three-rwo circular stapler, two-row circular stapler, Tristaple
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Two-row circular staplerDevice
Two-row circular stapler: circular stapling device creating a colorectal anastomosis using two concentric rows of staples. The device is used according to routine clinical practice during colorectal resection with primary anastomosis.
Three-row circular staplerDevice
Three-row circular stapler: circular stapling device creating a colorectal anastomosis using three concentric rows of staples with graduated staple heights designed to optimize tissue compression and sealing. The device is used according to routine clinical practice during colorectal resection with primary anastomosis.
Powered circular staplerDevice
Powered circular stapler: electrically powered circular stapling device used to create a colorectal anastomosis. The powered mechanism is designed to standardize tissue compression and stapler firing while reducing operator-dependent variability. The device is used according to routine clinical practice during colorectal resection with primary anastomosis.
| Study group | Role | What they receive |
|---|---|---|
| Patients undergoing colorectal cancer surgery with primary anastomosis | Patients undergoing elective surgery for anterior rectal resection, sigmoid resection, or left hemicolectomy for colorectal cancer with concomitant colorectal anastomosis (Knight-Griffen technique) using one of the circular stapler types under investigation (two-row circular stapler, three-row circular stapler, powered circular stapler). Receives: Device: Two-row circular stapler; Device: Three-row circular stapler; Device: Powered circular stapler |
What is being measured
The primary outcome is the main question the study is designed to answer.
Anastomotic leakage
Measured: From the date of surgery until the first occurrence of anastomotic leakage, assessed up to 30 days after surgery
Secondary outcomes (3)
Postoperative complications
Measured: From the date of surgery until the first occurrence of any postoperative complications, assessed up to 30 days after surgery
Reintervention rate
Measured: From the date of surgery until the first reintervention, assessed up to 30 days after index surgery
Postoperative length of stay
Measured: From date of surgery until the date of hospital discharge, average 1 week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jun 2026
- Study startSep 2026 (estimated)
- Primary completionSep 2027 (estimated)
- Study completionSep 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Colorectal Cancer Postoperative ComplicationsStudies 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
- 597 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Azienda Ospedaliera Bolognini di Seriate Bergamo
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07643857
- Sponsor's protocol ID
- PROTECT study
- Acronym
- PROTECT
- Status last verified
- Jun 2026
- First submitted
- 2 Jun 2026
- Last updated
- 12 Jun 2026
- Results posted
- 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 12 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective Evaluation of the Impact of New Circular Stapler Technology in Colorectal Anastomosis: the PROTECT Study
- ClinicalTrials.gov ID
- NCT07643857
- Acronym / sponsor ID
- PROTECT / PROTECT study
- Keywords
- Colorectal anastomosis, circular stapler, powered circular stapler, three-rwo circular stapler, two-row circular stapler, Tristaple
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 597 participants (estimated)
- Lead sponsor
- Azienda Ospedaliera Bolognini di Seriate BergamoUniversity, hospital or other
- Study start
- Sep 2026 (estimated)
- Primary completion
- Sep 2027 (estimated)
- Study completion
- Sep 2027 (estimated)
- First posted
- 12 Jun 2026 (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 goal of this observational study is to evaluate whether different circular stapling devices influence the success of the surgical connection between the bowel ends after colorectal cancer surgery in patients undergoing colorectal resection using different stapling devices.
The main question this study aims to answer is whether different circular stapling devices affect the risk of a leak developing at the site where the bowel is reconnected after colorectal cancer surgery.
Researchers will compare three types of circular stapling devices commonly used in clinical practice (two-row, three-row, and powered circular staplers) to determine whether they are associated with different risks of leakage at the site where the bowel is reconnected after colorectal cancer surgery.
Participants will receive standard medical care. Taking part in this study will not affect their treatment, and no additional procedures, tests, or visits are required as part of the study.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients undergoing colorectal cancer surgery with primary anastomosis | – | Device: Two-row circular stapler, Device: Three-row circular stapler, Device: Powered circular staplerPatients undergoing elective surgery for anterior rectal resection, sigmoid resection, or left hemicolectomy for colorectal cancer with concomitant colorectal anastomosis (Knight-Griffen technique) using one of the circular stapler types under investigation (two-row circular stapler, three-row circular stapler, powered circular stapler). |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- The study population consists of patients undergoing elective colorectal resection with primary colorectal anastomosis for colorectal cancer at participating centers. Participants will be recruited from multiple italian and international hospitals involved in this multicenter observational study.
Key inclusion criteria (2 listed)
- Adult patients (18 years or older)
- Patients undergoing elective surgery, either open or minimally invasive (laparoscopic or robotic), for anterior rectal resection, sigmoid resection, or left hemicolectomy for colorectal cancer with concomitant colorectal anastomosis (Knight-Griffen technique) using one of the circular stapler types under investigation (two-row CS, three-row CS, PCS).
Key exclusion criteria (5 listed)
- Patients undergoing emergency surgery
- Patients undergoing additional surgical procedures during the same operation (e.g., cholecystectomy, liver resection, etc.)
- Patients with documented metastases at preoperative staging (cM+)
- Patients under 18 years of age
- Lack of informed consent
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 |
|---|---|---|
| Two-row circular staplerTwo-row circular stapler: circular stapling device creating a colorectal anastomosis using two concentric rows of staples. The device is used according to routine clinical practice during colorectal resection with primary anastomosis. | Device | Patients undergoing colorectal cancer surgery with primary anastomosis |
| Three-row circular staplerThree-row circular stapler: circular stapling device creating a colorectal anastomosis using three concentric rows of staples with graduated staple heights designed to optimize tissue compression and sealing. The device is used according to routine clinical practice during colorectal resection with primary anastomosis. | Device | Patients undergoing colorectal cancer surgery with primary anastomosis |
| Powered circular staplerPowered circular stapler: electrically powered circular stapling device used to create a colorectal anastomosis. The powered mechanism is designed to standardize tissue compression and stapler firing while reducing operator-dependent variability. The device is used according to routine clinical practice during colorectal resection with primary anastomosis. | Device | Patients undergoing colorectal cancer surgery with primary anastomosis |
Primary outcome
Anastomotic leakage
Time frame: From the date of surgery until the first occurrence of anastomotic leakage, assessed up to 30 days after surgery
3 secondary outcomes
Postoperative complications
Time frame: From the date of surgery until the first occurrence of any postoperative complications, assessed up to 30 days after surgery
Reintervention rate
Time frame: From the date of surgery until the first reintervention, assessed up to 30 days after index surgery
Postoperative length of stay
Time frame: From date of surgery until the date of hospital discharge, average 1 week
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Jun 2026.
- 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.
Questions about this trial
What is this clinical trial studying?
An observational study of Colorectal Cancer Postoperative Complications, run by Azienda Ospedaliera Bolognini di Seriate Bergamo.
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 2 inclusion and 5 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: opening soon, as of the sponsor's last update on 12 Jun 2026. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Stefano Agnesi, MD (+390353063612, stefano.agnesi@asst-bergamoest.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Anastomotic leakage (time frame: From the date of surgery until the first occurrence of anastomotic leakage, assessed up to 30 days after surgery). 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 12 Jun 2026.