Circular Staplers and Anastomotic Leak After Colorectal Surgery (PROTECT)
10. juni 2026 opdateret af: Azienda Ospedaliera Bolognini di Seriate Bergamo
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.
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.
Studieoversigt
Status
Ikke rekrutterer endnu
Betingelser
Intervention / Behandling
Undersøgelsestype
Observationel
Tilmelding (Anslået)
597
Kontakter og lokationer
Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.
Studiekontakt
- Navn: Stefano Agnesi, MD
- Telefonnummer: +390353063612
- E-mail: stefano.agnesi@asst-bergamoest.it
Deltagelseskriterier
Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.
Berettigelseskriterier
Aldre berettiget til at studere
- Voksen
- Ældre voksen
Tager imod sunde frivillige
Ingen
Prøveudtagningsmetode
Ikke-sandsynlighedsprøve
Studiebefolkning
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.
Beskrivelse
Inclusion Criteria:
- 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).
Exclusion Criteria:
- 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
Studieplan
Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
Kohorter og interventioner
Gruppe / kohorte |
Intervention / Behandling |
|---|---|
|
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).
|
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 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 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.
|
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Tidsramme |
|---|---|
|
Anastomotic leakage
Tidsramme: From the date of surgery until the first occurrence of anastomotic leakage, assessed up to 30 days after surgery
|
From the date of surgery until the first occurrence of anastomotic leakage, assessed up to 30 days after surgery
|
Sekundære resultatmål
Resultatmål |
Tidsramme |
|---|---|
|
Postoperative complications
Tidsramme: From the date of surgery until the first occurrence of any postoperative complications, assessed up to 30 days after surgery
|
From the date of surgery until the first occurrence of any postoperative complications, assessed up to 30 days after surgery
|
|
Reintervention rate
Tidsramme: From the date of surgery until the first reintervention, assessed up to 30 days after index surgery
|
From the date of surgery until the first reintervention, assessed up to 30 days after index surgery
|
|
Postoperative length of stay
Tidsramme: From date of surgery until the date of hospital discharge, average 1 week
|
From date of surgery until the date of hospital discharge, average 1 week
|
Samarbejdspartnere og efterforskere
Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.
Datoer for undersøgelser
Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.
Studer store datoer
Studiestart (Anslået)
1. september 2026
Primær færdiggørelse (Anslået)
1. september 2027
Studieafslutning (Anslået)
1. september 2027
Datoer for studieregistrering
Først indsendt
2. juni 2026
Først indsendt, der opfyldte QC-kriterier
10. juni 2026
Først opslået (Faktiske)
12. juni 2026
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
12. juni 2026
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
10. juni 2026
Sidst verificeret
1. juni 2026
Mere information
Begreber relateret til denne undersøgelse
Nøgleord
Andre undersøgelses-id-numre
- PROTECT study
Plan for individuelle deltagerdata (IPD)
Planlægger du at dele individuelle deltagerdata (IPD)?
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