Circular Staplers and Anastomotic Leak After Colorectal Surgery (PROTECT)
10 juni 2026 uppdaterad av: 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.
Studieöversikt
Status
Har inte rekryterat ännu
Intervention / Behandling
Studietyp
Observationell
Inskrivning (Beräknad)
597
Kontakter och platser
Det här avsnittet innehåller kontaktuppgifter för dem som genomför studien och information om var denna studie genomförs.
Studiekontakt
- Namn: Stefano Agnesi, MD
- Telefonnummer: +390353063612
- E-post: stefano.agnesi@asst-bergamoest.it
Deltagandekriterier
Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.
Urvalskriterier
Åldrar som är berättigade till studier
- Vuxen
- Äldre vuxen
Tar emot friska volontärer
Nej
Testmetod
Icke-sannolikhetsprov
Studera befolkning
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.
Beskrivning
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
Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.
Hur är studien utformad?
Designdetaljer
Kohorter och interventioner
Grupp / Kohort |
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.
|
Vad mäter studien?
Primära resultatmått
Resultatmått |
Tidsram |
|---|---|
|
Anastomotic leakage
Tidsram: 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
|
Sekundära resultatmått
Resultatmått |
Tidsram |
|---|---|
|
Postoperative complications
Tidsram: 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
Tidsram: 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
Tidsram: 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
|
Samarbetspartners och utredare
Det är här du hittar personer och organisationer som är involverade i denna studie.
Studieavstämningsdatum
Dessa datum spårar framstegen för inlämningar av studieposter och sammanfattande resultat till ClinicalTrials.gov. Studieposter och rapporterade resultat granskas av National Library of Medicine (NLM) för att säkerställa att de uppfyller specifika kvalitetskontrollstandarder innan de publiceras på den offentliga webbplatsen.
Studera stora datum
Studiestart (Beräknad)
1 september 2026
Primärt slutförande (Beräknad)
1 september 2027
Avslutad studie (Beräknad)
1 september 2027
Studieregistreringsdatum
Först inskickad
2 juni 2026
Först inskickad som uppfyllde QC-kriterierna
10 juni 2026
Första postat (Faktisk)
12 juni 2026
Uppdateringar av studier
Senaste uppdatering publicerad (Faktisk)
12 juni 2026
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
10 juni 2026
Senast verifierad
1 juni 2026
Mer information
Termer relaterade till denna studie
Nyckelord
Andra studie-ID-nummer
- PROTECT study
Plan för individuella deltagardata (IPD)
Planerar du att dela individuella deltagardata (IPD)?
NEJ
Läkemedels- och apparatinformation, studiedokument
Studerar en amerikansk FDA-reglerad läkemedelsprodukt
Nej
Studerar en amerikansk FDA-reglerad produktprodukt
Nej
Denna information hämtades direkt från webbplatsen clinicaltrials.gov utan några ändringar. Om du har några önskemål om att ändra, ta bort eller uppdatera dina studieuppgifter, vänligen kontakta register@clinicaltrials.gov. Så snart en ändring har implementerats på clinicaltrials.gov, kommer denna att uppdateras automatiskt även på vår webbplats .