Circular Staplers and Anastomotic Leak After Colorectal Surgery

Официальное название

Prospective Evaluation of the Impact of New Circular Stapler Technology in Colorectal Anastomosis: the PROTECT Study

Обзор

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.

Вмешательства

• Устройство Two-row 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.
• Устройство Three-row circular stapler
  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.
• Устройство Powered circular stapler
  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.

Первичные конечные точки

• Anastomotic leakage [Срок оценки: From the date of surgery until the first occurrence of anastomotic leakage, assessed up to 30 days after surgery]

Вторичные конечные точки (3)

• Postoperative complications [Срок оценки: From the date of surgery until the first occurrence of any postoperative complications, assessed up to 30 days after surgery]
• Reintervention rate [Срок оценки: From the date of surgery until the first reintervention, assessed up to 30 days after index surgery]
• Postoperative length of stay [Срок оценки: From date of surgery until the date of hospital discharge, average 1 week]

Критерии участия

Критерии включения

• 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).

Критерии исключения

• 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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Модель наблюдения

Когортное

Центры проведения

Список центров уточняется — проверьте первичный протокол.

Идентификаторы

NCT: NCT07643857 · PROTECT study

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

Открыть это исследование на ClinicalTrials.gov ↗