Single-Stapled Technique for Colorectal Anastomosis

Официальное название

Single-Stapled Technique for Colorectal Anastomosis After Left-Sided Colectomy, Sigmoid Resection or Partial Mesorectal Excision: A Multicentre Prospective Observational Cohort Study

Обзор

The goal of this observational multicenter study is to evaluate the safety and feasibility of a single-stapled technique (SST) for colorectal anastomosis and to explore whether this technique is associated with a reduced rate of anastomotic leakage compared with the conventional double-stapled technique (DST). The study includes adult patients undergoing planned left-sided colorectal resection with colorectal anastomosis, including sigmoid resection, left hemicolectomy, or partial mesorectal excision (PME), for benign or malignant disease. The main questions it aims to answer are: What is the rate of anastomotic leakage within 90 days after surgery in patients operated with the single-stapled technique? Is the single-stapled technique feasible and safe across different surgical approaches (open, laparoscopic, and robot-assisted surgery) in a multicenter setting? Furthermore, outcomes after single-stapled anastomosis will be compared with a retrospective cohort of patients operated with the conventional double-stapled technique to explore potential differences in anastomotic leakage rates and postoperative complications. Participants will receive standard surgical care as determined by the treating surgical team. Patients included in the prospective part of the study will undergo colorectal anastomosis using the single-stapled technique as part of routine clinical practice. Data on perioperative variables, postoperative complications (including anastomotic leakage graded according to international consensus definitions), and follow-up outcomes will be collected prospectively using an electronic case report form (eCRF). A retrospective cohort from the same participating centers will be identified through medical record review using identical inclusion criteria. The results of this study are intended to provide robust multicenter data on the safety and clinical outcomes of the single-stapled technique and to serve as the basis for planning a future randomized controlled multicenter trial.

Вмешательства

• Процедура Single-stapled colorectal anastomosis
  Construction of a colorectal anastomosis using a single-stapled technique, where the rectal staple line is excised and a purse-string suture is placed on the rectal stump and tied around the tip of a circular stapler, before completion of the anastomosis. The procedure is performed as part of routine clinical practice during planned left-sided colorectal resection.
• Процедура Double-stapled colorectal anastomosis
  Construction of a colorectal anastomosis using the conventional double-stapled technique, where the rectal stump is closed with a linear stapler and the anastomosis is completed using a circular stapler and without excision of the rectal staple line. The procedure is performed as part of standard surgical practice.

Первичные конечные точки

• Anastomotic leakage (ISREC), within 90 days [Срок оценки: Within 90 days after surgery]

Вторичные конечные точки (10)

• Feasibility of the single-stapled technique (SST) [Срок оценки: During surgery]
• Completeness of stapled anastomotic rings [Срок оценки: During surgery]
• Intraoperative air leak test result [Срок оценки: During surgery]
• Duration of surgery [Срок оценки: During surgery]
• Length of postoperative hospital stay [Срок оценки: Within 90 days of primary surgery]
• Hospital readmission rate [Срок оценки: Within 90 days after surgery]
• Postoperative complications (Clavien-Dindo classification) [Срок оценки: Within 90 days after surgery]
• All-cause mortality [Срок оценки: Within 90 days after surgery]
• Recurrence-free survival [Срок оценки: Upto three years after primary surgery]
• Stoma-free survival [Срок оценки: At one and three years after surgery]

Критерии участия

Критерии включения

• Age ≥ 18 years.
• Planned (elective) left-sided colorectal resection with creation of a colorectal anastomosis, including: Left hemicolectomy, and/or Sigmoid resection, and/or Partial mesorectal excision (PME).
• Benign or malignant indication.
• Prospective cohort: Ability to provide written informed consent.
• Retrospective cohort: Eligible patients operated during 2023-2025 at participating centers, identified through medical record review, meeting the same surgical inclusion criteria.

Критерии исключения

• Total mesorectal excision (TME) (e.g., low rectal cancer surgery requiring TME).
• Non-left-sided colorectal resections (e.g., right-sided colectomy) or procedures outside the study-defined operations.
• Surgery not involving a colorectal anastomosis (e.g., end colostomy/Hartmann's procedure without anastomosis).
• Emergency/urgent colorectal resection (non-elective surgery).
• Prospective cohort: Inability to provide 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

Швеция · 5 центров

• Östra Sahlgrenska University Hospital — Gothenburg
• Sunderby Hospital — Luleå
• Skåne University Hospital — Malmö
• Surgical Centre, Umeå University Hospital — Umeå
• Uppsala University Hospital — Uppsala

Идентификаторы

NCT: NCT07417358 · SST-MC-2025

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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