NCT Number: NCT07417358
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.
Interested in participating?
Request Info18 year and older
All sexes
Observational
Östra Sahlgrenska University Hospital, Gothenburg, Sweden
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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.
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.
Time frame: Within 90 days after surgery
Anastomotic leakage following colorectal anastomosis, defined according to the International Study Group of Rectal Cancer (ISREC). Anastomotic leakage is recorded as a binary outcome (yes/no). Severity grading (ISREC Grade A, B, or C) will be reported descriptively as part of the same outcome.
Time frame: During surgery
Feasibility defined as the proportion of intended SST cases in which the colorectal anastomosis could be completed using the single-stapled technique as planned, without intraoperative conversion to another anastomotic technique.
Time frame: During surgery
Binary intraoperative assessment of stapled anastomotic ring completeness, recorded as complete or incomplete.
Time frame: During surgery
Binary intraoperative air leak test result, recorded as leak detected or no leak detected.
Time frame: During surgery
Total operative time measured in minutes from skin incision to skin closure.
Time frame: Within 90 days of primary surgery
Length of hospital stay measured in days from the date of surgery to the date of discharge.
Time frame: Within 90 days after surgery
Proportion of patients readmitted to hospital within 90 days after surgery, with causes recorded descriptively.
Time frame: Within 90 days after surgery
Highest Clavien-Dindo grade within 90 days after surgery (Grade I-V), where higher grade indicates more severe complications.
Time frame: Within 90 days after surgery
Proportion of patients who die from any cause within 90 days after surgery.
Time frame: Upto three years after primary surgery
Recurrence-free survival defined as time from surgery to the first occurrence of local recurrence, distant recurrence, or death from any cause.
Time frame: At one and three years after surgery
Stoma-free survival defined as survival without a diverting or permanent stoma following left-sided colorectal surgery.
Contact information is provided by the study sponsor or research team.
Umeå University
Other
Single-Stapled Technique for Colorectal Anastomosis After Left-Sided Colectomy, Sigmoid Resection or Partial Mesorectal Excision: A Multicentre Prospective Observational Cohort Study
Acronym: SST
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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