Ignite Creation Date:
2026-03-26 @ 3:18 PM
Ignite Modification Date:
2026-04-01 @ 6:31 PM
Study NCT ID:
NCT07417358
Status:
RECRUITING
Last Update Posted:
2026-02-18
First Post:
2026-01-27
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Single-Stapled Technique for Colorectal Anastomosis
Sponsor:
Umeå University
Organization:
Study Overview
Official Title:
Single-Stapled Technique for Colorectal Anastomosis After Left-Sided Colectomy, Sigmoid Resection or Partial Mesorectal Excision: A Multicentre Prospective Observational Cohort Study
Status:
RECRUITING
Status Verified Date:
2026-02
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
SST
Brief Summary:
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.
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.
Detailed Description:
None
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: