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Clinical Trial NCT07417358 (SST) for Colorectal Cancer, Colorectal Anastomosis, Anastomotic Leakage, Diverticular Disease of Left Side of Colon is recruiting. See the Trial Radar Card View and AI discovery tools for all the details. Or ask anything here.
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Single-Stapled Technique for Colorectal Anastomosis (SST) 500 Randomized International Observational

Recruiting
Clinical Trial NCT07417358 (SST) is an observational study for Colorectal Cancer, Colorectal Anastomosis, Anastomotic Leakage, Diverticular Disease of Left Side of Colon that is recruiting. It started on 7 January 2026 with plans to enroll 500 participants. Led by Umeå University, it is expected to complete by 30 June 2029. The latest data from ClinicalTrials.gov was last updated on 18 February 2026.
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 anasto...

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Official Title

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

Conditions
Colorectal CancerColorectal AnastomosisAnastomotic LeakageDiverticular Disease of Left Side of Colon
Other Study IDs
  • SST
  • SST-MC-2025
NCT ID Number
NCT07417358
Start Date (Actual)
2026-01-07
Last Update Posted
2026-02-18
Completion Date (Estimated)
2029-06-30
Enrollment (Estimated)
500
Study Type
Observational
Status
Recruiting
Keywords
Single-stapled anastomosis
Colorectal anastomosis
Anastomotic leakage
Colorectal surgery
Left-sided colon resection
Partial mesorectal excision
Arms / Interventions
Participant Group/ArmIntervention/Treatment
Prospective single-stapled technique cohort
Adult patients undergoing planned left-sided colorectal resection with colorectal anastomosis (including sigmoid resection, left hemicolectomy, or partial mesorectal excision) in whom the anastomosis is constructed using the single-stapled technique (SST) as part of routine clinical practice. Patients are included prospectively and followed for postoperative complications, including anastomotic leakage within 90 days...Show More
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.
Retrospective double-stapled technique cohort
A retrospective cohort of adult patients who previously underwent planned left-sided colorectal resection with colorectal anastomosis using the conventional double-stapled technique (DST) during the years 2023-2025. Patients are identified through medical record review at participating centers using the same inclusion criteria as the prospective cohort, and outcome data are collected retrospectively for comparison.
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.
Primary Outcome Measures
Outcome MeasureMeasure DescriptionTime Frame
Anastomotic leakage (ISREC), within 90 days
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.
Within 90 days after surgery
Secondary Outcome Measures
Outcome MeasureMeasure DescriptionTime Frame
Feasibility of the single-stapled technique (SST)
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.
During surgery
Completeness of stapled anastomotic rings
Binary intraoperative assessment of stapled anastomotic ring completeness, recorded as complete or incomplete.
During surgery
Intraoperative air leak test result
Binary intraoperative air leak test result, recorded as leak detected or no leak detected.
During surgery
Duration of surgery
Total operative time measured in minutes from skin incision to skin closure.
During surgery
Length of postoperative hospital stay
Length of hospital stay measured in days from the date of surgery to the date of discharge.
Within 90 days of primary surgery
Hospital readmission rate
Proportion of patients readmitted to hospital within 90 days after surgery, with causes recorded descriptively.
Within 90 days after surgery
Postoperative complications (Clavien-Dindo classification)
Highest Clavien-Dindo grade within 90 days after surgery (Grade I-V), where higher grade indicates more severe complications.
Within 90 days after surgery
All-cause mortality
Proportion of patients who die from any cause within 90 days after surgery.
Within 90 days after surgery
Recurrence-free survival
Recurrence-free survival defined as time from surgery to the first occurrence of local recurrence, distant recurrence, or death from any cause.
Upto three years after primary surgery
Stoma-free survival
Stoma-free survival defined as survival without a diverting or permanent stoma following left-sided colorectal surgery.
At one and three years after surgery
Participation Assistant
Eligibility Criteria

Eligible Ages
Adult, Older Adult
Minimum Age
18 Years
Eligible Sexes
All
  • 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.

  • 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.
Umeå University logoUmeå University
  • Sahlgrenska University Hospital logoSahlgrenska University Hospital
  • Skane University Hospital logoSkane University Hospital
Study Responsible Party
Oskar Grahn, Principal Investigator, MD, PhD, Umeå University
Study Central Contact
Contact: Oskar Grahn, MD, PhD, +46907850000, [email protected]
5 Study Locations in 1 Countries
Östra Sahlgrenska University Hospital, Gothenburg, Sweden
Martin Rutegård, MD, PhD, Contact, +4631 342 10 00, [email protected]
Recruiting
Sunderby Hospital, Luleå, Sweden
Christoffer Odensten, MD, PhD, Contact, +46920 28 20 00, [email protected]
Recruiting
Skåne University Hospital, Malmo, Sweden
Erik Agger, MD, PhD, Contact, +4640 33 10 00
Recruiting
Surgical Centre, Umeå University Hospital, Umeå, Sweden
Oskar Grahn, MD, PhD, Contact, +46907850000, [email protected]
Recruiting
Uppsala University Hospital, Uppsala, Sweden
Malin Enblad, MD, PhD, Contact, +4618 611 00 00, [email protected]
Recruiting