Colorectal CancerSSTNCT07417358
Single-Stapled Technique for Colorectal Anastomosis
An observational study of Colorectal Cancer and Colorectal Anastomosis, run by Umeå University at 5 sites in Sweden.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Colorectal Cancer, Colorectal Anastomosis, Anastomotic Leakage
- What is being tested?
- Single-stapled colorectal anastomosis and Double-stapled colorectal anastomosis
- Type of treatment
- Surgery or procedure
- How many people
- 500 participants
- Where
- 5 sitesSweden
- Study dates
- 7 Jan 2026to 30 Jun 2029
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: The study population consists of adult patients (≥18 years) undergoing planned left-sided colorectal resection with construction of a colorectal anastomosis, including left hemicolectomy, sigmoid resection, or partial mesorectal excision, for benign or malignant indications. Patients are treated as part of routine clinical care at participating centers. The study includes both a retrospective cohort of patients operated during 2023-2025 and a prospective cohort of consecutively included patients undergoing surgery after study initiation. In the prospective cohort, the intent is to perform a single-stapled colorectal anastomosis when technically feasible in all consenting patients.
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
5 sites in 1 country. Contact the study team or a site near you to ask about taking part.
5 sites in 1 country
Sweden5 sites, 5 recruiting
- Recruiting
Östra Sahlgrenska University Hospital
Gothenburg
Martin Rutegård, MD, PhD, +4631 342 10 00, martin.rutegard@vgregion.se
- Recruiting
Sunderby Hospital
Luleå
Christoffer Odensten, MD, PhD, +46920 28 20 00, christoffer.odensten@umu.se
- Recruiting
Skåne University Hospital
Malmö
Erik Agger, MD, PhD, +4640 33 10 00
- Recruiting
Surgical Centre, Umeå University Hospital
Umeå
Oskar Grahn, MD, PhD, +46907850000, oskar.grahn@umu.se
- Recruiting
Uppsala University Hospital
Uppsala
Malin Enblad, MD, PhD, +4618 611 00 00, malin.enblad@uu.se
About this study
Official title: Single-Stapled Technique for Colorectal Anastomosis After Left-Sided Colectomy, Sigmoid Resection or Partial Mesorectal Excision: A Multicentre Prospective Observational Cohort Study
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.
Read more
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.
- Conditions
- Colorectal Cancer, Colorectal Anastomosis, Anastomotic Leakage, Diverticular Disease of Left Side of Colon
- Being tested
- Single-stapled colorectal anastomosis, Double-stapled colorectal anastomosis
- Keywords
- Single-stapled anastomosis, Colorectal anastomosis, Anastomotic leakage, Colorectal surgery, Left-sided colon resection, Partial mesorectal excision
- Medical subject headings
- Colorectal Neoplasms, Anastomotic Leak
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Single-stapled colorectal anastomosisProcedure or surgery
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.
Double-stapled colorectal anastomosisProcedure or surgery
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.
| Study group | Role | What they receive |
|---|---|---|
| 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, as well as longer-term outcomes. Receives: Procedure: Single-stapled colorectal anastomosis | |
| 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. Receives: Procedure: Double-stapled colorectal anastomosis |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Within 90 days after surgery
Secondary outcomes (10)
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.
Measured: During surgery
Completeness of stapled anastomotic rings
Binary intraoperative assessment of stapled anastomotic ring completeness, recorded as complete or incomplete.
Measured: During surgery
Intraoperative air leak test result
Binary intraoperative air leak test result, recorded as leak detected or no leak detected.
Measured: During surgery
Duration of surgery
Total operative time measured in minutes from skin incision to skin closure.
Measured: During surgery
Length of postoperative hospital stay
Length of hospital stay measured in days from the date of surgery to the date of discharge.
Measured: Within 90 days of primary surgery
Hospital readmission rate
Proportion of patients readmitted to hospital within 90 days after surgery, with causes recorded descriptively.
Measured: 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.
Measured: Within 90 days after surgery
All-cause mortality
Proportion of patients who die from any cause within 90 days after surgery.
Measured: 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.
Measured: 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.
Measured: At one and three years after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Feb 2026
- Study start7 Jan 2026
- Primary completion30 Jun 2028 (estimated)
- Study completion30 Jun 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Colorectal CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 500 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Umeå University
- Sponsor type
- University, hospital or other
- Collaborators
- Sahlgrenska University Hospital, Skane University Hospital
- Responsible party
- Principal investigator, Oskar Grahn, Umeå University
- Investigators
- Oskar Grahn, MD, PhD, Principal investigator, Umea University / Region VasterbottenMartin Rutegård, MD, PhD, Principal investigator, Ostra Sahlgrenska University Hospital, Gothenburg, Sweden
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07417358
- Sponsor's protocol ID
- SST-MC-2025
- Acronym
- SST
- Status last verified
- Feb 2026
- First submitted
- 27 Jan 2026
- Last updated
- 18 Feb 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Single-Stapled Technique for Colorectal Anastomosis After Left-Sided Colectomy, Sigmoid Resection or Partial Mesorectal Excision: A Multicentre Prospective Observational Cohort Study
- ClinicalTrials.gov ID
- NCT07417358
- Acronym / sponsor ID
- SST / SST-MC-2025
- Conditions
- Colorectal Cancer, Colorectal Anastomosis, Anastomotic Leakage, Diverticular Disease of Left Side of Colon
- Keywords
- Single-stapled anastomosis, Colorectal anastomosis, Anastomotic leakage, Colorectal surgery, Left-sided colon resection, Partial mesorectal excision
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 500 participants (estimated)
- Lead sponsor
- Umeå UniversityUniversity, hospital or other
- Collaborators
- Sahlgrenska University Hospital, Skane University Hospital
- Study start
- 7 Jan 2026 (actual)
- Primary completion
- 30 Jun 2028 (estimated)
- Study completion
- 30 Jun 2029 (estimated)
- First posted
- 18 Feb 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Prospective single-stapled technique cohort | – | Procedure: Single-stapled colorectal anastomosisAdult 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, as well as longer-term outcomes. |
| Retrospective double-stapled technique cohort | – | Procedure: Double-stapled colorectal anastomosisA 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- The study population consists of adult patients (≥18 years) undergoing planned left-sided colorectal resection with construction of a colorectal anastomosis, including left hemicolectomy, sigmoid resection, or partial mesorectal excision, for benign or malignant indications. Patients are treated as part of routine clinical care at participating centers. The study includes both a retrospective cohort of patients operated during 2023-2025 and a prospective cohort of consecutively included patients undergoing surgery after study initiation. In the prospective cohort, the intent is to perform a single-stapled colorectal anastomosis when technically feasible in all consenting patients.
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Single-stapled colorectal anastomosisConstruction 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. | Procedure or surgery | Prospective single-stapled technique cohort |
| Double-stapled colorectal anastomosisConstruction 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. | Procedure or surgery | Retrospective double-stapled technique cohort |
Primary outcome
Anastomotic leakage (ISREC), within 90 days
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.
10 secondary outcomes
Feasibility of the single-stapled technique (SST)
Time frame: During surgery
Completeness of stapled anastomotic rings
Time frame: During surgery
Intraoperative air leak test result
Time frame: During surgery
Duration of surgery
Time frame: During surgery
Length of postoperative hospital stay
Time frame: Within 90 days of primary surgery
Hospital readmission rate
Time frame: Within 90 days after surgery
Postoperative complications (Clavien-Dindo classification)
Time frame: Within 90 days after surgery
All-cause mortality
Time frame: Within 90 days after surgery
Recurrence-free survival
Time frame: Upto three years after primary surgery
Stoma-free survival
Time frame: At one and three years after surgery
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Feb 2026.
- Individual participant dataSharing planned: No
Related trials for Colorectal Cancer
Not yet recruitingPhase 1
Hepatic Artery Infusion of Carfilzomib in Participants With Liver Metastatic Disease Previously Treated With Hepatic Artery Infusion Pump Therapy
Colorectal Neoplasms, Neoplasms
RecruitingObservational study
Obtaining Solid Tumor Tissue From People Having Biopsy or Surgery for Certain Types of Cancer
Colorectal Neoplasms, Gastric Neoplasms
Not yet recruitingPhase 2
Phase II Clinical Study of RC148 (ABBV-1480) in Combination With Telisotuzumab Adizutecan (With or Without Chemotherapy) for Unresectable Colorectal Cancer
Patients With Unresectable Colorectal Cancer Requiring First-Line or Second-Line Therapy
RecruitingPhase 1
A Study of LY4257496 in Participants With Cancer (OMNIRAY)
Breast Neoplasms, Colorectal Neoplasms
Active, not recruitingPhase 3
Nivolumab After Combined Modality Therapy in Treating Patients With High Risk Stage II-IIIB Anal Cancer
Anal Basaloid Carcinoma, Anal Canal Cloacogenic Carcinoma
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Oskar Grahn, MD, PhD principal investigator
Umea University / Region Vasterbotten
Martin Rutegård, MD, PhD principal investigator
Ostra Sahlgrenska University Hospital, Gothenburg, Sweden
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Colorectal Cancer and Colorectal Anastomosis, run by Umeå University at 5 sites in Sweden.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 18 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in Sweden. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Oskar Grahn, MD, PhD (+46907850000, oskar.grahn@umu.se), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Anastomotic leakage (ISREC), within 90 days (time frame: Within 90 days after surgery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Feb 2026.