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| Name | Class |
|---|---|
| Sahlgrenska University Hospital | OTHER |
| Skane University Hospital | OTHER |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
| |
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Single-stapled colorectal anastomosis | Procedure | 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. |
| Measure | Description | Time 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 |
| Measure | Description | Time 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 |
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Inclusion Criteria:
Exclusion Criteria:
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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.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Oskar Grahn, MD, PhD | Contact | +46907850000 | oskar.grahn@umu.se |
| Name | Affiliation | Role |
|---|---|---|
| Oskar Grahn, MD, PhD | Umea University / Region Vasterbotten | Principal Investigator |
| Martin Rutegård, MD, PhD | Ostra Sahlgrenska University Hospital, Gothenburg, Sweden | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Östra Sahlgrenska University Hospital | Recruiting | Gothenburg | Sweden |
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| ID | Term |
|---|---|
| D015179 | Colorectal Neoplasms |
| D057868 | Anastomotic Leak |
| ID | Term |
|---|---|
| D007414 | Intestinal Neoplasms |
| D005770 | Gastrointestinal Neoplasms |
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
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|
| Double-stapled colorectal anastomosis | Procedure | 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. |
|
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 |
| Sunderby Hospital | Recruiting | Luleå | Sweden |
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| Skåne University Hospital | Recruiting | Malmö | Sweden |
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| Surgical Centre, Umeå University Hospital | Recruiting | Umeå | Sweden |
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| Uppsala University Hospital | Recruiting | Uppsala | Sweden |
|
| D009369 | Neoplasms |
| D004066 | Digestive System Diseases |
| D005767 | Gastrointestinal Diseases |
| D003108 | Colonic Diseases |
| D007410 | Intestinal Diseases |
| D012002 | Rectal Diseases |
| D011183 | Postoperative Complications |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |