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:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2026-03-25'}, 'conditionBrowseModule': {'meshes': [{'id': 'D015179', 'term': 'Colorectal Neoplasms'}, {'id': 'D057868', 'term': 'Anastomotic Leak'}], 'ancestors': [{'id': 'D007414', 'term': 'Intestinal Neoplasms'}, {'id': 'D005770', 'term': 'Gastrointestinal Neoplasms'}, {'id': 'D004067', 'term': 'Digestive System Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}, {'id': 'D005767', 'term': 'Gastrointestinal Diseases'}, {'id': 'D003108', 'term': 'Colonic Diseases'}, {'id': 'D007410', 'term': 'Intestinal Diseases'}, {'id': 'D012002', 'term': 'Rectal Diseases'}, {'id': 'D011183', 'term': 'Postoperative Complications'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 500}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2026-01-07', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2026-02', 'completionDateStruct': {'date': '2029-06-30', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2026-02-10', 'studyFirstSubmitDate': '2026-01-27', 'studyFirstSubmitQcDate': '2026-02-10', 'lastUpdatePostDateStruct': {'date': '2026-02-18', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2026-02-18', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2028-06-30', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Anastomotic leakage (ISREC), within 90 days', 'timeFrame': 'Within 90 days after surgery', 'description': '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.'}], 'secondaryOutcomes': [{'measure': 'Feasibility of the single-stapled technique (SST)', 'timeFrame': 'During surgery', 'description': '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.'}, {'measure': 'Completeness of stapled anastomotic rings', 'timeFrame': 'During surgery', 'description': 'Binary intraoperative assessment of stapled anastomotic ring completeness, recorded as complete or incomplete.'}, {'measure': 'Intraoperative air leak test result', 'timeFrame': 'During surgery', 'description': 'Binary intraoperative air leak test result, recorded as leak detected or no leak detected.'}, {'measure': 'Duration of surgery', 'timeFrame': 'During surgery', 'description': 'Total operative time measured in minutes from skin incision to skin closure.'}, {'measure': 'Length of postoperative hospital stay', 'timeFrame': 'Within 90 days of primary surgery', 'description': 'Length of hospital stay measured in days from the date of surgery to the date of discharge.'}, {'measure': 'Hospital readmission rate', 'timeFrame': 'Within 90 days after surgery', 'description': 'Proportion of patients readmitted to hospital within 90 days after surgery, with causes recorded descriptively.'}, {'measure': 'Postoperative complications (Clavien-Dindo classification)', 'timeFrame': 'Within 90 days after surgery', 'description': 'Highest Clavien-Dindo grade within 90 days after surgery (Grade I-V), where higher grade indicates more severe complications.'}, {'measure': 'All-cause mortality', 'timeFrame': 'Within 90 days after surgery', 'description': 'Proportion of patients who die from any cause within 90 days after surgery.'}, {'measure': 'Recurrence-free survival', 'timeFrame': 'Upto three years after primary surgery', 'description': 'Recurrence-free survival defined as time from surgery to the first occurrence of local recurrence, distant recurrence, or death from any cause.'}, {'measure': 'Stoma-free survival', 'timeFrame': 'At one and three years after surgery', 'description': 'Stoma-free survival defined as survival without a diverting or permanent stoma following left-sided colorectal surgery.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Single-stapled anastomosis', 'Colorectal anastomosis', 'Anastomotic leakage', 'Colorectal surgery', 'Left-sided colon resection', 'Partial mesorectal excision'], 'conditions': ['Colorectal Cancer', 'Colorectal Anastomosis', 'Anastomotic Leakage', 'Diverticular Disease of Left Side of Colon']}, 'descriptionModule': {'briefSummary': '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).\n\nThe 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.\n\nThe main questions it aims to answer are:\n\nWhat is the rate of anastomotic leakage within 90 days after surgery in patients operated with the single-stapled technique?\n\nIs the single-stapled technique feasible and safe across different surgical approaches (open, laparoscopic, and robot-assisted surgery) in a multicenter setting?\n\nFurthermore, 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.\n\nParticipants 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.\n\nThe 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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': '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.\n\nPatients 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.', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Age ≥ 18 years.\n* 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).\n* Benign or malignant indication.\n* Prospective cohort: Ability to provide written informed consent.\n* Retrospective cohort: Eligible patients operated during 2023-2025 at participating centers, identified through medical record review, meeting the same surgical inclusion criteria.\n\nExclusion Criteria:\n\n* Total mesorectal excision (TME) (e.g., low rectal cancer surgery requiring TME).\n* Non-left-sided colorectal resections (e.g., right-sided colectomy) or procedures outside the study-defined operations.\n* Surgery not involving a colorectal anastomosis (e.g., end colostomy/Hartmann's procedure without anastomosis).\n* Emergency/urgent colorectal resection (non-elective surgery).\n* Prospective cohort: Inability to provide informed consent."}, 'identificationModule': {'nctId': 'NCT07417358', 'acronym': 'SST', 'briefTitle': 'Single-Stapled Technique for Colorectal Anastomosis', 'organization': {'class': 'OTHER', 'fullName': 'Umeå University'}, 'officialTitle': 'Single-Stapled Technique for Colorectal Anastomosis After Left-Sided Colectomy, Sigmoid Resection or Partial Mesorectal Excision: A Multicentre Prospective Observational Cohort Study', 'orgStudyIdInfo': {'id': 'SST-MC-2025'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Prospective single-stapled technique cohort', 'description': '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.', 'interventionNames': ['Procedure: Single-stapled colorectal anastomosis']}, {'label': 'Retrospective double-stapled technique cohort', 'description': '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.', 'interventionNames': ['Procedure: Double-stapled colorectal anastomosis']}], 'interventions': [{'name': 'Single-stapled colorectal anastomosis', 'type': 'PROCEDURE', 'description': '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.', 'armGroupLabels': ['Prospective single-stapled technique cohort']}, {'name': 'Double-stapled colorectal anastomosis', 'type': 'PROCEDURE', 'description': '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.', 'armGroupLabels': ['Retrospective double-stapled technique cohort']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Gothenburg', 'status': 'RECRUITING', 'country': 'Sweden', 'contacts': [{'name': 'Martin Rutegård, MD, PhD', 'role': 'CONTACT', 'email': 'martin.rutegard@vgregion.se', 'phone': '+4631 342 10 00'}], 'facility': 'Östra Sahlgrenska University Hospital', 'geoPoint': {'lat': 57.70716, 'lon': 11.96679}}, {'city': 'Luleå', 'status': 'RECRUITING', 'country': 'Sweden', 'contacts': [{'name': 'Christoffer Odensten, MD, PhD', 'role': 'CONTACT', 'email': 'christoffer.odensten@umu.se', 'phone': '+46920 28 20 00'}], 'facility': 'Sunderby Hospital', 'geoPoint': {'lat': 65.58415, 'lon': 22.15465}}, {'city': 'Malmo', 'status': 'RECRUITING', 'country': 'Sweden', 'contacts': [{'name': 'Erik Agger, MD, PhD', 'role': 'CONTACT', 'phone': '+4640 33 10 00'}], 'facility': 'Skåne University Hospital', 'geoPoint': {'lat': 55.60587, 'lon': 13.00073}}, {'city': 'Umeå', 'status': 'RECRUITING', 'country': 'Sweden', 'contacts': [{'name': 'Oskar Grahn, MD, PhD', 'role': 'CONTACT', 'email': 'oskar.grahn@umu.se', 'phone': '+46907850000'}], 'facility': 'Surgical Centre, Umeå University Hospital', 'geoPoint': {'lat': 63.82842, 'lon': 20.25972}}, {'city': 'Uppsala', 'status': 'RECRUITING', 'country': 'Sweden', 'contacts': [{'name': 'Malin Enblad, MD, PhD', 'role': 'CONTACT', 'email': 'malin.enblad@uu.se', 'phone': '+4618 611 00 00'}], 'facility': 'Uppsala University Hospital', 'geoPoint': {'lat': 59.85882, 'lon': 17.63889}}], 'centralContacts': [{'name': 'Oskar Grahn, MD, PhD', 'role': 'CONTACT', 'email': 'oskar.grahn@umu.se', 'phone': '+46907850000'}], 'overallOfficials': [{'name': 'Oskar Grahn, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Umea University / Region Vasterbotten'}, {'name': 'Martin Rutegård, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Ostra Sahlgrenska University Hospital, Gothenburg, Sweden'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Umeå University', 'class': 'OTHER'}, 'collaborators': [{'name': 'Sahlgrenska University Hospital', 'class': 'OTHER'}, {'name': 'Skane University Hospital', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'MD, PhD', 'investigatorFullName': 'Oskar Grahn', 'investigatorAffiliation': 'Umeå University'}}}}