Ignite Creation Date:
2025-12-24 @ 6:29 PM
Ignite Modification Date:
2025-12-26 @ 3:24 PM
Study NCT ID:
NCT07056868
Status:
NOT_YET_RECRUITING
Last Update Posted:
2025-07-09
First Post:
2025-06-29
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Prospective Randomized Controlled Trial Comparing Extraperitoneal Stoma Creation Via the Arcuate Line Approach Versus Conventional Transperitoneal Stoma Formation for the Prevention of Parastomal Hernia
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 200}}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2025-08-01', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-06', 'completionDateStruct': {'date': '2028-10-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-06-29', 'studyFirstSubmitDate': '2025-06-29', 'studyFirstSubmitQcDate': '2025-06-29', 'lastUpdatePostDateStruct': {'date': '2025-07-09', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2025-07-09', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2028-08-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Incidence of Parastomal Hernia', 'timeFrame': '36 months postoperatively', 'description': 'The occurrence of parastomal hernia will be assessed at 36 months after surgery through both clinical examination and abdominal CT imaging. Parastomal hernia will be defined based on radiological criteria (e.g., herniation of abdominal contents adjacent to the stoma) and/or physical examination findings (bulging or protrusion around the stoma site). The primary endpoint is the proportion of patients in each group who develop parastomal hernia within the follow-up period.'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Parastomal Hernia', 'Rectal Surgery', 'Stoma Complications', 'Extraperitoneal Stoma', 'Surgical Technique Comparison']}, 'descriptionModule': {'briefSummary': 'This study is a prospective, randomized controlled trial designed to compare two surgical techniques for stoma creation in patients undergoing colorectal surgery. The trial evaluates whether an extraperitoneal stoma created via the arcuate line approach can reduce the risk of developing parastomal hernia compared to the conventional transperitoneal stoma formation. Parastomal hernia is a common complication after stoma surgery, often requiring additional treatment or surgery. By testing a novel surgical route that avoids entering the abdominal cavity, this study aims to improve postoperative outcomes and quality of life for patients requiring a permanent stoma.', 'detailedDescription': 'Parastomal hernia (PSH) is one of the most common long-term complications following stoma creation, with incidence rates reported as high as 30-50%. Conventional stoma formation typically uses a transperitoneal route, which may leave potential gaps in the abdominal wall through which herniation can occur.\n\nRecent anatomical and surgical advances have proposed the arcuate line approach for extraperitoneal stoma creation, allowing the stoma to be tunneled outside the peritoneal cavity while preserving abdominal wall integrity. However, robust prospective evidence supporting its clinical benefits remains limited.\n\nThis randomized controlled trial will compare the arcuate line extraperitoneal approach with the traditional transperitoneal method, focusing on the incidence of parastomal hernia as the primary outcome. Secondary outcomes include postoperative complications, operative time, stoma function, and quality of life.\n\nThe results may provide high-level evidence to guide best practices in stoma surgery.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Age 18-80 years\n* Scheduled for laparoscopic abdominoperineal resection\n\nWritten informed consent\n\nExclusion Criteria:\n\n* Previous abdominal wall hernia\n\nEmergency surgery\n\nSevere comorbidities prohibiting safe surgery\n\nPrior lower abdominal surgery affecting stoma site'}, 'identificationModule': {'nctId': 'NCT07056868', 'briefTitle': 'A Prospective Randomized Controlled Trial Comparing Extraperitoneal Stoma Creation Via the Arcuate Line Approach Versus Conventional Transperitoneal Stoma Formation for the Prevention of Parastomal Hernia', 'organization': {'class': 'OTHER', 'fullName': 'Qilu Hospital of Shandong University'}, 'officialTitle': 'A Prospective Randomized Controlled Trial Comparing Extraperitoneal Stoma Creation Via the Arcuate Line Approach Versus Conventional Transperitoneal Stoma Formation for the Prevention of Parastomal Hernia', 'orgStudyIdInfo': {'id': 'extraperitoneal colostomy'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'extraperitoneal colostomy', 'description': 'Patients in this group will undergo extraperitoneal stoma creation using the arcuate line approach. This technique involves creating a stoma through the extraperitoneal space by accessing the posterior sheath at or below the arcuate line, thereby avoiding direct peritoneal entry. The goal is to reduce the risk of parastomal hernia by maintaining abdominal wall integrity and preventing intra-abdominal content herniation around the stoma.', 'interventionNames': ['Procedure: extraperitoneal colostomy']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'transperitoneal colostomy', 'description': 'Patients in this group will receive a conventional transperitoneal stoma. In this approach, the stoma is brought out through the abdominal wall via a peritoneal opening, which is the standard method used in colorectal surgery. This technique serves as the control for evaluating whether the arcuate line approach offers improved outcomes, particularly in reducing parastomal hernia incidence.', 'interventionNames': ['Procedure: transperitoneal colostomy']}], 'interventions': [{'name': 'extraperitoneal colostomy', 'type': 'PROCEDURE', 'description': 'Patients in this group will undergo extraperitoneal stoma creation using the arcuate line approach. This technique involves creating a stoma through the extraperitoneal space by accessing the posterior sheath at or below the arcuate line, thereby avoiding direct peritoneal entry. The goal is to reduce the risk of parastomal hernia by maintaining abdominal wall integrity and preventing intra-abdominal content herniation around the stoma.', 'armGroupLabels': ['extraperitoneal colostomy']}, {'name': 'transperitoneal colostomy', 'type': 'PROCEDURE', 'description': 'Patients in this group will receive a conventional transperitoneal stoma. In this approach, the stoma is brought out through the abdominal wall via a peritoneal opening, which is the standard method used in colorectal surgery. This technique serves as the control for evaluating whether the arcuate line approach offers improved outcomes, particularly in reducing parastomal hernia incidence.', 'armGroupLabels': ['transperitoneal colostomy']}]}, 'contactsLocationsModule': {'centralContacts': [{'name': 'Xiang Zhang, M.D. Ph.D.', 'role': 'CONTACT', 'email': 'xiang.zhang02@hotmail.com', 'phone': '+8618560089182'}, {'name': 'Yanlei Wang, M.D. Ph.D.', 'role': 'CONTACT', 'phone': '+8618560085128'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Qilu Hospital of Shandong University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Dr.', 'investigatorFullName': 'XIANG ZHANG', 'investigatorAffiliation': 'Qilu Hospital of Shandong University'}}}}