Parastomal HerniaNCT07056868
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
A study testing extraperitoneal colostomy and transperitoneal colostomy in people with Parastomal Hernia and Rectal Surgery, run by Qilu Hospital of Shandong University.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Parastomal Hernia, Rectal Surgery, Stoma Complications
- What is being tested?
- extraperitoneal colostomy and transperitoneal colostomy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- No sites listed yet
- Study dates
- 1 Aug 2025to 31 Oct 2028
- Phase
- Interventional
- 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 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age 18-80 years
- Scheduled for laparoscopic abdominoperineal resection
- Written informed consent
Who cannot join
- Previous abdominal wall hernia
- Emergency surgery
- Severe comorbidities prohibiting safe surgery
- Prior lower abdominal surgery affecting stoma site
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
Yanlei Wang, M.D. Ph.D. contact
About this study
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.
Read the detailed description
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.
Recent 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.
This 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.
The results may provide high-level evidence to guide best practices in stoma surgery.
- Conditions
- Parastomal Hernia, Rectal Surgery, Stoma Complications, Extraperitoneal Stoma, Surgical Technique Comparison
- Being tested
- extraperitoneal colostomy, transperitoneal colostomy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
extraperitoneal colostomyProcedure or surgery
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.
transperitoneal colostomyProcedure or surgery
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.
| Study group | Role | What they receive |
|---|---|---|
| extraperitoneal colostomy | Experimental | 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. Receives: Procedure: extraperitoneal colostomy |
| transperitoneal colostomy | Active comparator | 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. Receives: Procedure: transperitoneal colostomy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of Parastomal Hernia
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.
Measured: 36 months postoperatively
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jul 2025
- Study start1 Aug 2025 (estimated)
- Primary completion1 Aug 2028 (estimated)
- Study completion31 Oct 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Parastomal HerniaStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Outcomes assessor
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Qilu Hospital of Shandong University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, XIANG ZHANG, Qilu Hospital of Shandong University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07056868
- Sponsor's protocol ID
- extraperitoneal colostomy
- Status last verified
- Jun 2025
- First submitted
- 29 Jun 2025
- Last updated
- 9 Jul 2025
- Results posted
- 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 9 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official 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
- ClinicalTrials.gov ID
- NCT07056868
- Acronym / sponsor ID
- extraperitoneal colostomy
- Conditions
- Parastomal Hernia, Rectal Surgery, Stoma Complications, Extraperitoneal Stoma, Surgical Technique Comparison
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Qilu Hospital of Shandong UniversityUniversity, hospital or other
- Study start
- 1 Aug 2025 (estimated)
- Primary completion
- 1 Aug 2028 (estimated)
- Study completion
- 31 Oct 2028 (estimated)
- First posted
- 9 Jul 2025 (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.
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.
Detailed description
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.
Recent 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.
This 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.
The results may provide high-level evidence to guide best practices in stoma surgery.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| extraperitoneal colostomy | Experimental | Procedure: extraperitoneal colostomyPatients 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. |
| transperitoneal colostomy | Active comparator | Procedure: transperitoneal colostomyPatients 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. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Age 18-80 years
- Scheduled for laparoscopic abdominoperineal resection
- Written informed consent
Key exclusion criteria (4 listed)
- Previous abdominal wall hernia
- Emergency surgery
- Severe comorbidities prohibiting safe surgery
- Prior lower abdominal surgery affecting stoma site
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 |
|---|---|---|
| extraperitoneal colostomyPatients 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. | Procedure or surgery | extraperitoneal colostomy |
| transperitoneal colostomyPatients 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. | Procedure or surgery | transperitoneal colostomy |
Primary outcome
Incidence of Parastomal Hernia
Time frame: 36 months postoperatively
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.
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 9 Jul 2025.
- Individual participant dataSharing planned: No
Related trials for Parastomal Hernia
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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.
Yanlei Wang, M.D. Ph.D. contact
Questions about this trial
What is this clinical trial studying?
A study testing extraperitoneal colostomy and transperitoneal colostomy in people with Parastomal Hernia and Rectal Surgery, run by Qilu Hospital of Shandong University.
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 3 inclusion and 4 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: opening soon, as of the sponsor's last update on 9 Jul 2025. Status can change between updates, so confirm with the study contact before making plans.
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 Xiang Zhang, M.D. Ph.D. (+8618560089182, xiang.zhang02@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of Parastomal Hernia (time frame: 36 months postoperatively). 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 9 Jul 2025.