Parastomal HerniaNCT06674187
Comparing the Incidence of Parastomal Hernia After Mesenteric Molding Suturing and Non-molding Suturing in Colostomy Surgery
A study testing Regular and Mesenteric Molding Suturing Group in people with Parastomal Hernia, run by The First Affiliated Hospital with Nanjing Medical University at 1 site in China.
Trial summary
Research Background Colostomy surgery is a common surgical procedure widely used for the treatment of various gastrointestinal diseases, including rectal cancer, ulcerative colitis, and Crohn's disease. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Parastomal Hernia
- What is being tested?
- Regular and Mesenteric Molding Suturing Group
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 234 participants
- Where
- 1 siteChina
- Study dates
- 1 Dec 2024to 31 Dec 2027
- 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 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age 18 years or older.
- Patients requiring colostomy surgery.
- Ability to provide written informed consent.
- Expected survival of more than one year.
- No severe comorbidities such as heart, lung, liver, or kidney dysfunction.
Who cannot join
- Pregnant or breastfeeding women.
- History of major abdominal surgery that could affect the development of PSH.
- Mental illness that impairs understanding of the study content and ability to give informed consent.
- Patients receiving immunosuppressive therapy or chemotherapy.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
First Affiliated Hospital of Nanjing Medical University
Nanjing, Jiangsu, 210029
Yueming Sun, MD, 862568305386, sunyueming@njmu.edu.cn
About this study
Official title: A Prospective Randomized Controlled Trial Comparing the Incidence of Parastomal Hernia After Mesenteric Molding Suturing and Non-molding Suturing in Colostomy Surgery
Research Background
Colostomy surgery is a common surgical procedure widely used for the treatment of various gastrointestinal diseases, including rectal cancer, ulcerative colitis, and Crohn's disease. Although this surgery can significantly improve patients' quality of life and prognosis, the incidence of postoperative complications, particularly parastomal hernia (PSH), is relatively high. PSH refers to the formation of an abdominal wall hernia around the stoma, with an incidence rate that can reach up to 50%. PSH not only affects patients' quality of life but can also lead to pain, stoma dysfunction, and the need for reoperation, increasing medical costs and patient burden. Therefore, how to effectively prevent PSH has become an important topic in clinical research.
Read more
Epidemiology of Parastomal Hernia
The incidence of PSH varies across different studies, ranging from 10% to 50%. This variation may be due to differences in study design, patient characteristics, and surgical techniques. A systematic review and meta-analysis showed that the incidence of PSH differs significantly among different surgical techniques, with higher rates observed in traditional non-molding suturing techniques. Another large cohort study found that the incidence of PSH varies among different age groups and patients with different underlying diseases, suggesting that PSH occurrence may be influenced by multiple factors.
Risk Factors for Parastomal Hernia
- Patient Factors:
- Advanced Age: Older patients have reduced tissue elasticity and muscle strength, making them more susceptible to PSH.
- Obesity: Obese patients have higher intra-abdominal pressure, increasing the risk of PSH.
- Smoking: Smoking impairs wound healing, increasing the risk of PSH.
- Chronic Obstructive Pulmonary Disease (COPD): COPD patients often experience coughing and breathing difficulties, leading to increased intra-abdominal pressure and a higher risk of PSH.
- Diabetes: Diabetic patients have poorer wound healing capabilities, making them more prone to PSH.
- Malnutrition: Malnutrition impairs tissue repair, increasing the risk of PSH.
- Surgical Factors:
- Surgical Technique: Different surgical techniques have a significant impact on the incidence of PSH. Traditional non-molding suturing techniques, which lack support for the tissues around the stoma, have a higher incidence of PSH.
- Stoma Location: Improper stoma placement, such as outside the rectus abdominis muscle, increases the risk of PSH.
- Stoma Size: An oversized or undersized stoma can affect stoma function and increase the risk of PSH.
- Use of Mesh: Using synthetic or biological mesh can significantly reduce the incidence of PSH. However, the use of mesh may bring risks of infection and other complications.
- Postoperative Factors:
- Early Mobilization: Appropriate early mobilization promotes circulation and wound healing, but excessive activity can increase intra-abdominal pressure and the risk of PSH.
- Increased Intra-abdominal Pressure: Activities such as coughing, constipation, and heavy lifting can increase intra-abdominal pressure and the risk of PSH.
- Infection: Postoperative infections can impair wound healing and increase the risk of PSH.
Prevention Strategies for Parastomal Hernia
- Improvement in Surgical Techniques:
- Mesenteric Molding Suturing: In recent years, mesenteric molding suturing has gained attention due to its potential advantages. Mesenteric molding suturing strengthens the support around the stoma, reducing the protrusion of abdominal contents and thus lowering the incidence of PSH. A retrospective study showed that patients who underwent mesenteric molding suturing had a significantly lower incidence of PSH compared to those who received traditional non-molding suturing. However, these studies are mostly retrospective and have certain biases and limitations, lacking high-quality prospective randomized controlled trials to validate these findings.
- Use of Mesh: Some studies have shown that using synthetic or biological mesh can significantly reduce the incidence of PSH. The mesh provides additional support, reducing the protrusion of abdominal contents and thus lowering the risk of PSH. However, the use of mesh may bring risks of infection and other complications, requiring a careful balance of benefits and risks.
- Postoperative Care:
- Early Mobilization Guidance: Appropriate early mobilization promotes circulation and wound healing, but excessive activity should be avoided to prevent increased intra-abdominal pressure.
- Avoidance of Increased Intra-abdominal Pressure: Patients should be advised to avoid activities that can increase intra-abdominal pressure, such as coughing, constipation, and heavy lifting.
- Infection Prevention: Keeping the stoma area clean and dry and promptly managi
- Conditions
- Parastomal Hernia
- Being tested
- Regular, Mesenteric Molding Suturing Group
- Keywords
- Colostomy Surgery, Parastomal Hernia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RegularProcedure or surgery
Also called Non-molding Suturing Group
The stoma surgery will be performed using conventional non-molding suturing techniques. The specific steps include:
- Select an appropriate stoma site, typically within the rectus abdominis muscle.
- Perform routine suturing around the stoma without additional mesentery shaping.
- Form the stoma, ensuring a tight fit of the surrounding tissues.
Mesenteric Molding Suturing GroupProcedure or surgery
During the stoma surgery, the mesentery will be shaped and sutured to enhance the support around the stoma and reduce the risk of hernia formation. The specific steps include:
- Select an appropriate stoma site, typically within the rectus abdominis muscle.
- Separate the mesentery around the stoma and shape it into a sturdy support structure.
- Use non-absorbable sutures to fix the shaped mesentery to the abdominal wall, forming a sturdy support structure.
- Form the stoma on the support structure, ensuring a tight fit of the surrounding tissues.
| Study group | Role | What they receive |
|---|---|---|
| Regular | Active comparator | The stoma surgery will be performed using conventional non-molding suturing techniques. The specific steps include:
1. Select an appropriate stoma site, typically within the rectus abdominis muscle.
2. Perform routine suturing around the stoma without additional mesentery shaping.
3. Form the stoma, ensuring a tight fit of the surrounding tissues. Receives: Procedure: Mesenteric Molding Suturing Group |
| Mesenteric Molding Suturing | Experimental | During the stoma surgery, the mesentery will be shaped and sutured to enhance the support around the stoma and reduce the risk of hernia formation. The specific steps include:
1. Select an appropriate stoma site, typically within the rectus abdominis muscle.
2. Separate the mesentery around the stoma and shape it into a sturdy support structure.
3. Use non-absorbable sutures to fix the shaped mesentery to the abdominal wall, forming a sturdy support structure.
4. Form the stoma on the support structure, ensuring a tight fit of the surrounding tissues. Receives: Procedure: Regular |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of PSH within one year postoperatively
Incidence of PSH within one year postoperatively, from CT or body check
Measured: 1 year
Secondary outcomes (3)
Incidence of stoma-related complications
stoma bleeding, stoma necrosis, and stoma prolapse through clinical observation.
Measured: 1 year
Operative time and time to stoma function recovery
Operative time and time to stoma function recovery through questionnaire survey
Measured: 1 year
Quality of life assessment
Quality of life assessment through questionnaire survey
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Nov 2024
- Study start1 Dec 2024
- Primary completion31 Dec 2027 (estimated)
- Study completion31 Dec 2027 (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.
- More trials run by The First Affiliated Hospital with Nanjing Medical UniversityThe sponsor's other registered studies.
- 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
- None (open label)
- Enrolment
- 234 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Yueming Sun, The First Affiliated Hospital with Nanjing Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06674187
- Sponsor's protocol ID
- Parastomal Hernia-01
- Status last verified
- Jan 2026
- First submitted
- 30 Oct 2024
- Last updated
- 28 Jul 2026
- Results posted
- No
- Data monitoring committee
- Yes
- 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 28 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective Randomized Controlled Trial Comparing the Incidence of Parastomal Hernia After Mesenteric Molding Suturing and Non-molding Suturing in Colostomy Surgery
- ClinicalTrials.gov ID
- NCT06674187
- Acronym / sponsor ID
- Parastomal Hernia-01
- Conditions
- Parastomal Hernia
- Keywords
- Colostomy Surgery, Parastomal Hernia
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 234 participants (estimated)
- Lead sponsor
- The First Affiliated Hospital with Nanjing Medical UniversityUniversity, hospital or other
- Study start
- 1 Dec 2024 (actual)
- Primary completion
- 31 Dec 2027 (estimated)
- Study completion
- 31 Dec 2027 (estimated)
- First posted
- 5 Nov 2024 (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.
Research Background
Colostomy surgery is a common surgical procedure widely used for the treatment of various gastrointestinal diseases, including rectal cancer, ulcerative colitis, and Crohn's disease. Although this surgery can significantly improve patients' quality of life and prognosis, the incidence of postoperative complications, particularly parastomal hernia (PSH), is relatively high. PSH refers to the formation of an abdominal wall hernia around the stoma, with an incidence rate that can reach up to 50%. PSH not only affects patients' quality of life but can also lead to pain, stoma dysfunction, and the need for reoperation, increasing medical costs and patient burden. Therefore, how to effectively prevent PSH has become an important topic in clinical research.
Epidemiology of Parastomal Hernia
The incidence of PSH varies across different studies, ranging from 10% to 50%. This variation may be due to differences in study design, patient characteristics, and surgical techniques. A systematic review and meta-analysis showed that the incidence of PSH differs significantly among different surgical techniques, with higher rates observed in traditional non-molding suturing techniques. Another large cohort study found that the incidence of PSH varies among different age groups and patients with different underlying diseases, suggesting that PSH occurrence may be influenced by multiple factors.
Risk Factors for Parastomal Hernia
- Patient Factors:
- Advanced Age: Older patients have reduced tissue elasticity and muscle strength, making them more susceptible to PSH.
- Obesity: Obese patients have higher intra-abdominal pressure, increasing the risk of PSH.
- Smoking: Smoking impairs wound healing, increasing the risk of PSH.
- Chronic Obstructive Pulmonary Disease (COPD): COPD patients often experience coughing and breathing difficulties, leading to increased intra-abdominal pressure and a higher risk of PSH.
- Diabetes: Diabetic patients have poorer wound healing capabilities, making them more prone to PSH.
- Malnutrition: Malnutrition impairs tissue repair, increasing the risk of PSH.
- Surgical Factors:
- Surgical Technique: Different surgical techniques have a significant impact on the incidence of PSH. Traditional non-molding suturing techniques, which lack support for the tissues around the stoma, have a higher incidence of PSH.
- Stoma Location: Improper stoma placement, such as outside the rectus abdominis muscle, increases the risk of PSH.
- Stoma Size: An oversized or undersized stoma can affect stoma function and increase the risk of PSH.
- Use of Mesh: Using synthetic or biological mesh can significantly reduce the incidence of PSH. However, the use of mesh may bring risks of infection and other complications.
- Postoperative Factors:
- Early Mobilization: Appropriate early mobilization promotes circulation and wound healing, but excessive activity can increase intra-abdominal pressure and the risk of PSH.
- Increased Intra-abdominal Pressure: Activities such as coughing, constipation, and heavy lifting can increase intra-abdominal pressure and the risk of PSH.
- Infection: Postoperative infections can impair wound healing and increase the risk of PSH.
Prevention Strategies for Parastomal Hernia
- Improvement in Surgical Techniques:
- Mesenteric Molding Suturing: In recent years, mesenteric molding suturing has gained attention due to its potential advantages. Mesenteric molding suturing strengthens the support around the stoma, reducing the protrusion of abdominal contents and thus lowering the incidence of PSH. A retrospective study showed that patients who underwent mesenteric molding suturing had a significantly lower incidence of PSH compared to those who received traditional non-molding suturing. However, these studies are mostly retrospective and have certain biases and limitations, lacking high-quality prospective randomized controlled trials to validate these findings.
- Use of Mesh: Some studies have shown that using synthetic or biological mesh can significantly reduce the incidence of PSH. The mesh provides additional support, reducing the protrusion of abdominal contents and thus lowering the risk of PSH. However, the use of mesh may bring risks of infection and other complications, requiring a careful balance of benefits and risks.
- Postoperative Care:
- Early Mobilization Guidance: Appropriate early mobilization promotes circulation and wound healing, but excessive activity should be avoided to prevent increased intra-abdominal pressure.
- Avoidance of Increased Intra-abdominal Pressure: Patients should be advised to avoid activities that can increase intra-abdominal pressure, such as coughing, constipation, and heavy lifting.
- Infection Prevention: Keeping the stoma area clean and dry and promptly managi
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Regular | Active comparator | Procedure: Mesenteric Molding Suturing GroupThe stoma surgery will be performed using conventional non-molding suturing techniques. The specific steps include: 1. Select an appropriate stoma site, typically within the rectus abdominis muscle. 2. Perform routine suturing around the stoma without additional mesentery shaping. 3. Form the stoma, ensuring a tight fit of the surrounding tissues. |
| Mesenteric Molding Suturing | Experimental | Procedure: RegularDuring the stoma surgery, the mesentery will be shaped and sutured to enhance the support around the stoma and reduce the risk of hernia formation. The specific steps include: 1. Select an appropriate stoma site, typically within the rectus abdominis muscle. 2. Separate the mesentery around the stoma and shape it into a sturdy support structure. 3. Use non-absorbable sutures to fix the shaped mesentery to the abdominal wall, forming a sturdy support structure. 4. Form the stoma on the support structure, ensuring a tight fit of the surrounding tissues. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Age 18 years or older.
- Patients requiring colostomy surgery.
- Ability to provide written informed consent.
- Expected survival of more than one year.
- No severe comorbidities such as heart, lung, liver, or kidney dysfunction.
Key exclusion criteria (4 listed)
- Pregnant or breastfeeding women.
- History of major abdominal surgery that could affect the development of PSH.
- Mental illness that impairs understanding of the study content and ability to give informed consent.
- Patients receiving immunosuppressive therapy or chemotherapy.
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 |
|---|---|---|
| RegularAlso: Non-molding Suturing GroupThe stoma surgery will be performed using conventional non-molding suturing techniques. The specific steps include: 1. Select an appropriate stoma site, typically within the rectus abdominis muscle. 2. Perform routine suturing around the stoma without additional mesentery shaping. 3. Form the stoma, ensuring a tight fit of the surrounding tissues. | Procedure or surgery | Mesenteric Molding Suturing |
| Mesenteric Molding Suturing GroupDuring the stoma surgery, the mesentery will be shaped and sutured to enhance the support around the stoma and reduce the risk of hernia formation. The specific steps include: 1. Select an appropriate stoma site, typically within the rectus abdominis muscle. 2. Separate the mesentery around the stoma and shape it into a sturdy support structure. 3. Use non-absorbable sutures to fix the shaped mesentery to the abdominal wall, forming a sturdy support structure. 4. Form the stoma on the support structure, ensuring a tight fit of the surrounding tissues. | Procedure or surgery | Regular |
Primary outcome
Incidence of PSH within one year postoperatively
Time frame: 1 year
Incidence of PSH within one year postoperatively, from CT or body check
3 secondary outcomes
Incidence of stoma-related complications
Time frame: 1 year
Operative time and time to stoma function recovery
Time frame: 1 year
Quality of life assessment
Time frame: 1 year
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 28 Jul 2026.
- Individual participant dataSharing planned: No
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Regular and Mesenteric Molding Suturing Group in people with Parastomal Hernia, run by The First Affiliated Hospital with Nanjing Medical University at 1 site in China.
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 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: looking for participants now, as of the sponsor's last update on 28 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. 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 Junwei Sun, M.D (+862568306026, pepsitjw@njmu.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of PSH within one year postoperatively (time frame: 1 year). 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 28 Jul 2026; AzTrials last refreshed its copy on 8 Nov 2026.