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Colorectal Cancer (CRC)COMPARISONNCT06674200

A Retrospective Study Comparing the Incidence of Parastomal Hernia After Mesenteric Molding Suturing and Non-molding Suturing in Colostomy Surgery

A study testing Mesenteric Molding Suturing Group and Regular in people with Colorectal Cancer (CRC), run by The First Affiliated Hospital with Nanjing Medical University.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

### Brief Summary Title**: A Retrospective Study Comparing the Incidence of Parastomal Hernia After Mesenteric Molding Suturing and Non-molding Suturing in Colostomy Surgery Background**: Colostomy surgery is a common procedure for treating various gastrointestinal diseases, but it is associated with a high incidence… Read more about this study

Who is it for?
Ages 18 to 75 years
Conditions the study is for
Colorectal Cancer (CRC)
What is being tested?
Mesenteric Molding Suturing Group and Regular
Type of treatment
Surgery or procedure
Could I receive a placebo?
No, everyone receives an active treatment
How many people
11,243 participants
Where
No sites listed yet
Study dates
1 Jan 2002to 1 Oct 2024
Phase
Interventional
Are there results?
None posted in the registry

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.

About this study

### Brief Summary

  • Title**: A Retrospective Study Comparing the Incidence of Parastomal Hernia After Mesenteric Molding Suturing and Non-molding Suturing in Colostomy Surgery
  • Background**:
Read more

Colostomy surgery is a common procedure for treating various gastrointestinal diseases, but it is associated with a high incidence of parastomal hernia (PSH), which can significantly affect patients' quality of life and increase healthcare costs. This study aims to compare the incidence of PSH within one year after colostomy surgery between patients who underwent mesenteric molding suturing and those who underwent non-molding suturing.

  • Objectives**:
  • Primary Objective: To compare the incidence of PSH within one year postoperatively between the mesenteric molding suturing group and the non-molding suturing group.
  • Secondary Objectives: To evaluate the impact of the two suturing methods on stoma-related complications (such as stoma bleeding, stoma necrosis, and stoma prolapse), operative time, and time to stoma function recovery.
  • Methods**:
  • Design: Retrospective cohort study.
  • Participants: Patients who underwent colostomy surgery.
  • Interventions: Mesenteric molding suturing vs. non-molding suturing.
  • Data Collection: Baseline data (age, gender, BMI, medical history) and follow-up data (incidence of PSH, stoma-related complications, operative time, and time to stoma function recovery) were collected from medical records.
  • Statistical Analysis: The primary outcome (incidence of PSH) will be analyzed using the Chi-square test or Fisher's exact test. Secondary outcomes will be analyzed using appropriate statistical methods (e.g., t-test, Mann-Whitney U test, ANOVA).
  • Expected Outcomes**:
  • The study aims to provide evidence on the effectiveness of mesenteric molding suturing in reducing the incidence of PSH and improving postoperative outcomes in colostomy patients.
  • Ethical Considerations**:
  • The study will adhere to the principles of the Declaration of Helsinki.
  • All data will be anonymized to protect patient confidentiality.
  • The study protocol will be approved by the local ethics committee.

This retrospective study will contribute valuable insights into the optimal surgical techniques for reducing the incidence of PSH in colostomy patients, ultimately improving their quality of life and reducing healthcare costs.

Read the detailed description
  • Detailed Description
  • Title A Retrospective Study Comparing the Incidence of Parastomal Hernia After Mesenteric Molding Suturing and Non-molding Suturing in Colostomy Surgery
  • Background Colostomy surgery is a common procedure used for the treatment of various gastrointestinal diseases, including rectal cancer, ulcerative colitis, and Crohn's disease. Despite its benefits, colostomy surgery is associated with a high incidence of postoperative complications, particularly parastomal hernia (PSH). PSH, defined as the formation of an abdominal wall hernia around the stoma, can occur in up to 50% of cases. 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, identifying effective strategies to prevent PSH is crucial.
  • Objectives
  • Primary Objective: To compare the incidence of parastomal hernia within one year after colostomy surgery between patients who underwent mesenteric molding suturing and those who underwent non-molding suturing.
  • Secondary Objectives:
  • To evaluate the impact of the two suturing methods on stoma-related complications such as stoma bleeding, stoma necrosis, and stoma prolapse.
  • To record the operative time and the time to stoma function recovery.
  • To assess changes in patients' quality of life.
  • Methods
  • Design: Retrospective cohort study.
  • Setting: The study will be conducted at [Hospital Name], a tertiary care center with a dedicated colorectal surgery unit.
  • Participants: Patients who underwent colostomy surgery between [Start Date] and [End Date].
  • Inclusion Criteria:
  • Age 18 years or older.
  • Underwent colostomy surgery.
  • Provided written informed consent.
  • Expected survival of more than one year.
  • No severe comorbidities such as heart, lung, liver, or kidney dysfunction.
  • Exclusion Criteria:
  • 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.
  • Interventions
  • Mesenteric Molding Suturing Group:
  • During the stoma surgery, the mesentery is 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.
  • Non-molding Suturing Group:
  • The stoma surgery is 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.
  • Data Collection - Baseline Data:
  • Patient demographic information: age, gender, BMI, etc.
  • Medical history: including surgical history and chronic disease history.
  • Laboratory tests: complete blood count, biochemical indicators, etc.
  • Follow-up Data:
  • One Week Postoperatively: Assess wound healing, record operative time, and time to stoma function recovery.
  • One Month Postoperatively: Evaluate stoma function and record complications such as stoma bleeding, stoma necrosis, and stoma prolapse.
  • Six Months Postoperatively: Repeat the above assessments and perform imaging studies (e.g., ultrasound or CT) to evaluate the incidence of PSH.
  • One Year Postoperatively: Repeat the above assessments and conduct the final statistical analysis of PSH incidence.
  • Statistical Analysis - Primary Outcome Measure: Incidence of PSH within one year postoperatively.
  • Compare the two groups using the Chi-square test or Fisher's exact test.
  • Secondary Outcome Measures:
  • Incidence of stoma-related complications such as stoma bleeding, stoma necrosis, and stoma prolapse: use the Chi-square test or Fisher's exact test.
  • Operative time and time to stoma function recovery: use the t-test or Mann-Whitney U test.
  • Quality of life assessment: use ANOVA or Kruskal-Wallis test.
  • Multivariate Analysis: Use Cox proportional hazards model to assess risk factors for PSH.
  • Ethical Considerations - The study will adhere to the principles of the Declaration of Helsinki.
  • All participants must provide written informed consent.
  • The study protocol must be approved by the local ethics committee.
  • Data will be anonymized to protect patient confidentiality.
  • Expected Outcomes - This study aims to provide scientific evidence for best practices in colostomy surgery, particularly in reducing PSH and other complications.
  • We expect to validate the effectiveness of mesenteric molding suturing in preventing PSH, offering more reliable surgical guidance for clinicians.
  • Study Limitations
  • Open-label Design: May introduce some bias, but it is difficult to achieve double-blinding given the nature of the surgical procedures.
  • Long-term Follow-up: May result in some dropouts, so measures will be taken to minimize the dropout rate.
  • Sample Selection: Potential selection bias, so strict inclusion and exclusion criteria will be applied.

By conducting this detailed retrospective study, we aim to provide robust evidence to guide clinical practice and improve the outcomes for patients undergoing colostomy surgery.

Being tested
Mesenteric Molding Suturing Group, Regular
Keywords
Parastomal Hernia, Mesenteric Molding Suturing, Colostomy Surgery
Medical subject headings
Colorectal Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Mesenteric Molding Suturing GroupProcedure or surgery

    During the stoma surgery, the mesentery is 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.

  • RegularProcedure or surgery

    The stoma surgery is 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.

Study groups in NCT06674200
Study groupRoleWhat they receive
RegularActive comparatorThe stoma surgery is 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.
Receives: Procedure: Mesenteric Molding Suturing Group
Mesenteric Molding Suturing GroupExperimentalDuring the stoma surgery, the mesentery is 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.
Receives: Procedure: Regular

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Incidence of PSH within one year postoperatively

    Incidence of PSH within one year postoperatively

    Measured: 1 year

Secondary outcomes (2)
  1. Incidence of stoma-related complications

    stoma bleeding, stoma necrosis, and stoma prolapse: use the Chi-square test or Fisher's exact test.

    Measured: 1 year

  2. Operative time and time to stoma function recovery

    Operative time and time to stoma function recovery

    Measured: 1 year

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted5 Nov 2024
  2. Study start1 Jan 2002
  3. Primary completion1 Oct 2024
  4. Study completion1 Oct 2024

Resources

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
Non-randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
11,243 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06674200
Sponsor's protocol ID
COMPARISON study
Acronym
COMPARISON
Status last verified
Jan 2024
First submitted
30 Oct 2024
Last updated
5 Nov 2024
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Tang J, Wang L, Ji D, Du J, Jin K, Wang Y, Wang X, Sun Y. Association of Mesenteric Molding Suturing on Parastomal Hernia Incidence: Retrospective Study. J Surg Res. 2025 Nov;315:973-981. doi: 10.1016/j.jss.2025.10.017. Epub 2025 Nov 10.

    PubMed 41218377

Questions about this trial

What is this clinical trial studying?

A study testing Mesenteric Molding Suturing Group and Regular in people with Colorectal Cancer (CRC), run by The First Affiliated Hospital with Nanjing Medical 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 1 inclusion and 2 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: finished, as of the sponsor's last update on 5 Nov 2024. 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?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. 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?

On the ClinicalTrials.gov record for NCT06674200, which also lists 1 linked publication.

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 5 Nov 2024.

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