A Retrospective Study Comparing the Incidence of Parastomal Hernia After Mesenteric Molding Suturing and Non-molding Suturing in Colostomy Surgery
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 11,243
- 主要终点
- Incidence of PSH within one year postoperatively
研究概览
简要总结
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 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.
详细描述
-
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:
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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.
研究组 & 干预措施
Regular
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.
干预措施: Mesenteric Molding Suturing Group (Procedure)
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:
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.
干预措施: Regular (Procedure)
结局指标
主要结局
Incidence of PSH within one year postoperatively
时间窗: 1 year
Incidence of PSH within one year postoperatively
次要结局
- Incidence of stoma-related complications(1 year)
- Operative time and time to stoma function recovery(1 year)
研究者
Yueming Sun
Prof.
The First Affiliated Hospital with Nanjing Medical University