The Laparoscopic Total Extraperitoneal Parastomal Hernia Repair as a Modification of Sugabecker's Operation
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 50
- 试验地点
- 2
- 主要终点
- Recurrence Rate of Parastomal Hernia
研究概览
简要总结
Abstract:
Parastomal hernia is a frequent complication following stoma formation, presenting a significant surgical challenge with high recurrence rates. The present study explores the efficacy of the laparoscopic total extraperitoneal (TEP) approach in parastomal hernia repair, conceived as a modification of the Sugabecker's operation. This prospective work, who analysis aims to evaluate the feasibility, safety, and recurrence rates associated with this minimally invasive technique.
Methods:
A comprehensive review of patients undergoing laparoscopic TEP parastomal hernia repair between 2024 and 2026 will be performed. Patient demographics, operative details, intraoperative complications, postoperative morbidity, recovery times, and hernia recurrence rates will be collate and analyze.
Results:
The study will include 30 patients with a median follow-up period of 1month (firstly viewer's point) and 12 months (second view point ). The all of parastomal hernias will associated with colostomies. Early mobilization will achieve, with most patients returning to their routine activities within 2 weeks.
Discussion:
We anticipate that the data will suggest the laparoscopic TEP technique for parastomal hernia repair is a viable alternative to traditional methods, with a favorable safety profile. The minimally invasive nature of the operation appears to facilitate enhanced recovery while maintaining low recurrence rates. Compared to the original Sugarbaker operation, where the mesh is placed intraperitoneally, the extraperitoneal placement of the mesh in TEP repair minimizes the potential for adhesion formation and related complications. Furthermore, aesthetic outcomes and patient satisfaction reports indicate a positive outlook.
Conclusion:
The laparoscopic TEP approach for parastomal hernia repair offers a modification to the Sugarbaker operation with potential benefits, including reduced operative morbidity, faster recovery, and potentially lower recurrence rates. Extended follow-up and comparison with the traditional approach are warranted to conclusively establish the long-term outcomes of this technique. This study contributes to the evolving surgical management of parastomal hernias, advancing towards less invasive and more patient-centered treatment modalities.
详细描述
Introduction:
Parastomal herniation presents as a common complication following stomal surgeries, creating significant morbidity and adversely impacting the quality of life for patients. Traditional open surgical techniques, including Sugabecker's operation, offer variable success rates and potential complications. This study proposes an adaptation utilizing a laparoscopic total extraperitoneal (TEP) approach, tailored to enhance the original Sugabecker method while aiming to reduce the perioperative morbidity and recurrence rates associated with parastomal hernia repairs.
Objective:
The primary objective of this research is to investigate the laparoscopic TEP parastomal hernia repair as a modification of the Sugabecker's operation and to assess its outcomes in terms of feasibility, safety, and hernia recurrence rate.
Brief Protocol Description:
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Factorial
- 主要目的
- Treatment
- 盲法
- Double (Participant, Investigator)
盲法说明
This clinical trial incorporates a double-blind design. Neither participants nor the surgeons performing the procedures will be informed about whether a patient is receiving the modified Sugarbaker's operation or a standard parastomal hernia repair technique. The intent is to prevent any potential bias in surgical performance and postoperative care. Outcome assessors analyzing recovery data, hernia recurrence rates, and complication rates will also be blinded to the intervention received by each participant. This ensures an unbiased collection and interpretation of data, enhancing the validity of the trial outcomes. Specific measures will have been taken to maintain blinding, including the use of identical operative room setup and post-surgical care protocols, with only the core surgical team aware of the specific intervention being applied. All study personnel involved in data collection, analysis, and patient follow-up will remain blinded until data lock
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adult patients with a confirmed diagnosis of parastomal hernia post-stoma creation surgery;
- •Symptomatic hernias requiring surgical intervention;
- •Able to undergo the surgical approach under general anesthesia;
- •Patients who can provide informed consent.
- •Non-Inclusion Criteria:
- •Patients with contraindications to laparoscopic surgery, such as uncontrolled coagulopathies, severe cardiorespiratory conditions, or extensive intra-abdominal adhesions are excluded. Those with ongoing peritonitis, incarcerated hernias requiring urgent care, or malignancy at the hernia site are also excluded.
排除标准
- •Patients unwilling to provide informed consent;
- •Patients with a life expectancy less than the study follow-up period;
- •Patients who have previously undergone other types of hernia repair, which could confound the operative and postoperative outcomes being measured.
结局指标
主要结局
Recurrence Rate of Parastomal Hernia
时间窗: 1 year post-operation Ensure that the timelines, definitions, and other details reflect the specific procedures and follow-ups that are planned for the clinical trial being discussed.
This outcome measures the rate at which the hernias recur post-surgery after using the laparoscopic total extraperitoneal parastomal hernia repair technique modified from the traditional Sugarbaker's operation. A recurrence constitutes any hernia that reappears in the region of the stoma where the surgery was initially performed.
次要结局
- Length of Hospital Stay(From date of surgery until hospital discharge, assessed up to 30 days)
- Intra-operative Complications(During operation)
- Incidence of Infectious Complications at the Surgical Site and Mesh Placement Area(Assessed at post-operative days 1, 3, 7, 14, and during follow-up visits at 1 month, 3 months, and 6 months)
- Quality of Life Assessment - Short Form Health Survey (SF-36) Score(Assessed pre-operation and at 3 months, 6 months, 1 year, and 2 years post-operation)
- Postoperative Pain Levels -Visual Analog Scale (VAS) for Pain(Assessed at 24 hours, 72 hours, and 7 days post-operation)