Comparative Outcomes of Polyglactin Versus Polypropylene Sutures for Rectus Sheath Closure: A Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 156
- 试验地点
- 2
- 主要终点
- Incisional Hernia rate
研究概览
简要总结
This randomized controlled trial aims to compare the outcomes of Polyglactin (Vicryl) versus Polypropylene (Prolene) sutures for rectus sheath closure in patients undergoing midline laparotomy. The study will evaluate the rates of incisional hernia, surgical site infection (SSI), wound dehiscence, chronic pain, and suture sinus formation. Participants aged 18-70 years, undergoing either elective or emergency laparotomy, will be randomly assigned to receive either Polyglactin or Polypropylene sutures. The primary outcome measure is the incidence of incisional hernia at 6 months, with secondary outcomes including SSI, wound complications, and chronic pain. The study is particularly important in the context of Pakistan, where such comparative data is limited, and aims to provide evidence-based recommendations for optimal suture material selection in general surgery.
详细描述
Study Design This randomized controlled trial is designed to compare the outcomes of two suture materials-Polyglactin 910 (Vicryl) and Polypropylene (Prolene)-for rectus sheath closure after midline laparotomy. The study will be conducted at the Department of General Surgery, Lady Reading Hospital, Peshawar, over 12 months. Participants will be randomly assigned to two groups: Group A (Polyglactin) and Group B (Polypropylene). The primary outcome is the rate of incisional hernia at 6 months postoperatively. Secondary outcomes include surgical site infection (SSI), wound dehiscence, chronic pain, and suture sinus formation.
■ Participants The study will include patients aged 18 to 70 years undergoing elective or emergency midline laparotomy with clean or clean-contaminated wounds (CDC Class I or II).
Inclusion Criteria:
Aged 18-70 years
Elective or emergency laparotomy
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Outcomes Assessor)
盲法说明
This study is single-blind, meaning the participants do not know which suture material they received. The outcomes assessor (surgeon) will also be blinded to the group allocation to reduce bias in outcome assessment.
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age: 18-70 years.
- •Type of Surgery: Patients undergoing elective or emergency midline laparotomy.
- •Wound Classification: Clean or clean-contaminated wounds (CDC Class I or II).
- •Ability to Provide Informed Consent: Participants must be able to understand and sign the informed consent form.
- •Availability for Follow-Up: Participants must be available for 6 months follow-up.
排除标准
- •Contaminated or Dirty Wounds: Patients with CDC Class III or IV wounds.
- •Immunocompromised Conditions: Patients on steroids, chemotherapy, or those with HIV.
- •Previous Midline Laparotomy with Incisional Hernia: Patients who have a history of incisional hernia after midline laparotomy.
- •Severe Malnutrition: Patients with BMI < 16 kg/m² or albumin < 2.5 g/dL.
- •Emergency Laparotomy with Hemodynamic Instability: Patients who are unstable or in a critical condition.
- •Pregnancy: Pregnant women.
- •Need for Temporary Abdominal Closure or Planned Reoperation: Patients requiring staged reoperation or temporary closure.
结局指标
主要结局
Incisional Hernia rate
时间窗: 6 months postoperatively
The primary outcome will assess the rate of incisional hernia at 6 months post-surgery in patients who undergo rectus sheath closure with either Polyglactin 910 (Vicryl) or Polypropylene (Prolene) sutures.
次要结局
- Surgical Site Infection (SSI) Rate(30 days post-surgery)
- Suture Sinus Formation(6 months post-surgery)
- Chronic Pain (Visual Analog Scale, VAS ≥4)(3 months post-surgery)
- Wound Dehiscence(30 days post-surgery)
研究者
Dr. Waseem Ullah
Registrar, General Surgery
Lady Reading Hospital, Pakistan