A Randomised Controlled Trial Comparing the Quality of Life After Nylon Darn Repair of Inguinal Hernia to Polypropylene Mesh Repair at St. Luke Hospital, Kasei-Ghana
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 158
- 试验地点
- 1
- 主要终点
- Core Outcome Measures Index - Hernia (COMI - Hernia) score to measure quality of life
研究概览
简要总结
Inguinal hernia repair may be done by the nylon darn, polypropylene mesh and other methods. Polypropylene mesh is established in the literature as the standard of care for inguinal hernia repair. It is however expensive and not readily available in our community hospitals. Nylon darn repair is widely used in our hospitals. We think that the quality of life following nylon darn repair and polypropylene mesh repair is similar. In order to find out, we are recruiting 79 patients to undergo nylon darn repair for their inguinal hernia and another 79 patients to undergo polypropylene mesh repair for their inguinal hernia repair.
We are doing research to compare the quality of life after nylon darn repair of inguinal hernia to polypropylene mesh repair in patients aged 18 years to 80 years who come to St. Luke Hospital for their first-ever inguinal hernia repair.
详细描述
This will be a randomised controlled trial of patients undergoing polypropylene mesh and nylon darn repair for inguinal hernias at St. Luke Hospital, Kasei, Ghana.
The study will be conducted at the St. Luke Hospital, Kasei, Ghana. St. Luke Hospital is a primary hospital facility situated in the Ejura-Sekyedumase district of Ghana.
The surgical unit of the hospital has 58 beds and offers specialist surgical services through the outpatient's clinic, 24-hour emergency unit and the operating theatre.
Elective groin hernia repairs are performed daily by the surgical team comprising specialist surgeon, medical officers, anaesthetists and perioperative nurses. Both nylon darn technique and mesh repairs are performed.
SAMPLE SIZE:
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Double (Participant, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients, 18 years and above, presenting with primary reducible inguinal hernias
- •Patients, 18 years and above, with irreducible inguinal hernias which is neither obstructed nor strangulated.
排除标准
- •Patients who do not consent to participate in the study.
- •Patients presenting with recurrent, obstructed or strangulated hernias
- •Patients with bilateral hernias
- •Patients with immunosuppression (uncontrolled diabetes mellitus, malnutrition, patients on long-term steroids, known AIDS patients)
- •Patients with chronic debilitating illnesses (chronic renal or liver failure, congestive cardiac failure) and urinary bladder outlet obstruction
- •Concomitant repair of another abdominal hernia e.g. umbilical hernia
- •Hernia repair combined with another surgical procedure
- •Patients under the age of 18 years and over 80 years
- •Pregnant women
- •ASA score 4 or more
结局指标
主要结局
Core Outcome Measures Index - Hernia (COMI - Hernia) score to measure quality of life
时间窗: 3 months
Pre-operative COMI-hernia score compared to post-operative COMI-hernia score. The score ranges from 0 to 10. A higher score correlates with a worse outcome and lower scores indicate good outcomes
次要结局
- Number of participants with testicular swelling(3 to 7 days)
- Number of participants with seroma(3 to 7 days)
- Number of participants with surgical site infection(5 days)
- Number of participants with scrotal/wound haematoma(3 to 7 days)
研究者
Edward Amoah Boateng
Principal Investigator
West African College of Surgeons