Task Shifting in InGuinal hErnia Repair Between Surgeons and Non-surgeon Physicians. A Multicentre Randomised Controlled Non-inferiority Trial.
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 1,782
- 主要终点
- Safety 90 days after surgery, defined by the absence of surgical site infection (SSI), reoperation or recurrence
研究概览
简要总结
TIGER is a multicentre, 2-arm, parallel group, assessor blinded, non-inferiority randomised controlled trial with an internal pilot to assess if non-surgeon physicians (NSPs) can effectively perform mesh inguinal hernia repair compared to fully trained surgeons in adult patients with non-complicated inguinal hernia.
详细描述
Adult patients (18 years old to 60 years old, men and women) with non-complicated inguinal hernias suitable for elective repair will be recruited from at least 18 representative district hospitals in Low- and Middle-Income countries. Before and during a district hospital visit by a senior surgeon (at least once a year), a call will be made to the community, as is current practice (e.g., leaflet, radio, verbal at mosques, churches, market places, etc.).
Patients will attend the local district hospital on specific dates, which are contained within the announcement. A fully trained surgeon will examine the patient and identify patients according to the eligibility criteria, and if confirmed as eligible, they will be invited to enter the trial and consent obtained. If patients are not eligible for the trial, their care will follow the usual pathways.
After patient eligibility has been confirmed and informed consent has been obtained, patients will be randomised into the TIGER trial by a member of the TIGER research team at the site. Patients will be randomised to an operating list: NSP or surgeon list. The operating lists will be performed at the same hospital where the patient is randomised.
Patients are randomised to either of the following:
Intervention: Mesh inguinal hernia repair performed by Non-Surgeon Physicians (NSP) through an accredited training programme prior to commencing participation in the study.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- Single (Outcomes Assessor)
盲法说明
The primary outcome assessment 90 days after surgery will be performed by a trained member of the research team who will not have access to the patient's hospital records or notes. If additional data needs to be retrospectively retrieved from hospital notes relating to a patient's secondary outcomes, then this may be accessed by any member of the research staff at that hospital (blinded or unblinded).
The operating surgeon and patient are impossible to blind, as the patient will meet the surgeon on the day of surgery and introduce themselves. It is unethical and impractical not to tell a patient who is doing their surgery.
入排标准
- 年龄范围
- 18 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients older than <18 years> (male or female) and less or equal to 60 years
- •Primary inguinal hernia (unilateral) eligible for elective inguinal hernia repair
- •Primary bilateral, but only one side being repaired
- •Written informed consent of patient (signature or a fingerprint)
排除标准
- •Complex inguinal hernias: recurrent, obstructive, or femoral hernias
- •Bilateral inguinal hernias undergoing simultaneous repair
- •Inguinal hernias needing emergent surgical repair (e.g., incarcerated)
- •Patient unable to complete post-operative follow-up
研究组 & 干预措施
Non-Surgeon Physician
The intervention arm is a mesh inguinal hernia repair performed by a non-surgeon physician (NSP). These are medical officers who have finished a 2-year mandatory house job. The medical officers will be trained to perform inguinal hernia repair by a certified surgical trainer in Ghana.
干预措施: Mesh inguinal hernia repair performed by Non-Surgeon Physicians (NSP) (Other)
Control: Surgeon
The control is a mesh inguinal hernia repair performed by a fully trained surgeon, defined as one who is accredited as fully trained with the Ghana College of Physicians and Surgeons, West African College of Surgeons, or equivalent. A trained surgeon will be assisted by an NSP who has completed the TIGER training programme. We anticipate that at least 5-10 fully trained surgeons will take part in the control arm.
干预措施: Mesh inguinal hernia repair performed by fully trained surgeons (Other)
结局指标
主要结局
Safety 90 days after surgery, defined by the absence of surgical site infection (SSI), reoperation or recurrence
时间窗: 90 days post-op
SSI will be defined as per CDC criteria within 90 days of inguinal hernia repair SSI after surgery will be defined according to CDC criteria. The following CDC definition will be used to identify deep incisional or superficial SSIs: Infection must occur within 30-days of the index operation AND Infection must involve the skin, subcutaneous, muscular or fascial layers of the incision AND Patient must have at least one of the following: Purulent drainage from the wound Organisms detected from a wound swab Wound opened spontaneously or by a clinician AND, at the surgical wound, the patient has at least one of: pain or tenderness; localised swelling; redness; heat; systemic fever (\>38°C) Diagnosis of SSI by a clinician or radiological imaging Reoperation will be defined as any surgical complication requiring reoperation in theatre within 90 days of inguinal hernia repair. Recurrence will be defined as in the Reinforcement of Closure of Stoma Site (ROCSS) Trial.
次要结局
- Recurrence(90 days and 1 year after surgery)
- Chronic postoperative inguinal pain after surgery using the Faces Pain Scale - Revised (FPS-R) score(90 days and 1 year after surgery)
- Reoperation(30 and 90 days after surgery)
- Surgical site infection(30 and 90 days after surgery)
- Postoperative inguinal pain after surgery using the Faces Pain Scale - Revised (FPS-R) score(30 days after surgery)
- Duration of surgery(Measured intraoperatively)
- Senior assistance during the surgical procedure.(Measured intraoperatively)
- Costs of all treatment(30 days after surgery)
- Quality of life (assessed using Abdominal Hernia-Q)(1 year after surgery)
- Mortality(Within 30 days after surgery)