Postoperative Pain and Quality of Life With Different Modalities of Mesh Fixation in Laparoscopic Trans-Abdominal Pre-Peritoneal Repair of Inguinal Hernia. A Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 75
- 试验地点
- 1
- 主要终点
- Postoperative Pain Intensity
研究概览
简要总结
This study is a clinical trial that aims to compare three different methods for securing a surgical mesh during a specific type of groin (inguinal) hernia repair surgery. The surgery is performed using a minimally invasive, keyhole technique called TAPP.
The main questions this study aims to answer are:
Which mesh fixation method-surgical glue, stitches (sutures), or small metal coils (tacks)-results in less pain for patients after surgery?
Which method leads to a better quality of life and less feeling of the mesh inside the body after recovery?
Is there a difference in how long the surgery takes with each method?
To answer these questions, researchers will compare the three methods to see which one works best for patient comfort and recovery.
Adults aged 21-60 years with a new inguinal hernia who are having laparoscopic TAPP surgery can participate.
Participants will be randomly assigned to one of three groups:
Group 1: Their mesh will be secured using surgical glue.
Group 2: Their mesh will be secured using stitches (sutures).
Group 3: Their mesh will be secured using small metal coils (tacks).
All other parts of the surgery and care after surgery will be the same.
Participants will:
Have the laparoscopic TAPP hernia repair surgery.
Report their pain levels after surgery using a simple scale.
Answer questions about their comfort and quality of life during follow-up visits at 1, 3, and 6 months after surgery.
详细描述
This study is a prospective, single-center, randomized controlled trial designed to compare the postoperative outcomes associated with three distinct mesh fixation modalities in laparoscopic Trans-Abdominal Pre-Peritoneal (TAPP) inguinal hernia repair.
Scientific Rationale:
While mesh reinforcement has drastically reduced recurrence rates in hernia surgery, chronic postoperative pain and mesh-related discomfort remain significant concerns that impact patient quality of life. The method of securing the mesh is hypothesized to be a key factor influencing these outcomes. Mechanical fixation with tacks or sutures may cause tissue trauma or nerve irritation, whereas adhesive fixation provides an atraumatic alternative. Direct comparative data on these three common techniques(glue, sutures, and tacks) within the standardized TAPP procedure is limited.
Study Design:
A total of 75 eligible participants will be enrolled and equally randomized into one of three parallel intervention arms in a 1:1:1 ratio. The randomization sequence will be computer-generated. Due to the nature of the interventions, blinding of the surgeon is not feasible; however, outcome assessors and the statistician will be blinded to group assignment where possible.
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
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 21 Years 至 60 Years（Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •Adults aged 21 to 60 years
- •Diagnosis of primary (de novo) inguinal hernia
- •Hernia type: unilateral or bilateral, direct or indirect
- •Scheduled for elective laparoscopic transabdominal preperitoneal (TAPP) repair
- •Able to provide informed consent
排除标准
- •Age <21 or >60 years
- •Recurrent inguinal hernia
- •Complicated hernia (irreducible, incarcerated, obstructed, or strangulated)
- •Contraindication to laparoscopic surgery or general anesthesia
- •Significant comorbid conditions making surgery high-risk (ASA class ≥III)
- •Chronic pain syndrome or regular use of strong analgesics
- •Allergy to mesh materials (polypropylene) or fixation components (cyanoacrylate, titanium)
- •Participation in another clinical trial
- •Inability to complete follow-up or comply with study protocol
研究组 & 干预措施
Glue Mesh Fixation
Participants in this arm will undergo laparoscopic transabdominal preperitoneal (TAPP) inguinal hernia repair with mesh fixation using a cyanoacrylate-based surgical adhesive (Glubran-2®) applied via a dedicated applicator (GlueTack device). The mesh will be secured with small drops of glue at its corners.
干预措施: Cyanoacrylate Surgical Adhesive Fixation (Device)
Glue Mesh Fixation
Participants in this arm will undergo laparoscopic transabdominal preperitoneal (TAPP) inguinal hernia repair with mesh fixation using a cyanoacrylate-based surgical adhesive (Glubran-2®) applied via a dedicated applicator (GlueTack device). The mesh will be secured with small drops of glue at its corners.
干预措施: Laparoscopic Transabdominal Preperitoneal (TAPP) Inguinal Hernia Repair with Polypropylene Mesh Fixation. . (Procedure)
Suture Mesh Fixation
Participants in this arm will undergo laparoscopic transabdominal preperitoneal (TAPP) inguinal hernia repair with mesh fixation using two non-absorbable polypropylene sutures placed at the medial and lateral ends of the mesh. This is a traditional mechanical fixation method.
干预措施: Suture Mesh Fixation (Procedure)
Suture Mesh Fixation
Participants in this arm will undergo laparoscopic transabdominal preperitoneal (TAPP) inguinal hernia repair with mesh fixation using two non-absorbable polypropylene sutures placed at the medial and lateral ends of the mesh. This is a traditional mechanical fixation method.
干预措施: Laparoscopic Transabdominal Preperitoneal (TAPP) Inguinal Hernia Repair with Polypropylene Mesh Fixation. . (Procedure)
Tack Mesh Fixation
Participants in this arm will undergo laparoscopic transabdominal preperitoneal (TAPP) inguinal hernia repair with mesh fixation using helical titanium tacks (e.g., ProTack®). This is a standard mechanical fixation method commonly used in laparoscopic hernia repair. Tacks are placed around the periphery of the mesh, avoiding critical neurovascular zones.
干预措施: Helical Titanium Tack Fixation (Device)
Tack Mesh Fixation
Participants in this arm will undergo laparoscopic transabdominal preperitoneal (TAPP) inguinal hernia repair with mesh fixation using helical titanium tacks (e.g., ProTack®). This is a standard mechanical fixation method commonly used in laparoscopic hernia repair. Tacks are placed around the periphery of the mesh, avoiding critical neurovascular zones.
干预措施: Laparoscopic Transabdominal Preperitoneal (TAPP) Inguinal Hernia Repair with Polypropylene Mesh Fixation. . (Procedure)
结局指标
主要结局
Postoperative Pain Intensity
时间窗: Assessed on postoperative Day 1 and at 1 month, 3 months, and 6 months postoperatively.
Intensity of pain measured using the Visual Analogue Scale (VAS), a 10-point scale where 0 = no pain and 10 = worst pain imaginable.
Postoperative Quality of Life and Mesh Sensation
时间窗: Assessed at 1 month, 3 months, and 6 months postoperatively.
Patient-reported quality of life and mesh-related symptoms were measured using the Carolinas Comfort Scale (CCS), a validated hernia-specific outcome measure. The CCS consists of 23 items evaluating pain, mesh sensation, and movement limitation during daily activities, each scored from 0 (no symptoms) to 5 (disabling symptoms), yielding a total score range of 0-115. Higher scores indicate worse postoperative comfort and quality of life.
Operative Time
时间窗: Recorded on the day of surgery.
Total duration of surgery, measured from skin incision to skin closure (in minutes).
次要结局
- Hernia Recurrence(Assessed at 6 months postoperatively.)
- Time to Return to Work/Normal Activity(Assessed within the first 4 weeks postoperatively.)
- Length of Hospital Stay(Measured during the immediate postoperative period (typically 1-2 days).)
- Postoperative Complications(Assessed on postoperative Day 1 and at 1 month, 3 months, and 6 months postoperatively)
- Direct Material Cost of Mesh Fixation Device(Recorded on the day of surgery.)
研究者
Ahmed Eid Ali Ahmed Aziz
Lecturer
Cairo University