The Use of Local Hemostatic in Patients With Large Incisional Hernias: Randomized Controlled Trial Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 66
- 试验地点
- 2
- 主要终点
- drainage duration
研究概览
简要总结
Design of a simple blind randomized controlled trial study. Large incisional hernia repair with use of local hemostatic Hemoblock
详细描述
Design of a simple blind randomized controlled trial study. The total number of subjects was 66. In the main group (A) - 33, in the other group (B) - 33. Operation - sublay retromuscular using prolene mesh implant. In group A Hemoblock 15 ml in the retromuscular and 15 ml in the subcutaneous spaces were used. Wounds were drained by vacuum-suction drainage. Postoperative monitoring of early ultrasound examinations on the 3rd, 7th, 10th, 12th, 15th, 18th, 21st, 25th, 28th, 30th days after drainage removal.
In group B were used a standard intervention (sublay retromuscular).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Sequential
- 主要目的
- Prevention
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 25 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •ASA I, II, III
- •the absence of oncological pathology
- •consent to participate in the study
- •Large incisional hernia (hernial defect ≥10 cm in diameter and/or area of hernial defect ≥100 cm2) according to the classification of EHS, 2009 (W3); age 25-75 years
排除标准
- •age older than 75 years
- •decompensated concomitant pathology, ASA≥IV
- •patient refusal to participate in the study
结局指标
主要结局
drainage duration
时间窗: from 1 to 6 days after operation
Duration of drainage in days
the amount of C-RP in exudate from post-op wound
时间窗: from 1 to 6 days after operation
The number of C-RP
the ultrasound changes of fluid collections in the postoperative wound
时间窗: on the 3rd, 7th, 10th, 12th, 15th, 18th, 21st, 25th, 28th, 30th days after drainage removal.
volume of the fluid collections in the post-op wound after drains removal
the number of lymphocytes in exudate from post-op wound
时间窗: from 1 to 6 days after operation
The number of lymphocytes
the amount of the exudate from post-op wound
时间窗: from 1 to 6 days after operation
How many ml is exudate from the wound
the number of necessary punctures of the postoperative wound
时间窗: up to 30 days after drains removal
How many punctures need to treatment fluid collections
amount of seromas
时间窗: up to 30 days after drains removal
use Morales-Conde classification
other postoperative wound complications
时间窗: up to 30 days after drains removal
such as SSI, thromboembolism, therapeutic complications
white blood cell count in exudate from post-op wound
时间窗: from 1 to 6 days after operation
The number of leukocytes
the amount of Albuminum in exudate from post-op wound
时间窗: from 1 to 6 days after operation
The number of Albuminum
次要结局
- The concentration of NSAD in mg of applied analgesics(up to 7-10 days after surgery)
- Lenght of the Hospital stay(from 4 to 18 days)
- The concentration of Tramadol in mg of applied analgesics(up to 7-10 days after surgery)
- The concentration of Trimeperidine in mg of applied analgesics(up to 7-10 days after surgery)
- Duration of use NSAD in days(up to 7-10 days after surgery)
- post-operative pain scores using numerical rating on Visual Analogue Scale (VAS)(Ten days after surgery twice a day (at 06:00 AM and at 06:00 PM).)
- Duration of use Trimeperidine in days(up to 7-10 days after surgery)
- Duration of use Tramadol in days(up to 7-10 days after surgery)