Small Bite Technique Versus Standardised Large Bites Technique in Closure of Midline Laparotomies: Randomised Control Trial.
试验速览
- 阶段
- 不适用
- 入组人数
- 108
- 主要终点
- Assessment of pain severity postoperative by pain scale
研究概览
简要总结
In the attempt to gain quick and complete access to the abdominal regions with the least damage to the nerves and the vascular structures, surgeons use the median laparotomy more frequently. However, postoperative complications such as incisional hernia continue to be the known leading complications after median laparotomy. The reported cases to range from 2 to 20%. Higher cases have also been reported with up to 35% in the absence and aortic patients. Recent statistics have showed that small tissue bites prevent incisional hernia can occur in the aponeurosis. This technique is more effective than the commonly used process, which involves large edges of mass closure. In this study investigators aim to compare small bites sutures in closure of laparotomy incision and standardized large bites sutures, and its affect in reducing the incidence of incisional hernia postoperative along with the surgical site infection.
the investigators hypothesize that the small bites technique will result in a significant reduction of the incidence of incisional hernia and optimize the surgical site infection in major surgeries which may lead to a reduced morbidity and a better quality of life for patients and a significant reduction of costs.
详细描述
Incisional hernia carries with life-threatening conditions such as the incarceration of bowel strangulation. However, incisional hernia remains the most common complication after median laparotomy, with reported incidences varying between 2-20%. Even higher incidences up to 30-35% have been reported in obese and aortic aneurysm patients. Incisional hernia also causes life impairment and discomfort. Median laparotomy and the incisional hernia have been under investigation for quite some time, and information about patients' risk factors and suture materials has been identified. However, the risk factors associated with suture techniques are not yet thoroughly investigated. Many clinical tests and analyses have concluded that a mass closure technique involving a simple running suture is the most effective way to prevent incisional hernia and close a midline incision. The method is also easy and fast to perform compared to other layered methods involving interrupted sutures. Use of natural materials that are thin resorbable materials decreases the occurrence of the incisional hernial and lower the intensity of preoperative pain and wound infections compared to the use of suture materials that are non-resorbable.
In this study the investigators aim to compare the small bites technique with a standardised large bites technique:
- Primary outcome:
- Incidence of Incisional Hernia postoperative.
- Pain scale.
- Secondary outcome:
- Quality of life, recovery, return to usual activity.
- Surgical site infection
- Time for closure.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Double (Participant, Outcomes Assessor)
盲法说明
Double blinded. (patients and research recruiter)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Laparotomy through a midline incision
- •Age more than 18
排除标准
- •Previous incisional hernia or fascial dehiscence with secondary healing after a midline incision.
- •Abdominal surgery through a midline incision within the last three months.
- •Patient on steroids and with genetic anomalies.
- •Malignancy patients, next exposed to radiation therapy.
结局指标
主要结局
Assessment of pain severity postoperative by pain scale
时间窗: Day 14 postoperative
Assessment of pain scale post operative, lower score mean a better outcome.
Incidence of Incisional Hernia postoperative
时间窗: Follow up on 1 year postoperative.
Incidence of Incisional Hernia postoperative, will be assessed by using Ultra Sound.
次要结局
- Surgical site infection of the wound postoperative(day 14 postoprtaive.)
- Assessment of early mobilisation(Postoperative period, assessment in day3.)
- Retain to work (how many days between surgery and patient back to his work)(up to 6 weeks, postoperative period from discharge until day patient back to work.)
- Time taken in closure of laparotomy incision (in minutes)(intraoperative (through the closure of the laparotomy incision inside the operation room, suturing time (start to end) in minutes . (how many minutes surgeon took in suturing the incision)))
研究者
Nasser Mohamed Amer
Assistant professor of General Surgery in Imam Abdulrahman bin Faisal University
Imam Abdulrahman Bin Faisal University