A RANDOMIZED CONTROL STUDY COMPARING THREE TYPES OF SKIN CLOSURE TECHNIQUES IN LAPAROSCOPIC SURGERY.
试验速览
- 阶段
- 2/3 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 180
- 试验地点
- 1
- 主要终点
- To review the wound cosmetologically under HWES (Hollander wound evaluation score) in different skin closure techniques.
研究概览
简要总结
The rationale for conducting a randomized controlled study comparing three types of skin closure
techniques in laparoscopic surgery stems from the necessity to optimize postoperative outcomes and
address patient concerns regarding recovery and cosmesis. Despite the advantages of laparoscopic
methods, such as reduced pain and quicker recovery times, the issue of incisional hernias and
unsatisfactory scar appearances remains a significant concern. These complications can lead to
extended recovery periods, additional surgeries, and dissatisfaction with the cosmetic outcomes, all of
which can affect the patient’s quality of life and increase healthcare costs. Current closure techniques
include traditional suturing, the use of adhesives, and metal staples, each with its own set of
advantages and potential drawbacks. For instance, sutures are versatile and widely used but can be
time-consuming and may cause more noticeable scarring. Adhesives provide a quick and less invasive
method that reduces scarring but might not offer the same level of strength and durability, particularly
in high-tension areas. Staples are fast and consistent but can be painful upon removal and may lead to
more prominent scars. This study aims to directly compare these three methods in a controlled setting
to provide empirical data on their efficacy, focusing on specific outcomes such as healing time,
incidence of herniation, pain levels, and cosmetic satisfaction.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- None
入排标准
- 年龄范围
- 18.00 Day(s) 至 75.00 Day(s)（—）
- 性别
- All
入选标准
- •Adult patients in the age group of 18 to 75 who are undergoing elective laparoscopic surgeries in whom umbilical port site is included and with no previous complications like infected cases or emergencies are included in this study.
排除标准
- •1.Patients who are included previously, in whom the laparoscopic port site is extended during intra operative period ,due to any particular cause are excluded from this study.
- •2.Patients who come on emergency basis and patients with infected intra abdominal solid organs are excluded from this study.
- •3.Patients who lost to follow up and patients who are not willing to give consent are not included in this study.
结局指标
主要结局
To review the wound cosmetologically under HWES (Hollander wound evaluation score) in different skin closure techniques.
时间窗: Day0 Day3 Day 7 to 10 Day 21 to 30
次要结局
- To assess complications of wound closure in different skin closure techiniques.(To evaluate inflammatory response of the wound pertaining to different)
研究者
Puli Karthik Reddy
Bharati Vidyapeeth(Deemed to be University), medical college, Pune, PIN:411043