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临床试验/CTRI/2024/05/066985
CTRI/2024/05/066985尚未招募4 期

COMPARISION OF POLYGALACTIN 910 WITH BARBED SUTURES FOR VAGINAL CUFF CLOSURE IN TOTAL LAPROSCOPIC HYSTERECTOMY

Adichunchanagiri Institute Of Medical Sciences1 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2024年5月20日最近更新:

试验速览

阶段
4 期
状态
尚未招募
发起方
入组人数
60
试验地点
1
主要终点
To compare vault closure time during total laparoscopic hysterectomy using unidirectional barbed suture with polyglactin 910 suture

研究概览

简要总结

Hysterectomy is one of the very commonly performed gynecological procedures. In the recent times a shift is seen in preference of laparoscopic hysterectomies over laparotomy. Laparoscopy has several important advantages over laparotomy, which include less pain, reduced recovery time, shorter hospital stay, and avoidance of a large operative scar[1]. Laparoscopic hysterectomy has been reported to have higher rates of vaginal complications including vaginal cuff dehiscence compared to open surgery. Laparoscopic colpotomies using electrosurgical devices likely cause more tissue necrosis and devascularization owing to higher vaginal complications. Laparoscopic hysterectomy is also associated technical difficulty and long learning curve, that might add to the complications rate. Laparoscopic suturing of the vaginal cuff and knotting is the most challenging step in total laparoscopic hysterectomy (TLH) and requires surgical skill. In TLH, the vaginal cuff can be sutured laparoscopically (either intracorporeal or extracorporeal) and vaginally[2].  Endoscopic suturing with knotting increases the time of surgery considerably[3].

The barbed suture is a relatively newer suture material. It is being used for closure in laparoscopic surgeries. The haemostatic properties and ease of use has made barbed sutures (Trubarb) a preferred mode of closure. Currently polyglactin 910 (Trusynth) is widely used for closure of vaginal cuff, by continuous interlocking suturing and knotting for the closure of vaginal cuff in total laparoscopic hysterectomies.

研究设计

研究类型
Interventional
分配方式
Na
盲法
None

入排标准

年龄范围
30.00 Year(s) 至 75.00 Year(s)(—)
性别
Female

入选标准

  • Patients undergoing total laparoscopic hysterectomy
  • Abnormal uterine bleeding
  • Chronic PID
  • Age more than 30 years
  • Those who have given informed consent.

排除标准

  • Age less than 30 years
  • Those undergoing total abdominal hysterectomy
  • Those undergoing vaginal hysterectomy
  • Patients with malignancy
  • Patients with coagulation disorder 6.

结局指标

主要结局

To compare vault closure time during total laparoscopic hysterectomy using unidirectional barbed suture with polyglactin 910 suture

时间窗: Baseline Day of surgery

次要结局

  • To evaluate total operative time from first incision till closure(Day of surgery)
  • To evaluate post operative pain using 10 point Visual Analog Scale score(Day of surgery post-surgery day 2 day of discharge post surgery day 7 post surgery day 21)
  • To evaluate intraoperative handling property of both the suture using Product Usage Assessment Scale(Day of surgery)
  • To assess the length of hospital stay(Day of surgery till day of discharge)
  • To assess vaginal cuff related complications(Day of surgery post-surgery day 2 day of discharge post surgery day 7 post surgery day 21)

研究者

发起方
Adichunchanagiri Institute Of Medical Sciences
申办方类型
Private medical college
责任方
Principal Investigator
主要研究者

Dr PREETHI MASKI

Adichunchanagiri Institute Of Medical Sciences, B.G. Nagara

研究点 (1)

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