Efficacy of Barbed versus Polyglactin 910 for Vault closure in Total Laparoscopic Hysterectomy in a Tertiary care center in South India - A Randomized Controlled Trial
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
- Time taken for closure of vault intracorporealy between barbed and polyglactin 910 in total laparoscopic hysterectomy
研究概览
简要总结
Hysterectomy is the surgical removal of uterus done for benign and malignant gynaecological conditions. Hysterectomy is performed by various approaches viz. Abdominal hysterectomy (AH), Vaginal hysterectomy (VH), Laparoscopic assisted Vaginal hysterectomy (LAVH), Laparoscopic hysterectomy (LH(a)), Total Laparoscopic hysterectomy (TLH), Robotic assisted hysterectomy (RH) and Single-port Laparoscopic hysterectomy (SP-LH) & Mini-Laparoscopic hysterectomy (mini-LH).
Total Laparoscopic Hysterectomy is the procedure where the entire operation is performed laparoscopically including suturing of the vaginal vault and there is no vaginal component except for the removal of the uterus. It requires higher degree of laparoscopic surgical skill. A new challenge in minimally invasive laparoscopic surgeries is the ability to quickly and properly tie the surgical knots. In TLH, the vaginal cuff closure is the technically difficult part and improper closure can lead to vault dehiscence. Minimally invasive procedures seem to increase the risk of vaginal cuff dehiscence (VCD). Vaginal vault closure in laparoscopic hysterectomy is performed by various techniques and using various suture materials viz. vault closure vaginally or intracorporeally, using barbed or vicryl sutures, unidirectional or bidirectional barbed sutures, suturing with interrupted / running / figure of 8 sutures.
Barbed suture is a new class of suture introduced to aid surgeons during laparoscopic suturing, with the aim to reduce operative time, blood loss, and vaginal dehiscence. Barbed sutures are different from the conventional sutures as barbed sutures do not require a knot placement and the barbs present in the suture material act as self-retaining points at regular intervals along the suture that makes the technique knotless and distributes the tension equally in the tissue. The surgical knot reduces the tensile strength of the suture by thinning and stretching the suture. This intrinsic disadvantage of any suture is avoided by barbed sutures. These sutures also reduce the operating time by eliminating the need for placement of knots which is the technically challenging task in intracorporal suturing of laparoscopic surgeries.
This study compares Polyglactin 910 and Barbed suture used for vault closure intracorporeally in Total Laparoscopic Hysterectomy. The former need knotting and the latter does not need knotting, thus the latter helps in saving time and brings about surgical ease while operating especially for a beginner in laparoscopic surgeries. But we need evidence to establish that one suture is superior over the other including the overall outcome like the incidence of postoperative complications, postoperative pain, quality of life, cost of material, time saved, surgical ease, etc. In India, only less number of studies are available comparing these to sutures for vault closure. This study uses a reliable methodology - Randomized Controlled Trial and the conclusion of the trial will add evidence to the existing literature and useful for surgical practice in future.
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
- 40.00 Year(s) 至 75.00 Year(s)(—)
- 性别
- Female
入选标准
- •All women undergoing total laparoscopic hysterectomy for benign gynaecological conditions, who are willing for the study.
排除标准
- •Women with gynaecological malignancies
- •Immunocompromised patients
- •Morbidly obese patients
- •Unfit for surgery due to general condition
- •Participants not consenting for study.
结局指标
主要结局
Time taken for closure of vault intracorporealy between barbed and polyglactin 910 in total laparoscopic hysterectomy
时间窗: Baseline
次要结局
- Incidence of Post Operative complications between Barbed suture & Polyglactin 910 like(1 surgical site infection (vault))
- Surgical difficulty in vault closure between Barbed & Polyglactin 910 assessed using Visual Analogue Scale (VAS)(Baseline)
- Post operative pain between Barbed & Polyglactin 910 assessed using Visual Analogue Scale (VAS)(24 hours & Day 3)
- Cost difference between Barbed & Polyglactin 910(Baseline)
研究者
Dr Balaji Shri Vishnu V
Southern Railway Headquarters Hospital, Chennai
