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临床试验/NCT07379411
NCT07379411招募中不适用

Energy-based Opportunistic Salpingo-oophorectomy During Vaginal Hysterectomy - is it Better Than Conventional "Knot-and-cut" Approach? A Randomized Controlled Study

Wolfson Medical Center1 个研究点 分布在 1 个国家目标入组 70 人开始时间: 2025年10月16日最近更新:
干预措施

试验速览

阶段
不适用
状态
招募中
入组人数
70
试验地点
1
主要终点
Duration of salpingo-oophorectomy procedure

研究概览

简要总结

This study compares two methods for removing the fallopian tubes and ovaries during vaginal hysterectomy for pelvic organ prolapse.

One method uses an energy-based surgical device called LigaSure Maryland, which seals blood vessels using electrical energy. The other method is the standard surgical approach, which involves clamping, cutting, and suturing the tissue. The purpose of the study is to determine whether the use of the LigaSure device is as safe as, or more effective than, the standard technique, in terms of procedure duration, blood loss, postoperative pain, length of hospital stay, and complication rates.

Women who are scheduled to undergo vaginal hysterectomy for pelvic organ prolapse and for whom removal of the fallopian tubes and ovaries is recommended may participate in the study. Participants will be randomly assigned to one of two groups, receiving either the LigaSure technique or the standard surgical technique.

The decision to perform removal of the fallopian tubes and ovaries will be made before surgery based on standard medical indications. Participants will not be informed which surgical technique is used during their operation. Surgical outcomes between the two groups will be compared to evaluate safety and effectiveness.

详细描述

Vaginal hysterectomy is a common surgical procedure performed for benign gynecologic indications, including pelvic organ prolapse. Opportunistic salpingectomy, with or without oophorectomy, is increasingly recommended at the time of hysterectomy in women at average risk for ovarian cancer, as it may reduce future cancer risk without increasing surgical morbidity. During vaginal hysterectomy, salpingo-oophorectomy can be performed using a conventional surgical technique involving clamping, cutting, and suturing, or by using energy-based vessel sealing devices.

Energy-based devices, such as the LigaSure Maryland, have been shown in other gynecologic procedures to reduce operative time, blood loss, and length of hospital stay. However, there are limited data comparing energy-based versus conventional techniques specifically for opportunistic salpingo-oophorectomy performed during vaginal hysterectomy.

This prospective, randomized controlled study is designed to compare an energy-based technique using the LigaSure Maryland device with a standard "knot-and-cut" technique for opportunistic salpingo-oophorectomy during vaginal hysterectomy for benign indications.

Women scheduled to undergo vaginal hysterectomy for pelvic organ prolapse, for whom salpingo-oophorectomy is recommended according to standard clinical indications, will be eligible for participation. After providing informed consent, participants will be randomly assigned to one of two parallel groups. In the intervention group, salpingo-oophorectomy will be performed using the LigaSure Maryland energy-based vessel sealing device. In the control group, salpingo-oophorectomy will be performed using the standard surgical technique of clamping, cutting, and suturing.

Randomization will be performed prior to surgery using a computerized randomization tool. Participants will be blinded to the surgical technique used. Surgeons will not be blinded due to the nature of the interventions.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Single (Participant)

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
Female
接受健康志愿者

入选标准

  • Women aged 18 years or older.
  • Scheduled to undergo vaginal hysterectomy for pelvic organ prolapse.
  • Recommended to undergo opportunistic salpingo-oophorectomy according to standard clinical indications.
  • Able and willing to provide written informed consent.

排除标准

  • Suspected or known pelvic malignancy.
  • Lack of informed consent.
  • Planned opportunistic salpingo-oophorectomy using a non-vaginal surgical approach.
  • Planned opportunistic salpingo-oophorectomy using a vNOTES (vaginal natural orifice transluminal endoscopic surgery) approach.
  • Intraoperative need to deviate from the assigned surgical technique due to anatomical or technical considerations.

研究组 & 干预措施

Standard Technique group

Active Comparator

Salpingo-oophorectomy performed using the standard surgical technique of clamping, cutting, and suturing during vaginal hysterectomy.

干预措施: Standard salpingo-oophorectomy technique (Procedure)

LigaSure Maryland group

Experimental

Salpingo-oophorectomy performed using the LigaSure Maryland energy-based vessel sealing device during vaginal hysterectomy

干预措施: LigaSure MaryLand (Device)

结局指标

主要结局

Duration of salpingo-oophorectomy procedure

时间窗: From completion of vaginal hysterectomy until completion of salpingo-oophorectomy, assessed over approximately 5-30 minutes during surgery

Duration of the salpingo-oophorectomy procedure, measured from completion of the vaginal hysterectomy and the decision to proceed with salpingo-oophorectomy until removal of the fallopian tube and ovary specimen from the patient on the both sides.

次要结局

  • Intraoperative blood loss(From completion of vaginal hysterectomy until completion of salpingo-oophorectomy, assessed over approximately 5-30 minutes during surgery)
  • Postoperative pain(Within 24 hours after surgery)
  • Length of hospital stay(From admission to the gynecology ward after surgery until hospital discharge, assessed over approximately 1-5 days)
  • Intraoperative and postoperative complications(From surgery to 30 days after surgery)

研究者

申办方类型
Other Gov
责任方
Principal Investigator
主要研究者

Michael Babin

Principal Investigator

Wolfson Medical Center

研究点 (1)

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