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临床试验/NCT06315582
NCT06315582招募中不适用

Surgical Approach to Uterine Septum: A Randomized Controlled Trial

Northwestern University2 个研究点 分布在 1 个国家目标入组 40 人开始时间: 2024年3月11日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
招募中
入组人数
40
试验地点
2
主要终点
Procedure-level variables: operative time hysteroscopic septoplasty

研究概览

简要总结

The objective of this study is to determine if the use of scissors without electrosurgery is superior to bipolar electrosurgery for resection of uterine septum. The investigators will be comparing procedure-level variables such as operative time, complications, and need for additional procedures.

详细描述

This study is being done to compare two different surgical techniques that can be used to remove the uterine septum. At Northwestern, both procedures are done routinely. Surgeon preference and comfort dictates which is offered. Both techniques are thought to achieve the same goal of removing the participants septum with a procedure called a hysteroscopy in which the participants are taken to the operating room and a scope with a camera is inserted inside their uterus while it is expanded with sterile water. The difference is the instrument used to remove the septum. One technique uses scissors without electricity or heat followed by removal of the excess tissue with a thin tube using suction. The other technique uses an electrical loop (electrosurgery) to cut and remove the tissue. The investigators will be comparing these two procedures by measuring things such as operative time, cost, and the amount of fluid (saline) the participants body absorbs. As mentioned above, to visualize the inside of the participants uterus, the investigators will expand it by filling it with saline.Some of this fluid is absorbed by the walls of the uterus and is routinely measured. This will be one of the measurements used to compare the two surgical techniques.

About 4 weeks after the participants procedure they will have a routine follow up visit to determine if there is any septum left. The investigators will do this by doing an in-office hysteroscopy at this appointment. This might be a simple vaginal ultrasound, ultrasound with saline or a follow up hysteroscopy. If there remains some septum, it would be removed during a second hysteroscopy. It is common to need a second or even third procedure to completely remove the septum. The investigators anticipate the two techniques being compared will have similar success rates in removing the uterine septum, although there is some data to suggest that the current standard of care procedure which is using electrosurgery could cause additional adhesive disease and require another procedure to remove the adhesions. Currently, there is little data comparing these two techniques and so this study will help us understand if one causes more adhesions or not.

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
Double (Participant, Care Provider)

盲法说明

Participants will be randomized using www.randomizer.org algorithm. They will be assigned to arm in the operating room where they will get that intervention. When they get to Post Anesthesia Care Unit, they will be unblinded. Surgeon will be blinded until patient is in operating room and envelope with randomization is opened.

入排标准

年龄范围
22 Years 至 44 Years(Adult)
性别
Female
接受健康志愿者

入选标准

  • Have a confirmed septum (>1.0 cm) confirmed with 3D imaging and/or MRI
  • 20-44 years old

排除标准

  • Known tubal disease
  • Bleeding diastasis
  • No blood thinners
  • No concurrent laparoscopy scheduled
  • Patient with confirmed fibroids over >1 cm FIGO (International Federation of Gynecology and Obstetrics) type 1

研究组 & 干预措施

Study Intervention A (control group)

Active Comparator

Hysteroscopic septoplasty utilizing bipolar electrosurgery

干预措施: Hysteroscopic septoplasty utilizing bipolar electrosurgery (Procedure)

Study Intervention B (study group)

Experimental

Hysteroscopic septoplasty utilizing scissors without electrosurgery followed by hysteroscopic morcellation of residual tissue

干预措施: Removal of uterine septum with hysteroscopic scissors without electrosurgery. (Procedure)

结局指标

主要结局

Procedure-level variables: operative time hysteroscopic septoplasty

时间窗: During the intervention/procedure/surgery

We will measure time it takes to conduct procedure

Procedure-level variables: Surgical Cost

时间窗: During the surgery

We will compare amount of money spent.

Procedure-level variables: Fluid deficit

时间窗: During the surgery

We will measure amount of fluid deficit which is a number that is generate by hysteroscope.

Resolution of uterine septum

时间窗: Assess at 4 weeks post-op hysteroscopy

Compare septum resolution defined by being less than 1 cm in depth from the intertubal line and need for additional intervention following hysteroscopic septoplasty utilizing these two surgical techniques

次要结局

  • Comparing patient recovery and satisfaction(2 days postop)
  • Compare adverse events(Immediate period-- 1 week post-operation)

研究者

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

Magdy Milad, MD

Chief of Minimally Invasive Gynecologic Surgery in the Department of Obstetrics and Gynecology at Northwestern University

Northwestern University

研究点 (2)

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