跳至主要内容
临床试验/NCT05623514
NCT05623514招募中不适用

Pre-surgical Ultrasound Evaluation for Improving Patient Selection for vNOTES Approach

The University of Texas Health Science Center, Houston1 个研究点 分布在 1 个国家目标入组 75 人开始时间: 2022年5月16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
75
试验地点
1
主要终点
The rate of adhesions/ complicated entry to the Douglas space reported during surgery.

研究概览

简要总结

Vaginal Natural Orifice Transluminal Endoscopic Surgery (vNOTES) is an emerging field in minimally invasive surgery. International consensus-based statement was recently published to help guide the basis for adopting vNOTES into clinical practice, including regarding patient selection. It was agreed that women with potential adhesions are not appropriate candidates for vNOTES approach including women with suspected adhesions due to history of severe pelvic inflammatory disease (PID) or endometriosis. However, as some pelvic infections might be asymptomatic, pre-operation imaging might be beneficial to complete improved selection of patients. Moreover, women with previous severe PID or endometriosis might still have favorable pelvic to perform the vNOTES approach. Therefore, we aim to compare pre-operation ultrasound evaluation to operative characteristics and outcomes in women undergoing VNOTES approach surgery.

详细描述

Vaginal Natural Orifice Transluminal Endoscopic Surgery (vNOTES) is an emerging field in minimally invasive surgery. It has gained the most popularity compared to other transluminal natural orifices such as mouth, rectum or urinary tract. By incorporating the advantages of endoscopic surgery, the vNOTES approach avoids abdominal wall wounds and trocar-related complications. Recent studies report reduced postoperative pain, accelerated postoperative recovery, and decreased postoperative wound infections, as well as achieving highly satisfying cosmetic results. All these made this technique very appealing to surgeons and patients alike.

The feasibility and safety of vNOTES in gynecologic surgeries, was first introduced by Ahn et al. in 2012 that performed vNOTES in ten women with benign uterine adnexal disease. Since then, surgeons have developed the technique in various benign gynecologic surgeries indications. There has been an exponential uptake of the number of surgeons performing vNOTES procedures worldwide with no official guidance to ensure the safe implementation of this technique into gynecological practice. The novelty of the technique is still a matter of concern in sub-populations and different indications.

International consensus-based statement was recently published based on Delphi consensus of expert panel to help guide the basis for adopting vNOTES into clinical practice with respect to eight key domains including patient selection. It was agreed that women with potential adhesions are not appropriate candidates for vNOTES approach including women with a history of a severe PID that is considered contraindication. 97.4% of the experts agreed that it is not necessary to perform a preoperative vaginal culture if the patient is asymptomatic. However, as some pelvic infections might be asymptomatic such as with chlamydia, pre-operation imaging might be beneficial to complete proper patient selection for the vNOTES approach. Moreover, women with previous severe PID infection might still have favorable pelvic to perform the vNOTES approach Aim: To the best of our knowledge no guidelines have been published regarding the pre-operation evaluation and the imaging characteristics. Due to the aforementioned, the aim of our study is to compare pre-operation ultrasound evaluation to operative characteristics and outcomes.

Material and Methods This is a prospective cohort study that will be conducted in a single tertiary medical center. Study population will include all women planned for surgery due to benign indication (adnexectomy/ hysterectomy) that vNOTES approach is considered and have normal vaginal examination (normal mobility of the uterus). Women with history of pelvic radiation, suspected malignancy or combined operations will be excluded from the study.

Intervention:

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Diagnostic
盲法
None

入排标准

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

入选标准

  • •Women planned to undergo surgery for hysterectomy or adnexal indication with normal vaginal examination, that are considered for vNOTES approach.

排除标准

  • •History of radiation to the pelvis
  • •Malignancy
  • •Combined current vaginal operation (for the treatment of prolapse/ urinary complaints)

研究组 & 干预措施

Candidates for vaginal natural orifice trans-luminal surgery approach

Experimental

Candidates for benign gynecological surgery in the vaginal natural orifice trans-luminal surgery approach

干预措施: Trans-vaginal ultrasound (Combination Product)

结局指标

主要结局

The rate of adhesions/ complicated entry to the Douglas space reported during surgery.

时间窗: From recruitment in the clinics until one month post operation

次要结局

  • Organ damage(From operation until one month post-operation)

研究者

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

Aya Mohr Sasson

Principle investigator

The University of Texas Health Science Center, Houston

研究点 (1)

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