Ultrasound Evaluation for Improving Patient Selection in vNOTES

NCT05623514 | Recruiting FDA Device

• 1 other identifier: HSC-MS-22-0947
• Study Type: interventional
• Target: 75
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Surgery

Keywords

vaginal surgery; trans-vaginal ultrasound examination; sliding sign

Outcome Measures

Primary Outcomes (1)

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

  From recruitment in the clinics until one month post operation

Secondary Outcomes (1)

• Organ damage

  From operation until one month post-operation

Study Arms (1)

Candidates for vaginal natural orifice trans-luminal surgery approach

EXPERIMENTAL

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

Combination Product: Trans-vaginal ultrasound

Interventions

Trans-vaginal ultrasound COMBINATION_PRODUCT

Pre-operative trans-vaginal ultrasound in order to evaluate sliding sign between the uterus and the rectum

Candidates for vaginal natural orifice trans-luminal surgery approach

Eligibility Criteria

• Age: 18 Years+
• Gender Eligibility Details: Inclusion criteria include only women undergoing vaginal surgery
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• The University of Texas Health Science Center, Houston: lead

Study Sites (1)

University of Texas

Houston, Texas, 77030, United States

RECRUITING

Related Publications (6)

• Jallad K, Walters MD. Natural Orifice Transluminal Endoscopic Surgery (NOTES) in Gynecology. Clin Obstet Gynecol. 2017 Jun;60(2):324-329. doi: 10.1097/GRF.0000000000000280.

  PMID: 28221179 RESULT

• Li CB, Hua KQ. Transvaginal natural orifice transluminal endoscopic surgery (vNOTES) in gynecologic surgeries: A systematic review. Asian J Surg. 2020 Jan;43(1):44-51. doi: 10.1016/j.asjsur.2019.07.014. Epub 2019 Aug 20.

  PMID: 31444108 RESULT

• Baekelandt J, De Mulder PA, Le Roy I, Mathieu C, Laenen A, Enzlin P, Weyers S, Mol BW, Bosteels JJ. Postoperative outcomes and quality of life following hysterectomy by natural orifice transluminal endoscopic surgery (NOTES) compared to laparoscopy in women with a non-prolapsed uterus and benign gynaecological disease: a systematic review and meta-analysis. Eur J Obstet Gynecol Reprod Biol. 2017 Jan;208:6-15. doi: 10.1016/j.ejogrb.2016.10.044. Epub 2016 Oct 29.

  PMID: 27880893 RESULT

• Coomber RS, Sodergren MH, Clark J, Teare J, Yang GZ, Darzi A. Natural orifice translumenal endoscopic surgery applications in clinical practice. World J Gastrointest Endosc. 2012 Mar 16;4(3):65-74. doi: 10.4253/wjge.v4.i3.65.

  PMID: 22442743 RESULT

• Ahn KH, Song JY, Kim SH, Lee KW, Kim T. Transvaginal single-port natural orifice transluminal endoscopic surgery for benign uterine adnexal pathologies. J Minim Invasive Gynecol. 2012 Sep-Oct;19(5):631-5. doi: 10.1016/j.jmig.2012.04.001. Epub 2012 Jul 3.

  PMID: 22763314 RESULT

• Kapurubandara S, Lowenstein L, Salvay H, Herijgers A, King J, Baekelandt J. Consensus on safe implementation of vaginal natural orifice transluminal endoscopic surgery (vNOTES). Eur J Obstet Gynecol Reprod Biol. 2021 Aug;263:216-222. doi: 10.1016/j.ejogrb.2021.06.019. Epub 2021 Jun 17.

  PMID: 34237485 RESULT

Study Officials

• Aya Mohr-Sasson

  The University of Texas Health Science Center, Houston, TX

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Aya Mohr-Sasson, M.D

CONTACT

13462704682; aya.mohrsasson@uth.tmc.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principle investigator

Study Record Dates

• First Submitted: November 10, 2022
• First Posted: November 21, 2022
• Study Start: May 16, 2022
• Primary Completion: December 1, 2025
• Study Completion: December 1, 2025
• Last Updated: November 14, 2024

Record last verified: 2024-11

Locations

US (1)