NCT04113590

Brief Summary

Laparoscopic cholecystectomy is currently the standard procedure for removing the gallbladder. This procedure usually requires the insertion of four trocars into the abdomen for passage of laparoscopic instruments; each trocar requires a small incision, which results in postoperative pain and scarring. There has recently been a tremendous surge in interest within the surgical community to further reduce the pain, invasiveness, and cosmesis of laparoscopic surgery. To achieve this goal, surgeons are either reducing the number of trocars placed through the abdominal wall or eliminating them completely The goal of this project is to evaluate the feasibility of performing transvaginal cholecystectomy while obtaining safe access under laparoscopic visualization. This has the potential to decrease postoperative pain, improve cosmesis, and lead to a shorter recovery following cholecystectomy.

Trial Health

15
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Timeline
Completed

Started Aug 2011

Status
withdrawn

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2011

Completed
11 months until next milestone

First Submitted

Initial submission to the registry

July 3, 2012

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2012

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2012

Completed
6.8 years until next milestone

First Posted

Study publicly available on registry

October 3, 2019

Completed
Last Updated

October 3, 2019

Status Verified

October 1, 2019

Enrollment Period

1.3 years

First QC Date

July 3, 2012

Last Update Submit

October 1, 2019

Conditions

Cholelithiasis

Keywords

cholecystectomygall stone surgeryscarless surgerycholelithiasis

Outcome Measures

Primary Outcomes (2)

  • Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability] using a Quality of Life scale

    The primary outcome of this study will be to evaluate the feasibility of performing a transvaginal cholecystectomy while obtaining safe access under laparoscopic visualization. A postoperative Quality of Life questionnaire will be given to the patient to access pain. We will also address whether cosmesis was a factor for their decision. Operative time will be tracked as well as standard operative outcomes including any complications. Patients will be kept for 23 hours observation postoperatively and will follow up in the clinic.

    23 hours post op

  • Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability] using a Visual Analog Scale

    The primary outcome of this study will be to evaluate the feasibility of performing a transvaginal cholecystectomy while obtaining safe access under laparoscopic visualization. A Visual Analog Scale for pain will be given to the patient to access pain. We will also address whether cosmesis was a factor for their decision. Operative time will be tracked as well as standard operative outcomes including any complications. Patients will be kept for 23 hours observation postoperatively and will follow up in the clinic.The Visual Analog Scale is a scale from 0-10, with 10 being a better outcome.

    23 hours post op

Study Arms (1)

Transvaginal cholecystectomy under laparoscopic guidance

EXPERIMENTAL

The removal of the gallbladder through several small incisions using a camera to see is called laparoscopic cholecystectomy. This study is being done to evaluate whether cholecystectomy can be performed through a natural orifice (the vagina) with minimal laparoscopic assistance (only one abdominal trocar versus four in the routine laparoscopic cholecystectomy).

Procedure: Laparoscopic Assisted Transvaginal Cholecystectomy

Interventions

Laparoscopic Assisted Transvaginal CholecystectomyPROCEDURE

Perform transvaginal cholecystectomy while obtaining safe access under laparoscopic visualization

Also known as: Transvaginal (TV) NOTES, scarless cholecystectomy, cholecystectomy
Transvaginal cholecystectomy under laparoscopic guidance

Eligibility Criteria

Age18 Years - 75 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Scheduled to undergo elective laparoscopic cholecystectomy
  • Women 18-75 years of age
  • English or Spanish speaking

You may not qualify if:

  • American Society of Anesthesiologists (ASA) classification of ≥ 3
  • Morbid obesity (BMI ≥35)
  • Pregnant women
  • Acute cholecystitis
  • Any ongoing intra-abdominal infection
  • Prior upper abdominal or pelvic surgery and/or adhesions
  • Virgins
  • Women with an active sexually transmitted disease or any vaginal infection
  • History of dyspareunia

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (6)

  • Scott DJ, Tang SJ, Fernandez R, Bergs R, Goova MT, Zeltser I, Kehdy FJ, Cadeddu JA. Completely transvaginal NOTES cholecystectomy using magnetically anchored instruments. Surg Endosc. 2007 Dec;21(12):2308-16. doi: 10.1007/s00464-007-9498-z. Epub 2007 Aug 18.

    PMID: 17704871BACKGROUND

  • Zorron R, Maggioni LC, Pombo L, Oliveira AL, Carvalho GL, Filgueiras M. NOTES transvaginal cholecystectomy: preliminary clinical application. Surg Endosc. 2008 Feb;22(2):542-7. doi: 10.1007/s00464-007-9646-5. Epub 2007 Nov 20.

    PMID: 18027043BACKGROUND

  • Elazary R, Khalaileh A, Shussman N, Schlager A, Horgan S, Talamini MA, Rivkind AI, Mintz Y. [Surgery without incisions--the third generation of surgery]. Harefuah. 2011 Jan;150(1):25-8, 69. Hebrew.

    PMID: 21449152BACKGROUND

  • Schlager A, Khalaileh A, Shussman N, Elazary R, Keidar A, Pikarsky AJ, Ben-Shushan A, Shibolet O, Horgan S, Talamini M, Zamir G, Rivkind AI, Mintz Y. Providing more through less: current methods of retraction in SIMIS and NOTES cholecystectomy. Surg Endosc. 2010 Jul;24(7):1542-6. doi: 10.1007/s00464-009-0807-6. Epub 2009 Dec 25.

    PMID: 20035352BACKGROUND

  • Christian J, Barrier BF, Schust D, Miedema BW, Thaler K. Culdoscopy: a foundation for natural orifice surgery--past, present, and future. J Am Coll Surg. 2008 Sep;207(3):417-22. doi: 10.1016/j.jamcollsurg.2008.01.032. Epub 2008 May 5. No abstract available.

    PMID: 18722948BACKGROUND

  • Auyang ED, Santos BF, Enter DH, Hungness ES, Soper NJ. Natural orifice translumenal endoscopic surgery (NOTES((R))): a technical review. Surg Endosc. 2011 Oct;25(10):3135-48. doi: 10.1007/s00464-011-1718-x. Epub 2011 May 7.

    PMID: 21553172BACKGROUND

MeSH Terms

Conditions

Cholelithiasis

Interventions

Cholecystectomy

Condition Hierarchy (Ancestors)

Biliary Tract DiseasesDigestive System Diseases

Intervention Hierarchy (Ancestors)

Biliary Tract Surgical ProceduresDigestive System Surgical ProceduresSurgical Procedures, Operative

Study Officials

  • Daniel Scott, MD

    UT Southwestern

    PRINCIPAL INVESTIGATOR
0

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
OTHER
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 3, 2012

First Posted

October 3, 2019

Study Start

August 1, 2011

Primary Completion

December 1, 2012

Study Completion

December 1, 2012

Last Updated

October 3, 2019

Record last verified: 2019-10