Laparoscopic Assisted Transvaginal Cholecystecomy
Primary Purpose
Cholelithiasis
Status
Withdrawn
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Laparoscopic Assisted Transvaginal Cholecystectomy
Sponsored by
About this trial
This is an interventional other trial for Cholelithiasis focused on measuring cholecystectomy, gall stone surgery, scarless surgery, cholelithiasis
Eligibility Criteria
Inclusion Criteria:
- Scheduled to undergo elective laparoscopic cholecystectomy
- Women 18-75 years of age
- English or Spanish speaking
Exclusion Criteria:
- 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
Sites / Locations
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Transvaginal cholecystectomy under laparoscopic guidance
Arm Description
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).
Outcomes
Primary Outcome Measures
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.
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.
Secondary Outcome Measures
Full Information
NCT ID
NCT04113590
First Posted
July 3, 2012
Last Updated
October 1, 2019
Sponsor
University of Texas Southwestern Medical Center
1. Study Identification
Unique Protocol Identification Number
NCT04113590
Brief Title
Laparoscopic Assisted Transvaginal Cholecystecomy
Official Title
Laparoscopic Assisted Transvaginal Cholecystecomy
Study Type
Interventional
2. Study Status
Record Verification Date
October 2019
Overall Recruitment Status
Withdrawn
Why Stopped
no patients were enrolled
Study Start Date
August 2011 (undefined)
Primary Completion Date
December 2012 (Anticipated)
Study Completion Date
December 2012 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Texas Southwestern Medical Center
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
Detailed Description
20 female patients will be enrolled. Patients who are scheduled to undergo elective laparoscopic cholecystectomy will be invited to participate in this study. The laparoscopic instrumentation will be sterilized using standard methods. Conventional and new laparoscopic and endoscopic equipment will be used for this project; all equipment is commercially available and is FDA-approved for laparoscopic procedures. Access will be obtained into the peritoneal cavity at the umbilicus in a standard fashion, either by use of a Veress needle technique or by insertion of a trocar using the open technique. Through a single umbilical incision, a 5mm trocar will be placed into the peritoneal cavity. A 5mm laparoscope will then be inserted into the peritoneal cavity. This will be used to monitor safe peritoneal entry of a dilating12mm transvaginal trocar. Subsequent operative visualization will be by use of a flexible endoscope which will be placed through the transvaginal port. The gallbladder will be retracted using sutures as well as endoscopic and / or laparoscopic graspers. In order to obtain the critical view of safety [5] the cystic duct and artery will be dissected, ligated and divided by use of conventional laparoscopic and new articulating instruments. The dissected gallbladder will be retrieved transvaginally. If for any reason suitable retraction or dissection cannot be performed using the transvaginal strategy, the case will be promptly converted to a standard laparoscopic approach by the insertion of additional transabdominal trocars.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cholelithiasis
Keywords
cholecystectomy, gall stone surgery, scarless surgery, cholelithiasis
7. Study Design
Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
0 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Transvaginal cholecystectomy under laparoscopic guidance
Arm Type
Experimental
Arm Description
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).
Intervention Type
Procedure
Intervention Name(s)
Laparoscopic Assisted Transvaginal Cholecystectomy
Other Intervention Name(s)
Transvaginal (TV) NOTES, scarless cholecystectomy, cholecystectomy
Intervention Description
Perform transvaginal cholecystectomy while obtaining safe access under laparoscopic visualization
Primary Outcome Measure Information:
Title
Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability] using a Quality of Life scale
Description
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.
Time Frame
23 hours post op
Title
Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability] using a Visual Analog Scale
Description
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.
Time Frame
23 hours post op
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Scheduled to undergo elective laparoscopic cholecystectomy
Women 18-75 years of age
English or Spanish speaking
Exclusion Criteria:
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Daniel Scott, MD
Organizational Affiliation
UT Southwestern
Official's Role
Principal Investigator
12. IPD Sharing Statement
Citations:
PubMed Identifier
17704871
Citation
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.
Results Reference
background
PubMed Identifier
18027043
Citation
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.
Results Reference
background
PubMed Identifier
21449152
Citation
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.
Results Reference
background
PubMed Identifier
20035352
Citation
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.
Results Reference
background
PubMed Identifier
18722948
Citation
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.
Results Reference
background
PubMed Identifier
21553172
Citation
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.
Results Reference
background
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Laparoscopic Assisted Transvaginal Cholecystecomy
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