3DRCT: Does 3D Laparoscopy Improve Vaginal Cuff Suture Time?

• Sponsor: Brigham and Women's Hospital (Other)
• Overall Status: Completed
• CT.gov ID: NCT02192606
• Collaborator: (none)
• Enrollment: 57
• Locations: 2
• Arms: 2
• Duration (Months): 34
• Patients Per Site: 28.5
• Patients Per Site Per Month: 0.8

Study Details

Study Description

Brief Summary

The objective aim is to evaluate whether the use of 3D laparoscopy facilitates the vaginal cuff closure of the vaginal cuff during a total laparoscopic hysterectomy among novice laparoscopists (PGY 2-4, Fellow). This is a randomized single blinded controlled trial comparing the difference in 2D vs. 3D in regards to vaginal cuff closure time stratified by residents and fellows. Patients will undergo a total laparoscopic hysterectomy and will be randomized to either 2D versus 3D.

Condition or Disease	Intervention/Treatment	Phase
Uterine Fibroids; Abnormal Uterine Bleeding; Pelvic Pain; Adenomyosis	Device: Storz 3D Laparoscopy System; Device: 2D Laparoscopy	N/A

Detailed Description

This is a randomized single blinded controlled trial investigating 3D laparoscopy in the clinical setting. Based on previous studies indicating 3D laparoscopy has improved skills of novice surgeons in the simulation lab, there has been no reports to date investigating the role of 3D laparoscopy in the operating room. Our study will evaluate the facility of 3D laparoscopy in the novice surgeon, mainly residents and fellow. Patients who present for a scheduled total laparoscopic hysterectomy will be randomized to either the standard 2D laparoscopy system or 3D laparoscopy system. Stratifying residents versus fellow, we will compare the time to close the vaginal cuff comparing both systems.

Study Design

• Study Type: Interventional
• Actual Enrollment: 57 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Single (Participant)
• Primary Purpose: Other
• Official Title: Does 3D Laparoscopy Improve Vaginal Cuff Suture Time? A Randomized Controlled Trial Comparing 3D Laparoscopy Versus Standard Laparoscopy
• Study Start Date: Nov 1, 2013
• Actual Primary Completion Date: Aug 1, 2016
• Actual Study Completion Date: Sep 1, 2016

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: 2D Laparoscopy The standard 2D Laparoscopy System to be used at time of the total laparoscopic hysterectomy	Device: 2D Laparoscopy; The standard 2D Laparoscopy System to be used at time of the total laparoscopic hysterectomy.
Active Comparator: 3D laparoscopy The Storz 3D Laparoscopy System is the intervention we are studying at the time of the total laparoscopic hysterectomy.	Device: Storz 3D Laparoscopy System; The Storz 3D Laparoscopy System is a new device that allows for laparoscopic surgeons to utilize 3D imaging during surgery with a fraction of the cost of the da Vinci Surgical System, a three-dimensional visual system.

Outcome Measures

Primary Outcome Measures

1. Vaginal Cuff Closure Times [Start of vaginal cuff closure to end of vaginal cuff closure]

   The primary endpoint is the vaginal cuff closure time at the time of a total laparoscopic hysterectomy. As the 2D laparoscopy system is standard during laparoscopic cases, our objective is to assess if there is a difference in vaginal cuff closure time when a 3D laparoscopy system is used instead. At time of the surgery, that patient will be randomized to either system. A resident or fellow will close the vaginal cuff and time to close the vaginal cuff will be recorded.

Secondary Outcome Measures

1. Estimated Blood Loss at the Time of Total Laparoscopic Hysterectomy [Time of Procedure End]

   The secondary endpoint is the surgeon estimated blood loss at the time of a total laparoscopic hysterectomy.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 80 Years
• Sexes Eligible for Study: Female
• Accepts Healthy Volunteers: Yes

Inclusion Criteria:

• Women with benign conditions such as uterine fibroids, menorrhagia, adenomyosis, pelvic pain, abnormal uterine bleeding

Exclusion Criteria:

• None

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Brigham & Women's Hospital	Boston	Massachusetts	United States	02115
2	Odense University Hospital	Odense		Denmark

Sponsors and Collaborators

• Brigham and Women's Hospital

Investigators

• Principal Investigator: Jon Einarsson, MD, PhD, MPH, Brigham and Women's Hospital
• Study Director: Sarah L Cohen, MD, MPH, Brigham and Women's Hospital

Study Documents (Full-Text)

None provided.

More Information

Publications

• Bhayani SB, Andriole GL. Three-Dimensional (3D) Vision: Does It Improve Laparoscopic Skills? An Assessment of a 3D Head-Mounted Visualization System. Rev Urol. 2005 Fall;7(4):211-4.
• Einarsson JI, Wang KC, Cohen SL, Sandberg EM, Vree FEM, Jonsdottir GM, Gobern J, Brown DN. A Randomized Controlled Trial of Barbed versus Traditional Suture for Vaginal Cuff Closure at Time of Total Laparoscopic Hysterectomy: Preliminary Results. Abstracts/ Journal of Minimally Invasive Gynecology. 19 (2012); S36-70.
• Tanagho YS, Andriole GL, Paradis AG, Madison KM, Sandhu GS, Varela JE, Benway BM. 2D versus 3D visualization: impact on laparoscopic proficiency using the fundamentals of laparoscopic surgery skill set. J Laparoendosc Adv Surg Tech A. 2012 Nov;22(9):865-70. doi: 10.1089/lap.2012.0220. Epub 2012 Oct 16.

• Responsible Party: Jon I. Einarsson, Division Chair, Minimally Invasive Gynecology, Brigham and Women's Hospital
• ClinicalTrials.gov Identifier: NCT02192606
• Other Study ID Numbers: 3DRCT
• First Posted: Jul 17, 2014
• Last Update Posted: Jan 24, 2018
• Last Verified: Jan 1, 2018

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Keywords provided by Jon I. Einarsson, Division Chair, Minimally Invasive Gynecology, Brigham and Women's Hospital: Laparoscopy; 3D Visual System; Total Hysterectomy
• Additional relevant MeSH terms: Leiomyoma; Uterine Hemorrhage; Adenomyosis; Pelvic Pain

Study Results

Participant Flow

Arm/Group Title	2D Laparoscopy	3D Laparoscopy
Arm/Group Description	The standard 2D Laparoscopy System to be used at time of the total laparoscopic hysterectomy 2D Laparoscopy: The standard 2D Laparoscopy System to be used at time of the total laparoscopic hysterectomy.	The Storz 3D Laparoscopy System is the intervention we are studying at the time of the total laparoscopic hysterectomy. Storz 3D Laparoscopy System: The Storz 3D Laparoscopy System is a new device that allows for laparoscopic surgeons to utilize 3D imaging during surgery with a fraction of the cost of the da Vinci Surgical System, a three-dimensional visual system.
Period Title: Overall Study
STARTED	29	28
COMPLETED	27	24
NOT COMPLETED	2	4

Baseline Characteristics

Arm/Group Title	2D Laparoscopy	3D Laparoscopy	Total
Arm/Group Description	The standard 2D Laparoscopy System to be used at time of the total laparoscopic hysterectomy 2D Laparoscopy: The standard 2D Laparoscopy System to be used at time of the total laparoscopic hysterectomy.	The Storz 3D Laparoscopy System is the intervention we are studying at the time of the total laparoscopic hysterectomy. Storz 3D Laparoscopy System: The Storz 3D Laparoscopy System is a new device that allows for laparoscopic surgeons to utilize 3D imaging during surgery with a fraction of the cost of the da Vinci Surgical System, a three-dimensional visual system.	Total of all reporting groups
Overall Participants	29	28	57
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	27.5 (5.2)	43.9 (8.2)	42.7 (7.6)
Sex: Female, Male (Count of Participants)
Female	29 100%	28 100%	57 100%
Male	0 0%	0 0%	0 0%
Race (NIH/OMB) (Count of Participants)
American Indian or Alaska Native	0 0%	0 0%	0 0%
Asian	1 3.4%	0 0%	1 1.8%
Native Hawaiian or Other Pacific Islander	0 0%	0 0%	0 0%
Black or African American	0 0%	0 0%	0 0%
White	26 89.7%	25 89.3%	51 89.5%
More than one race	0 0%	0 0%	0 0%
Unknown or Not Reported	2 6.9%	3 10.7%	5 8.8%
Region of Enrollment (participants) [Number]
United States	18 62.1%	18 64.3%	36 63.2%
Denmark	11 37.9%	10 35.7%	21 36.8%

Outcome Measures

1. Primary Outcome

Title	Vaginal Cuff Closure Times
Description	The primary endpoint is the vaginal cuff closure time at the time of a total laparoscopic hysterectomy. As the 2D laparoscopy system is standard during laparoscopic cases, our objective is to assess if there is a difference in vaginal cuff closure time when a 3D laparoscopy system is used instead. At time of the surgery, that patient will be randomized to either system. A resident or fellow will close the vaginal cuff and time to close the vaginal cuff will be recorded.
Time Frame	Start of vaginal cuff closure to end of vaginal cuff closure

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	2D Laparoscopy	3D Laparoscopy
Arm/Group Description	The standard 2D Laparoscopy System to be used at time of the total laparoscopic hysterectomy 2D Laparoscopy: The standard 2D Laparoscopy System to be used at time of the total laparoscopic hysterectomy.	The Storz 3D Laparoscopy System is the intervention we are studying at the time of the total laparoscopic hysterectomy. Storz 3D Laparoscopy System: The Storz 3D Laparoscopy System is a new device that allows for laparoscopic surgeons to utilize 3D imaging during surgery with a fraction of the cost of the da Vinci Surgical System, a three-dimensional visual system.
Measure Participants	29	28
Mean (Standard Deviation) [minutes]	10.17 (5.98)	12.54 (6.99)

2. Secondary Outcome

Title	Estimated Blood Loss at the Time of Total Laparoscopic Hysterectomy
Description	The secondary endpoint is the surgeon estimated blood loss at the time of a total laparoscopic hysterectomy.
Time Frame	Time of Procedure End

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	2D Laparoscopy	3D Laparoscopy
Arm/Group Description	The standard 2D Laparoscopy System to be used at time of the total laparoscopic hysterectomy 2D Laparoscopy: The standard 2D Laparoscopy System to be used at time of the total laparoscopic hysterectomy.	The Storz 3D Laparoscopy System is the intervention we are studying at the time of the total laparoscopic hysterectomy. Storz 3D Laparoscopy System: The Storz 3D Laparoscopy System is a new device that allows for laparoscopic surgeons to utilize 3D imaging during surgery with a fraction of the cost of the da Vinci Surgical System, a three-dimensional visual system.
Measure Participants	29	28
Mean (Standard Deviation) [millileters]	55.74 (39.36)	60.83 (62.32)

Adverse Events

Time Frame	Adverse event data was collected from the day of surgery to 8 weeks following the operation.
Arm/Group Title	2D Laparoscopy		3D Laparoscopy
Arm/Group Description	The standard 2D Laparoscopy System to be used at time of the total laparoscopic hysterectomy 2D Laparoscopy: The standard 2D Laparoscopy System to be used at time of the total laparoscopic hysterectomy.		The Storz 3D Laparoscopy System is the intervention we are studying at the time of the total laparoscopic hysterectomy. Storz 3D Laparoscopy System: The Storz 3D Laparoscopy System is a new device that allows for laparoscopic surgeons to utilize 3D imaging during surgery with a fraction of the cost of the da Vinci Surgical System, a three-dimensional visual system.
All Cause Mortality
	2D Laparoscopy		3D Laparoscopy
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/29 (0%)		0/28 (0%)
Serious Adverse Events
	2D Laparoscopy		3D Laparoscopy
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/29 (0%)		0/28 (0%)
Other (Not Including Serious) Adverse Events
	2D Laparoscopy		3D Laparoscopy
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	3/29 (10.3%)		4/28 (14.3%)
General disorders
Urinary retention	1/29 (3.4%)	1	0/28 (0%)	0
Infections and infestations
Incision cellulitis	0/29 (0%)	0	1/28 (3.6%)	1
Yeast infection	1/29 (3.4%)	1	0/28 (0%)	0
Injury, poisoning and procedural complications
Intraoperative complication	1/29 (3.4%)	1	0/28 (0%)	0
Skin and subcutaneous tissue disorders
ER visit	0/29 (0%)	0	1/28 (3.6%)	1
Iritation around abdominal surgical incision site	0/29 (0%)	0	1/28 (3.6%)	1
Surgical and medical procedures
Reoperation for vaginal cuff dehiscence	0/29 (0%)	0	1/28 (3.6%)	1

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.