Trial Outcomes & Findings for Evaluation of 3D Visualization for Total Colectomy (NCT NCT02370056)

NCT ID: NCT02370056

Last Updated: 2021-05-12

Results Overview

total operating time

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 53 participants
• Primary outcome timeframe: 180 minutes
• Results posted on: 2021-05-12

Participant Flow

Participant milestones

Measure	3D Visualization 3-dimensional visualization: In this group, total laparoscopic abdominal colectomy will be performed for patients diagnosed with ulcerative colitis by using 3D Laparoscopic Surgical Video System. This group will be consisted of 27 patients, 9 colectomies performed by 3 surgeons.Effect of using 3D Laparoscopic Surgical Video System on operative outcomes will be evaluated. 3-dimensional visualization: Subjects are receiving Standard of Care Colectomy for Ulcerative Colitis visualized in 3D mode	2D Visualization 2-dimensional visualization: In this group, total laparoscopic abdominal colectomy will be performed for patients diagnosed with ulcerative colitis by using conventional Laparoscopic Surgical Video System. This group will be consisted of 27 patients, 9 colectomies performed by 3 surgeons and outcomes will be evaluated. 2-dimensional visualization: Subjects are receiving Standard of Care Colectomy for Ulcerative Colitis visualized in 2D mode
Overall Study STARTED	27	26
Overall Study COMPLETED	27	26
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

53 subjects total were included in analysis

Baseline characteristics by cohort

Measure	3D Visualization n=27 Participants 3-dimensional visualization: In this group, total laparoscopic abdominal colectomy will be performed for patients diagnosed with ulcerative colitis by using 3D Laparoscopic Surgical Video System. This group will be consisted of 27 patients, 9 colectomies performed by 3 surgeons.Effect of using 3D Laparoscopic Surgical Video System on operative outcomes will be evaluated. 3-dimensional visualization: Subjects are receiving Standard of Care Colectomy for Ulcerative Colitis visualized in 3D mode	2D Visualization n=26 Participants 2-dimensional visualization: In this group, total laparoscopic abdominal colectomy will be performed for patients diagnosed with ulcerative colitis by using conventional Laparoscopic Surgical Video System. This group will be consisted of 27 patients, 9 colectomies performed by 3 surgeons and outcomes will be evaluated. 2-dimensional visualization: Subjects are receiving Standard of Care Colectomy for Ulcerative Colitis visualized in 2D mode	Total n=53 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=27 Participants	0 Participants n=26 Participants	0 Participants n=53 Participants
Age, Categorical Between 18 and 65 years	25 Participants n=27 Participants	21 Participants n=26 Participants	46 Participants n=53 Participants
Age, Categorical >=65 years	2 Participants n=27 Participants	5 Participants n=26 Participants	7 Participants n=53 Participants
Age, Continuous	36.8 years STANDARD_DEVIATION 15.2 • n=27 Participants • 53 subjects total were included in analysis	43.2 years STANDARD_DEVIATION 17.0 • n=26 Participants • 53 subjects total were included in analysis	40.0 years STANDARD_DEVIATION 16.3 • n=53 Participants • 53 subjects total were included in analysis
Sex: Female, Male Female	11 Participants n=27 Participants	12 Participants n=26 Participants	23 Participants n=53 Participants
Sex: Female, Male Male	16 Participants n=27 Participants	14 Participants n=26 Participants	30 Participants n=53 Participants
Race and Ethnicity Not Collected	—	—	0 Participants Race and Ethnicity were not collected from any participant.
Region of Enrollment United States	27 participants n=27 Participants	26 participants n=26 Participants	53 participants n=53 Participants
Average BMI	23.0 kg/m^2 STANDARD_DEVIATION 4.25 • n=27 Participants	23.9 kg/m^2 STANDARD_DEVIATION 5.17 • n=26 Participants	23.5 kg/m^2 STANDARD_DEVIATION 4.72 • n=53 Participants

PRIMARY outcome

Timeframe: 180 minutes

total operating time

Outcome measures

Measure	3D Visualization n=27 Participants 3-dimensional visualization: In this group, total laparoscopic abdominal colectomy will be performed for patients diagnosed with ulcerative colitis by using 3D Laparoscopic Surgical Video System. This group will be consisted of 27 patients, 9 colectomies performed by 3 surgeons.Effect of using 3D Laparoscopic Surgical Video System on operative outcomes will be evaluated. 3-dimensional visualization: Subjects are receiving Standard of Care Colectomy for Ulcerative Colitis visualized in 3D mode	2D Visualization n=26 Participants 2-dimensional visualization: In this group, total laparoscopic abdominal colectomy will be performed for patients diagnosed with ulcerative colitis by using conventional Laparoscopic Surgical Video System. This group will be consisted of 27 patients, 9 colectomies performed by 3 surgeons and outcomes will be evaluated. 2-dimensional visualization: Subjects are receiving Standard of Care Colectomy for Ulcerative Colitis visualized in 2D mode
Operating Time	75.3 minutes Standard Deviation 30.8	82.7 minutes Standard Deviation 38.6

SECONDARY outcome

Timeframe: 180 minutes

Number of Participants with Intraoperative Complications

Outcome measures

Measure	3D Visualization n=27 Participants 3-dimensional visualization: In this group, total laparoscopic abdominal colectomy will be performed for patients diagnosed with ulcerative colitis by using 3D Laparoscopic Surgical Video System. This group will be consisted of 27 patients, 9 colectomies performed by 3 surgeons.Effect of using 3D Laparoscopic Surgical Video System on operative outcomes will be evaluated. 3-dimensional visualization: Subjects are receiving Standard of Care Colectomy for Ulcerative Colitis visualized in 3D mode	2D Visualization n=26 Participants 2-dimensional visualization: In this group, total laparoscopic abdominal colectomy will be performed for patients diagnosed with ulcerative colitis by using conventional Laparoscopic Surgical Video System. This group will be consisted of 27 patients, 9 colectomies performed by 3 surgeons and outcomes will be evaluated. 2-dimensional visualization: Subjects are receiving Standard of Care Colectomy for Ulcerative Colitis visualized in 2D mode
Major Complication	8 Participants	8 Participants

Adverse Events

3D Visualization

Serious events: 8 serious events

Other events: 0 other events

Deaths: 0 deaths

2D Visualization

Serious events: 7 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Measure	3D Visualization n=27 participants at risk 3-dimensional visualization: In this group, total laparoscopic abdominal colectomy will be performed for patients diagnosed with ulcerative colitis by using 3D Laparoscopic Surgical Video System. This group will be consisted of 27 patients, 9 colectomies performed by 3 surgeons.Effect of using 3D Laparoscopic Surgical Video System on operative outcomes will be evaluated. 3-dimensional visualization: Subjects are receiving Standard of Care Colectomy for Ulcerative Colitis visualized in 3D mode	2D Visualization n=26 participants at risk 2-dimensional visualization: In this group, total laparoscopic abdominal colectomy will be performed for patients diagnosed with ulcerative colitis by using conventional Laparoscopic Surgical Video System. This group will be consisted of 27 patients, 9 colectomies performed by 3 surgeons and outcomes will be evaluated. 2-dimensional visualization: Subjects are receiving Standard of Care Colectomy for Ulcerative Colitis visualized in 2D mode
Surgical and medical procedures Post-operative ileus	14.8% 4/27 • Number of events 4 • The standard post-operative period of 30 days.	3.8% 1/26 • Number of events 1 • The standard post-operative period of 30 days.
Surgical and medical procedures Wound Dehiscence	3.7% 1/27 • Number of events 1 • The standard post-operative period of 30 days.	0.00% 0/26 • The standard post-operative period of 30 days.
Surgical and medical procedures Portal vein thrombosis/Deep vein thrombosis	0.00% 0/27 • The standard post-operative period of 30 days.	7.7% 2/26 • Number of events 2 • The standard post-operative period of 30 days.
Surgical and medical procedures Surgical Site Infection	0.00% 0/27 • The standard post-operative period of 30 days.	7.7% 2/26 • Number of events 2 • The standard post-operative period of 30 days.
Surgical and medical procedures Readmission	11.1% 3/27 • Number of events 3 • The standard post-operative period of 30 days.	7.7% 2/26 • Number of events 2 • The standard post-operative period of 30 days.

Other adverse events

Adverse event data not reported

Additional Information

Dr. Emre Gorgun

Cleveland Clinic

Phone: 216 444-1244

Email: GORGUNE@ccf.org

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place