Evaluation of 3D Visualization for Total Colectomy

NCT02370056 | Completed Results

• 1 other identifier: CCFJJN4
• Study Type: interventional
• Target: 53
• Locations: 1 country
• Sites: 1

Brief Summary

The anticipated advantages of 3D laparoscopic visualization for the surgeon are greater accuracy and speed in manual skills, translating to decreased operative time, reduced learning curve, and superior safety.We aimed to determine the feasibility of the laparoscopic approach using 3D visualization in the surgical treatment of ulcerative colitis

Conditions

Ulcerative Colitis

Outcome Measures

Primary Outcomes (1)

• Operating Time

  total operating time

  180 minutes

Secondary Outcomes (1)

• Major Complication

  180 minutes

Study Arms (2)

3D Visualization

EXPERIMENTAL

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.

Diagnostic Test: 3-dimensional visualization

2D Visualization

ACTIVE COMPARATOR

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.

Diagnostic Test: 2-dimensional visualization

Interventions

3-dimensional visualization DIAGNOSTIC_TEST

Subjects are receiving Standard of Care Colectomy for Ulcerative Colitis visualized in 3D mode

3D Visualization

2-dimensional visualization DIAGNOSTIC_TEST

Subjects are receiving Standard of Care Colectomy for Ulcerative Colitis visualized in 2D mode

2D Visualization

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Indication for surgery must be Ulcerative Colitis
• Patient age between 18 and 80
• Elective procedure
• BMI between 17 and 30
• Total colectomy with end ileostomy, without proctectomy

You may not qualify if:

• Any preoperative diagnosis other than UC
• Patient age\< 18, or \>80
• Emergency surgery
• Previous gastrointestinal surgery
• BMI\>30
• Pregnancy
• Presence of any gastrointestinal tract malignancy
• Segmental colon resections, completion proctectomy, total proctocolectomy, pouch procedures

Sponsors & Collaborators

• The Cleveland Clinic: lead

Study Sites (1)

Cleveland Clinic

Cleveland, Ohio, 44195, United States

Location

MeSH Terms

Conditions

Colitis, Ulcerative

Condition Hierarchy (Ancestors)

Colitis; Gastroenteritis; Gastrointestinal Diseases; Digestive System Diseases; Inflammatory Bowel Diseases; Colonic Diseases; Intestinal Diseases

Results Point of Contact

• Title: Dr. Emre Gorgun
• Organization: Cleveland Clinic

GORGUNE@ccf.org

216 444-1244

Study Officials

• Emre Gorgun, MD

  The Cleveland Clinic

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD

Study Record Dates

• First Submitted: February 9, 2015
• First Posted: February 24, 2015
• Study Start: March 1, 2015
• Primary Completion: May 17, 2019
• Study Completion: May 17, 2019
• Last Updated: May 12, 2021
• Results First Posted: December 17, 2020

Record last verified: 2021-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)