N/A
N=53
Evaluation of 3D Visualization for Total Colectomy
Ulcerative Colitis
Bottom Line
View on ClinicalTrials.gov: NCT02370056 ↗Enrolled (actual)
53
Serious AEs
28.3%
Results posted
Dec 2020
Primary outcome: Primary: Operating Time — 75.3; 82.7 minutes
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- 3-dimensional visualization (Diagnostic_test); 2-dimensional visualization (Diagnostic_test)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- The Cleveland Clinic
- Primary completion
- May 2019
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Operating Time |
75.3; 82.7 | — |
| SECONDARY Major Complication |
8; 8 | — |
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
Eligibility Criteria
Inclusion Criteria
- 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
Exclusion Criteria
- Any preoperative diagnosis other than UC
- Patient age 80
- Emergency surgery
- Previous gastrointestinal surgery
- BMI>30
- Pregnancy
- Presence of any gastrointestinal tract malignancy
- Segmental colon resections, completion proctectomy, total proctocolectomy, pouch procedures
Data sourced from ClinicalTrials.gov (NCT02370056). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.