Bariatric - Sleeve Gastrectomy Staple Line Reinforcement, Gynecology - Vaginal Cuff Closure
Conditions
Keywords
STRATAFIX SPIRAL PDS PLUS, ROBOTIC SUTURING,
Brief summary
This single-arm, prospective, observational multicenter study will collect clinical data in a post-market setting across two different specialties in Robotic surgical procedures: Bariatric Sleeve gastrectomy (Staple line reinforcement) and Hysterectomy (Vaginal cuff closure). Investigators will perform the procedure using SFX Spiral PDS Plus in compliance with their standard surgical approach and the IFU.
Interventions
DEVICERobotic Suturing of gastric sleeve oversew and vaginal cuff closure
1. Robotic Bariatric Sleeve gastrectomy 2. Robotic Hysterectomy with or without oophorectomy;
Sponsors
Ethicon, Inc.
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
Inclusion: 1. Elect to have a Robotic Bariatric Sleeve Gastrectomy or Robotic Total Hysterectomy where STRATAFIX™ Spiral PDS™ Plus device is used for staple line re-enforcement or vaginal cuff closure, respectively 2. Are willing and able to give consent and comply with all study-related evaluations and treatment scheduled 3. Subjects are ≥ 18 years of age Exclusion: 1. Physical or psychological condition which would impair study participation or are unwilling or unable to participate in all required study visits 2. Any pre-operative or intra-operative findings identified by the surgeon that may preclude the use of study product 3. Enrolled in a concurrent clinical study (drug/device) that might affect current study primary or secondary endpoints 4. Allergic to poly (p-dioxanon), IRGACARE®\* MP (triclosan) or D\&C Violet No. 2 colorant 5. Pregnant or lactating female subjects as confirmed prior to the procedure 6. Subjects undergoing radical hysterectomy (Type B, C and D) according to Querleu \& Morrow classification or gastric sleeve revision surgery
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of subjects with no bleeding or mild bleeding (defined as success) at the completion of the suturing at the organ layer (vaginal cuff closure or gastric staple line reinforcement using STRATAFIX™ Spiral PDS™ Plus). | Intra-op assessment (During Surgery; after suturing of the target tissue, Day of surgery) | The bleeding grade assessment used for the primary endpoint will be made right after the suturing is completed. Any re-bleeding after the initial assessment (just before the removal of the optics and trocars) from the suture line after this assessment will be considered a failure for the primary performance endpoint. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Qualitative Assessment of Suture Handling | Intra-op (at surgery, after suturing of the target tissue layer, Day of surgery) | Suture breakage, correction suture used, reinforcement suture used, needle penetration, size, attachment; all rated 1-5 |
| Time to Closure (in minutes/seconds) | Intra-op (during suturing of the target tissue, Day of surgery) | The time to closure is defined as time in minutes and seconds between placement of the first suture throw in the target tissue to the completion of closure of that layer. The time in minutes and seconds will be captured as per operating room procedure. |
| Overall procedure time (first incision to skin closure) | Intra-op (during the surgery, Day of surgery) | Overall time is calculated as first incision to skin closure |
| Length of stay in hours | Post-Operative up to 48 hrs | Time from admission to discharge |
| Estimated intra-operative blood loss per institutional standard of care and incidence of subjects requiring blood transfusion | Intra-Op (during the surgery, Day of surgery) | Blood loss calculated as per the standard of care of each institution |
| Intra-operative leak test in bariatric procedure as per institutional standard of care, if any | Intra-op (during Surgery; Day of surgery) | Leak test for sleeve gastrectomy patient as per institution standard |
| Post-operative male/female dyspareunia related to sutures (total hysterectomy subjects) | 90 days post-operative (+/- 30 days), 180 days post-operative (+/- 30 days) | Dyspareunia here is defined as painful sexual intercourse due to the sutures |
| Incisional site physical assessment:is suture palpable, suture line intact, or tender (all rated yes/no) | 14 days post-perative 90 days post-operative (+/- 30 days), 180 days post-operative (+/- 30 days) | Incisional site will be assessed for hysterectomy subjects to see if the suture is palpable suture, tender or intact at the target site |
| Abnormal vaginal discharge (total hysterectomy subjects) | 14 days post-perative 90 days post-operative (+/- 30 days), 180 days post-operative (+/- 30 days) | Hysterectomy patients will be assessed for any abnormal vaginal discharge if any. |
| C-SATS GEARS score | Intra-op (during the surgery, Day of surgery) | Global Evaluative Assessment of Robotic Skills (GEARS). Its a validated assessment tool for grading overall technical proficiency for robotic surgery. GEARS measures manual dexterity and fluidity of motion and does not define surgical or clinical judgement. The scales are Depth perception, Bimanual dexterity, efficiency, force sensitivity and robotic control.Each scale is scored 1 - 5, which means the total score could range from 5 - 25. |
Countries
Germany, Italy, United States
Outcome results
None listed