Hysterectomy
Conditions
Brief summary
This study has been designed as a prospective randomized trial to be performed at Bridgeport Hospital. Patients planning to undergo a laparoscopic or robotically assisted total laparoscopic hysterectomy with or without removal of adnexal structures will be recruited by the Bridgeport Hospital Minimally Invasive Gynecologic Surgery fellows during their preoperative office visit at the Bridgeport Hospital Gynecologic Oncology office. If enrolled, they will be assigned a sequential study identification number. During their preoperative exam, a baseline POP-Q will be performed. Demographic information will be recorded from the electronic medical record.
Interventions
PROCEDUREVaginal cuff closure - vertical
Vaginal cuff is closed vertically.
PROCEDUREVaginal cuff closure - horizontal
Vaginal cuff is closed horizontally.
Sponsors
Bridgeport Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Undergoing laparoscopic or robotic-assisted laparoscopic hysterectomy * Under the care of Dr. Dan-Arin Silasi or Dr. Masoud Azodi at Bridgeport Hospital * Planning to follow up at the Gynecologic Oncology office at Bridgeport Hospital * Age 18 or older * Able to give informed consent to participate in the research study
Exclusion criteria
* Age less than 18 * Unable to give informed consent * Patients undergoing radical hysterectomy * Patients receiving vaginal cuff radiation within the study period * Patients undergoing concomitant pelvic floor or vaginal suspension procedure
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Vaginal length | 1-3 weeks postop | Vaginal length will be measured in cm by standard POP-Q measurements |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Vaginal length | 3-4 months postop | Vaginal length will be measured in cm by standard POP-Q measurements |
| Cuff closure time | intra-op | Time will be recorded by the circulating nurse in seconds |
Other
| Measure | Time frame | Description |
|---|---|---|
| Complications | Up to 4 months post-op | Including urinary retention, bladder injury, ureteral injury, cuff dehiscence, cuff bleeding requiring further procedures or cauterization |
Countries
United States
Outcome results
None listed