Transvaginal Natural Orifice Endoscopic Surgery (v-NOTES) for Extremely Obese Patients With Early-stage Endometrial Cancer
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Enrollment
- 6
- Locations
- 1
- Primary Endpoint
- Pre- and post-operative hemoglobin levels
Study Overview
Brief Summary
The aim of this study is to investigate the feasibility and efficacy of the v-NOTES approach for extremely obese patients with early-stage type 1 endometrial cancer.
Study Design
- Study Type
- Observational
- Observational Model
- Case Only
- Time Perspective
- Retrospective
Eligibility Criteria
- Sex
- Female
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Extreme obese patients
- •Early stage type-1 endometrial cancer proved by endometrial sampling
Exclusion Criteria
- •any contraindication for pneumoperitoneum
- •any contraindication for the dorsal lithotomy position
- •any contraindication for general anesthesia,
- •any contraindication for v-NOTES
- •suspicion of pelvic adhesions
- •presence or suspicion of obliteration of the pouch of Douglas
Outcomes
Primary Outcomes
Pre- and post-operative hemoglobin levels
Time Frame: 24 hours
Hemoglobin levels in g/dL. Hemoglobin levels of the patients before surgery and on postoperative day 1.
Any conversion to conventional laparoscopy or laparotomy
Time Frame: 4 hours
Number of the patients whose surgery couldn't completed by transvaginal natural orifice surgery.
Operating time
Time Frame: 4 hours
The operation time in minutes. The operation time was from commencement of the colpotomy incision to vaginal closure.
Length of hospital stay
Time Frame: 2 day
Length of hospital stay in days. Duration of hospital stay was calculated from the patient's admission until hospital discharge.
Any intra- or post-operative complication
Time Frame: 6 months
Number of the patients who have any complication during or after transvaginal natural orifice surgery.
pain scores
Time Frame: 24 hours
Pain scores in VAS score. Pain scores were evaluated using a visual analog scale (VAS). Scores are based on self-reported measures of pain that are recorded with a single handwritten mark placed at one point along the length of a 10-cm line that represents a continuum between the two ends of the scale-"no pain" on the left end (0 cm) of the scale and the "worst pain" on the right end of the scale (10 cm).
Secondary Outcomes
No secondary outcomes reported
Investigators
Emre Mat
Head of Gynecologic Oncology
Dr. Lutfi Kirdar Kartal Training and Research Hospital