Transvaginal Natural Orifice Endoscopic Surgery (v-NOTES) for Extremely Obese Patients With Early-stage Endometrial Cancer
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Endometrial Cancer
- Sponsor
- Dr. Lutfi Kirdar Kartal Training and Research Hospital
- Enrollment
- 6
- Locations
- 1
- Primary Endpoint
- Pre- and post-operative hemoglobin levels
- Status
- Completed
- Last Updated
- 6 years ago
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.
Investigators
Emre Mat
Head of Gynecologic Oncology
Dr. Lutfi Kirdar Kartal Training and Research Hospital
Eligibility Criteria
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).