Endometrial Cancer Clinical Trial
Official title:
Transvaginal Natural Orifice Endoscopic Surgery (v-NOTES) for Extremely Obese Patients With Early-stage Endometrial Cancer
Verified date | February 2020 |
Source | Dr. Lutfi Kirdar Kartal Training and Research Hospital |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
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.
Status | Completed |
Enrollment | 6 |
Est. completion date | June 30, 2019 |
Est. primary completion date | June 30, 2019 |
Accepts healthy volunteers | No |
Gender | Female |
Age group | N/A and older |
Eligibility |
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 |
Country | Name | City | State |
---|---|---|---|
Turkey | University of Health Sciences Kartal Dr. Lütfi Kirdar Training and Research Hospital | Istanbul | Kartal |
Lead Sponsor | Collaborator |
---|---|
Dr. Lutfi Kirdar Kartal Training and Research Hospital |
Turkey,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Operating time | The operation time in minutes. The operation time was from commencement of the colpotomy incision to vaginal closure. | 4 hours | |
Primary | Any conversion to conventional laparoscopy or laparotomy | Number of the patients whose surgery couldn't completed by transvaginal natural orifice surgery. | 4 hours | |
Primary | Pre- and post-operative hemoglobin levels | Hemoglobin levels in g/dL. Hemoglobin levels of the patients before surgery and on postoperative day 1. | 24 hours | |
Primary | Length of hospital stay | Length of hospital stay in days. Duration of hospital stay was calculated from the patient's admission until hospital discharge. | 2 day | |
Primary | Any intra- or post-operative complication | Number of the patients who have any complication during or after transvaginal natural orifice surgery. | 6 months | |
Primary | pain scores | 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). | 6 hours | |
Primary | pain scores | 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). | 12 hours | |
Primary | pain scores | 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). | 24 hours |
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