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Transvaginal Natural Orifice Endoscopic Surgery for Extremely Obese Patients With Early-stage Endometrial Cancer

Transvaginal Natural Orifice Endoscopic Surgery (v-NOTES) for Extremely Obese Patients With Early-stage Endometrial Cancer

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT04240730
Enrollment
6
Registered
2020-01-27
Start date
2019-01-01
Completion date
2019-06-30
Last updated
2020-02-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Endometrial Cancer, Extreme Obesity

Keywords

Early stage endometrial cancer, extreme obesity, transvaginal NOTES

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.

Interventions

PROCEDURETransvaginal natural orifice endoscopic surgery for endometrial cancer staging

Cases of extreme obese patients with early stage endometrial cancer who underwent v-NOTES

Sponsors

Dr. Lutfi Kirdar Kartal Training and Research Hospital
Lead SponsorOTHER_GOV

Study design

Observational model
CASE_ONLY
Time perspective
RETROSPECTIVE

Eligibility

Sex/Gender
FEMALE
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

Design outcomes

Primary

MeasureTime frameDescription
Operating time4 hoursThe operation time in minutes. The operation time was from commencement of the colpotomy incision to vaginal closure.
Any conversion to conventional laparoscopy or laparotomy4 hoursNumber of the patients whose surgery couldn't completed by transvaginal natural orifice surgery.
Pre- and post-operative hemoglobin levels24 hoursHemoglobin levels in g/dL. Hemoglobin levels of the patients before surgery and on postoperative day 1.
Length of hospital stay2 dayLength of hospital stay in days. Duration of hospital stay was calculated from the patient's admission until hospital discharge.
Any intra- or post-operative complication6 monthsNumber of the patients who have any complication during or after transvaginal natural orifice surgery.
pain scores6 hoursPain 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).

Countries

Turkey (Türkiye)

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026