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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04240730
Other study ID # v-NOTESandobesity
Secondary ID
Status Completed
Phase
First received
Last updated
Start date January 1, 2019
Est. completion date June 30, 2019

Study information

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

Clinical Trial 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.


Recruitment information / eligibility

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

Study Design


Related Conditions & MeSH terms


Intervention

Procedure:
Transvaginal natural orifice endoscopic surgery for endometrial cancer staging
Cases of extreme obese patients with early stage endometrial cancer who underwent v-NOTES

Locations

Country Name City State
Turkey University of Health Sciences Kartal Dr. Lütfi Kirdar Training and Research Hospital Istanbul Kartal

Sponsors (1)

Lead Sponsor Collaborator
Dr. Lutfi Kirdar Kartal Training and Research Hospital

Country where clinical trial is conducted

Turkey, 

Outcome

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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