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

Endometrial Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04240730
• Other study ID #: v-NOTESandobesity
• Status: Completed
• 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
• 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

Related Conditions & MeSH terms

• Endometrial Cancer
• Endometrial Neoplasms
• Extreme Obesity

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