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

Completed

• Conditions: Endometrial Cancer; Extreme Obesity
• Interventions: Procedure: Transvaginal natural orifice endoscopic surgery for endometrial cancer staging

• Registration Number: NCT04240730
• Lead Sponsor: Dr. Lutfi Kirdar Kartal Training and Research Hospital

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2019-01-01
• Primary Completion: 2019-06-30
• Study Completion: 2019-06-30
• Study First Submitted: 2020-01-22
• Study First Submitted QC: 2020-01-22
• Study First Posted: 2020-01-27
• Status Verified: 2020-02
• Last Update Submitted: 2020-02-07
• Last Update Posted: 2020-02-11

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 6

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

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
extremely obese patients with early-stage endometrial cancer	Transvaginal natural orifice endoscopic surgery for endometrial cancer staging	-

Primary Outcome Measures

Name	Time	Method
Pre- and post-operative hemoglobin levels	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	4 hours	Number of the patients whose surgery couldn't completed by transvaginal natural orifice surgery.
Operating time	4 hours	The operation time in minutes. The operation time was from commencement of the colpotomy incision to vaginal closure.
Length of hospital stay	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	6 months	Number of the patients who have any complication during or after transvaginal natural orifice surgery.
pain scores	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).

Trial Locations

Locations (1)

University of Health Sciences Kartal Dr. Lütfi Kirdar Training and Research Hospital; 🇹🇷 Istanbul, Kartal, Turkey