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

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.

Study Overview

• Status: Completed
• Conditions: Endometrial Cancer; Extreme Obesity
• Intervention / Treatment: Procedure: Transvaginal natural orifice endoscopic surgery for endometrial cancer staging

• Study Type: Observational
• Enrollment (Actual): 6

Contacts and Locations

Study Locations

• Turkey
  • Kartal
    • Istanbul, Kartal, Turkey, 34890
      • University of Health Sciences Kartal Dr. Lütfi Kirdar Training and Research Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

• Sampling Method: Non-Probability Sample

Study Population

Extreme obese patients with early stage type-1 endometrial cancer

Description

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 Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
extremely obese patients with early-stage endometrial cancer	Procedure: Transvaginal natural orifice endoscopic surgery for endometrial cancer staging; Cases of extreme obese patients with early stage endometrial cancer who underwent v-NOTES

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Operating time	The operation time in minutes. The operation time was from commencement of the colpotomy incision to vaginal closure.	4 hours
Any conversion to conventional laparoscopy or laparotomy	Number of the patients whose surgery couldn't completed by transvaginal natural orifice surgery.	4 hours
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
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
Any intra- or post-operative complication	Number of the patients who have any complication during or after transvaginal natural orifice surgery.	6 months
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
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
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

Collaborators and Investigators

• Sponsor: Dr. Lutfi Kirdar Kartal Training and Research Hospital
• Investigators: Study Director: Ahmet Kale, Prof.Dr., Kartal Dr.Lutfi Kirdar Research and Training Hospital

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2019
• Primary Completion (Actual): June 30, 2019
• Study Completion (Actual): June 30, 2019

Study Registration Dates

• First Submitted: January 22, 2020
• First Submitted That Met QC Criteria: January 22, 2020
• First Posted (Actual): January 27, 2020

Study Record Updates

• Last Update Posted (Actual): February 11, 2020
• Last Update Submitted That Met QC Criteria: February 7, 2020
• Last Verified: February 1, 2020

More Information

Terms related to this study

• Keywords: transvaginal NOTES; Early stage endometrial cancer; extreme obesity
• Additional Relevant MeSH Terms: Neoplasms; Urogenital Neoplasms; Neoplasms by Site; Uterine Neoplasms; Genital Neoplasms, Female; Uterine Diseases; Endometrial Neoplasms
• Other Study ID Numbers: v-NOTESandobesity

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No