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

Study Overview
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Brief Summary
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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.

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

Conditions
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Endometrial Cancer, Extreme Obesity

Intervention / Treatment
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* Procedure: Transvaginal natural orifice endoscopic surgery for endometrial cancer staging


Participation Criteria
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Eligibility Criteria
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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
Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| extremely obese patients with early-stage endometrial cancer<br> | Procedure: Transvaginal natural orifice endoscopic surgery for endometrial cancer staging<br>* Cases of extreme obese patients with early stage endometrial cancer who underwent v-NOTES<br>|

What is the study measuring?
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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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Early stage endometrial cancer, extreme obesity, transvaginal NOTES