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Completed

NCT Number: NCT04240730

Transvaginal Natural Orifice Endoscopic Surgery 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.

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Key information

Conditions

Endometrial Cancer Body Weight Endometrial Neoplasms Extreme Obesity Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Genital Diseases Genital Diseases, Female Genital Neoplasms, Female Neoplasms Neoplasms by Site Nutrition Disorders Nutritional and Metabolic Diseases Obesity Obesity, Morbid Overnutrition Overweight Pathological Conditions, Signs and Symptoms Signs and Symptoms Urogenital Diseases Urogenital Neoplasms Uterine Diseases Uterine Neoplasms

Sex eligibility

Female

Study type

Observational

Primary location

University of Health Sciences Kartal Dr. Lütfi Kirdar Training and Research Hospital

Istanbul, Kartal, 34890, Turkey (Türkiye)

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Transvaginal natural orifice endoscopic surgery for endometrial cancer staging

Procedure

Cases of extreme obese patients with early stage endometrial cancer who underwent v-NOTES

Primary outcomes

  1. Operating time

    Time frame: 4 hours

    The operation time in minutes. The operation time was from commencement of the colpotomy incision to vaginal closure.

  2. Any conversion to conventional laparoscopy or laparotomy

    Time frame: 4 hours

    Number of the patients whose surgery couldn't completed by transvaginal natural orifice surgery.

  3. Pre- and post-operative hemoglobin levels

    Time frame: 24 hours

    Hemoglobin levels in g/dL. Hemoglobin levels of the patients before surgery and on postoperative day 1.

  4. Length of hospital stay

    Time frame: 2 day

    Length of hospital stay in days. Duration of hospital stay was calculated from the patient's admission until hospital discharge.

  5. Any intra- or post-operative complication

    Time frame: 6 months

    Number of the patients who have any complication during or after transvaginal natural orifice surgery.

  6. pain scores

    Time frame: 6 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).

  7. pain scores

    Time frame: 12 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).

  8. pain scores

    Time frame: 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).

Sponsors and collaborators

Lead sponsor

Dr. Lutfi Kirdar Kartal Training and Research Hospital

Other Gov

Registry information

Official study title

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

Important dates

Study start
2019
Primary completion
2019
Study completion
2019
First posted
Jan 27, 2020
Registry last updated
Feb 11, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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