Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04240730
Recruitment Status : Completed
First Posted : January 27, 2020
Last Update Posted : February 11, 2020
Sponsor:
Information provided by (Responsible Party):
Emre Mat, 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.

Condition or disease Intervention/treatment
Endometrial Cancer Extreme Obesity Procedure: Transvaginal natural orifice endoscopic surgery for endometrial cancer staging

Layout table for study information
Study Type : Observational
Actual Enrollment : 6 participants
Observational Model: Case-Only
Time Perspective: Retrospective
Official Title: Transvaginal Natural Orifice Endoscopic Surgery (v-NOTES) for Extremely Obese Patients With Early-stage Endometrial Cancer
Actual Study Start Date : January 1, 2019
Actual Primary Completion Date : June 30, 2019
Actual Study Completion Date : June 30, 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Endoscopy

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




Primary Outcome Measures :
  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).



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Extreme obese patients with early stage type-1 endometrial cancer
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04240730


Locations
Layout table for location information
Turkey
University of Health Sciences Kartal Dr. Lütfi Kirdar Training and Research Hospital
Istanbul, Kartal, Turkey, 34890
Sponsors and Collaborators
Dr. Lutfi Kirdar Kartal Training and Research Hospital
Investigators
Layout table for investigator information
Study Director: Ahmet Kale, Prof.Dr. Kartal Dr.Lutfi Kirdar Research and Training Hospital
Layout table for additonal information
Responsible Party: Emre Mat, Head of Gynecologic Oncology, Dr. Lutfi Kirdar Kartal Training and Research Hospital
ClinicalTrials.gov Identifier: NCT04240730    
Other Study ID Numbers: v-NOTESandobesity
First Posted: January 27, 2020    Key Record Dates
Last Update Posted: February 11, 2020
Last Verified: February 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Emre Mat, Dr. Lutfi Kirdar Kartal Training and Research Hospital:
Early stage endometrial cancer
extreme obesity
transvaginal NOTES
Additional relevant MeSH terms:
Layout table for MeSH terms
Endometrial Neoplasms
Uterine Neoplasms
Genital Neoplasms, Female
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Uterine Diseases
Genital Diseases, Female