NCT04240730

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
6

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Jan 2019

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2019

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 30, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 30, 2019

Completed
7 months until next milestone

First Submitted

Initial submission to the registry

January 22, 2020

Completed
5 days until next milestone

First Posted

Study publicly available on registry

January 27, 2020

Completed
Last Updated

February 11, 2020

Status Verified

February 1, 2020

Enrollment Period

6 months

First QC Date

January 22, 2020

Last Update Submit

February 7, 2020

Conditions

Endometrial CancerExtreme Obesity

Keywords

Early stage endometrial cancerextreme obesitytransvaginal NOTES

Outcome Measures

Primary Outcomes (8)

  • 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

Study Arms (1)

extremely obese patients with early-stage endometrial cancer

Procedure: Transvaginal natural orifice endoscopic surgery for endometrial cancer staging

Interventions

Transvaginal natural orifice endoscopic surgery for endometrial cancer stagingPROCEDURE

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

extremely obese patients with early-stage endometrial cancer

Eligibility Criteria

Sexfemale
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Extreme obese patients with early stage type-1 endometrial cancer

You may qualify if:

  • Extreme obese patients
  • Early stage type-1 endometrial cancer proved by endometrial sampling

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

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

Istanbul, Kartal, 34890, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Endometrial NeoplasmsObesity, Morbid

Condition Hierarchy (Ancestors)

Uterine NeoplasmsGenital Neoplasms, FemaleUrogenital NeoplasmsNeoplasms by SiteNeoplasmsUterine DiseasesGenital Diseases, FemaleFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesGenital DiseasesObesityOverweightOvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Ahmet Kale, Prof.Dr.

    Kartal Dr.Lutfi Kirdar Research and Training Hospital

    STUDY DIRECTOR

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER GOV
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Head of Gynecologic Oncology

Study Record Dates

First Submitted

January 22, 2020

First Posted

January 27, 2020

Study Start

January 1, 2019

Primary Completion

June 30, 2019

Study Completion

June 30, 2019

Last Updated

February 11, 2020

Record last verified: 2020-02

Data Sharing

IPD Sharing
Will not share

Locations

TU(1)