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CompletedNCT02943811Updated Nov 15, 2016

Effect of Uterine Manipulator on Recurrence and Mortality of Endometrial Cancer

An observational study in Endometrial Cancer, sponsored by Università degli Studi dell'Insubria. Completed. Open to female participants aged 18 Years to 100 Years. Per ClinicalTrials.gov, last updated 2016-11-15.

Sponsored by Università degli Studi dell'Insubria · Observational

Study type
Observational
Model
Case-control
Time perspective
Retrospective
Enrollment
951
Ages
18 Years to 100 Years
Sex
Female
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Study summary

The investigators sought to retrospectively assess whether the use of a intrauterine device to manipulate the uterus does affect the long-term oncologic outcomes of patients operated by laparoscopy for endometrial cancer

Read the detailed description

The investigators retrospectively collected data regarding patients who received operation by laparoscopy for presumed clinical stage I endometrial cancer. The subjects were then stratified according to the use or not of the uterine manipulator. The investigators also considered the actual type of manipulator used. Then disease-free, disease-specific and overall survival were evaluated, as well as all the possible factors associated with prognosis.

Data were retrieved from specifically designed research quality internal surgical databases, prospectively updated by trained residents on a regular basis, in order to capture all the possible surgical and follow-up data.

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Conditions studied

  • Endometrial Cancer

Keywords

  • endometrial cancer
  • survival
  • uterine manipulator
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In context

Endometrial Neoplasms

1,325 studies on the registry are indexed under Endometrial Neoplasms; 447 are open to participants now.

This study's enrollment of 951 is above the median of 179 across 321 observational studies indexed under Endometrial Neoplasms.

Browse Endometrial Neoplasms studies →

Lead sponsor

Università degli Studi dell'Insubria is the lead sponsor of 67 studies on the registry; 8 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years to 100 Years
Sexes eligible
Female
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

Women affected by early endometrial cancer

Inclusion criteria

  • Clinical stage I endometrial cancer
  • Laparoscopic operation

Exclusion criteria

Exclusion Criteria:

  • post-operative oncologic follow-up \< 12 months
  • extra-uterine evidence of disease
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Study design

Observational model
Case-control
Time perspective
Retrospective
Enrollment
951 participants (actual)
Patient registry
No

Groups and cohorts

  • MANIPULATOR

    Patients who were operated for endometrial cancer by laparoscopy with the use of a uterine manipulator

    Device: UTERINE MANIPULATOR

  • NO MANIPULATOR

    Patients who were operated for endometrial cancer by laparoscopy without the use of a uterine manipulator

Interventions

  • DeviceUTERINE MANIPULATOR

    Patients were operated laparoscopically with the aid or not of an intrauterine probe to manipulate the uterus

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What researchers measure

Primary outcomes

  1. Disease recurrence

    Relapse of disease during follow-up

    Time frame: 4 years

Secondary outcomes

  1. disease specific survival

    Kaplan Meyer curves and Log-rank test to explore disease-specific survival

    Time frame: 4 years

  2. overall survival

    Kaplan Meyer curves and Log-rank test to explore overall survival

    Time frame: 4 years

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Study locations

No study locations are listed for this record.

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References and documents

Publications

  • Marcos-Sanmartin J, Lopez Fernandez JA, Sanchez-Paya J, Pinero-Sanchez OC, Roman-Sanchez MJ, Quijada-Cazorla MA, Candela-Hidalgo MA, Martinez-Escoriza JC. Does the Type of Surgical Approach and the Use of Uterine Manipulators Influence the Disease-Free Survival and Recurrence Rates in Early-Stage Endometrial Cancer? Int J Gynecol Cancer. 2016 Nov;26(9):1722-1726. doi: 10.1097/IGC.0000000000000808. PubMed 27518143 ↗
  • Tinelli R, Cicinelli E, Tinelli A, Bettocchi S, Angioni S, Litta P. Laparoscopic treatment of early-stage endometrial cancer with and without uterine manipulator: Our experience and review of literature. Surg Oncol. 2016 Jun;25(2):98-103. doi: 10.1016/j.suronc.2016.03.005. Epub 2016 Mar 23. PubMed 27312035 ↗

Individual participant data

Plan to share: No

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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Nov 15, 2016, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT02943811
Lead sponsor
Università degli Studi dell'Insubria
Responsible party
Stefano Uccella (Doctor, Università degli Studi dell'Insubria) — Principal investigator
First posted
Oct 25, 2016
Start date
Oct 2016
Primary completion
Oct 2016
Completion
Oct 2016
Last update
Nov 15, 2016

Study contacts

Stefano Uccella
principal investigator · Università degli Studi dell'Insubria

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Nov 2016. You cannot join it, but the record below documents what was studied.

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