Effect of Uterine Manipulator on Recurrence and Mortality of Endometrial Cancer

NCT ID: NCT02943811

Last Updated: 2016-11-15

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

951 participants

Study Classification

OBSERVATIONAL

Study Start Date

2016-10-31

Study Completion Date

2016-10-31

Brief Summary

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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

Detailed Description

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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.

Conditions

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Endometrial Cancer

Keywords

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endometrial cancer survival uterine manipulator

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

RETROSPECTIVE

Study Groups

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MANIPULATOR

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

UTERINE MANIPULATOR

Intervention Type DEVICE

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

NO MANIPULATOR

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

No interventions assigned to this group

Interventions

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UTERINE MANIPULATOR

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

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

* Clinical stage I endometrial cancer
* Laparoscopic operation

Exclusion Criteria

* post-operative oncologic follow-up \< 12 months
* extra-uterine evidence of disease
Minimum Eligible Age

18 Years

Maximum Eligible Age

100 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Università degli Studi dell'Insubria

OTHER

Sponsor Role lead

Responsible Party

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Stefano Uccella

Doctor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Stefano Uccella

Role: PRINCIPAL_INVESTIGATOR

Università degli Studi dell'Insubria

References

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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.

Reference Type BACKGROUND
PMID: 27518143 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 27312035 (View on PubMed)

Other Identifiers

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521

Identifier Type: -

Identifier Source: org_study_id