Effect of Uterine Manipulator on Recurrence and Mortality of Endometrial Cancer

Endometrial Cancer Clinical Trial

Official title:

Effect of Uterine Manipulator on Recurrence and Mortality of Endometrial Cancer: a Multi-centric Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02943811
• Other study ID #: 521
• Status: Completed
• Phase: N/A
• First received: October 22, 2016
• Last updated: November 14, 2016
• Start date: October 2016
• Est. completion date: October 2016

Study information

• Verified date: November 2016
• Source: Università degli Studi dell'Insubria
• Contact: n/a
• Is FDA regulated: No
• Health authority: Italy: Ethics Committee
• Study type: Observational

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 951
• Est. completion date: October 2016
• Est. primary completion date: October 2016
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 100 Years

Eligibility

Inclusion Criteria:

• Clinical stage I endometrial cancer

• Laparoscopic operation

Exclusion Criteria:

• post-operative oncologic follow-up < 12 months

• extra-uterine evidence of disease

Study Design

Observational Model: Case Control, Time Perspective: Retrospective

Related Conditions & MeSH terms

• Endometrial Cancer
• Endometrial Neoplasms
• Recurrence

Intervention

Device:
• UTERINE MANIPULATOR
Patients were operated laparoscopically with the aid or not of an intrauterine probe to manipulate the uterus

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Università degli Studi dell'Insubria

References & Publications (2)

Marcos-Sanmartín J, López Fernández JA, Sánchez-Payá J, Piñero-Sánchez ÓC, Román-Sánchez MJ, Quijada-Cazorla MA, Candela-Hidalgo MA, Martínez-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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Disease recurrence	Relapse of disease during follow-up	4 years	No
Secondary	disease specific survival	Kaplan Meyer curves and Log-rank test to explore disease-specific survival	4 years	No
Secondary	overall survival	Kaplan Meyer curves and Log-rank test to explore overall survival	4 years	No