Effect of Uterine Manipulator on Recurrence and Mortality of Endometrial Cancer

NCT02943811 | Completed

• 1 other identifier: 521
• Study Type: observational
• Target: 951
• Locations: 0 countries
• Sites: N/A

Brief 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

Conditions

Endometrial Cancer

Keywords

endometrial cancer; survival; uterine manipulator

Outcome Measures

Primary Outcomes (1)

• Disease recurrence

  Relapse of disease during follow-up

  4 years

Secondary Outcomes (2)

• disease specific survival

  4 years

• overall survival

  4 years

Study Arms (2)

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

UTERINE MANIPULATOR DEVICE

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

MANIPULATOR

Eligibility Criteria

• Age: 18 Years - 100 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Women affected by early endometrial cancer

You may qualify if:

• Clinical stage I endometrial cancer
• Laparoscopic operation

You may not qualify if:

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

Sponsors & Collaborators

• Università degli Studi dell'Insubria: lead

Related Publications (2)

• 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.

  PMID: 27518143 BACKGROUND

• 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.

  PMID: 27312035 BACKGROUND

MeSH Terms

Conditions

Endometrial Neoplasms

Condition Hierarchy (Ancestors)

Uterine Neoplasms; Genital Neoplasms, Female; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Uterine Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases

Study Officials

• Stefano Uccella

  Università degli Studi dell'Insubria

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Doctor

Study Record Dates

• First Submitted: October 22, 2016
• First Posted: October 25, 2016
• Study Start: October 1, 2016
• Primary Completion: October 1, 2016
• Study Completion: October 1, 2016
• Last Updated: November 15, 2016

Record last verified: 2016-11

Data Sharing

• IPD Sharing: Will not share