Uterine Manipulator in Endometrial Cancer Surgery: Pro MUCEI Study

NCT05242276 | Recruiting FDA Device

• 1 other identifier: pro MUCEI (507-21/07/21)
• Study Type: observational
• Target: 1,200
• Locations: 1 country
• Sites: 1

Brief Summary

The uterine manipulator is a device commonly used in minimally invasive hysterectomy surgery for endometrial cancer. However, without substantial evidence to support its use, surgeons are required to make decisions about its use based only on their personal choice and surgical experience. A retrospective study demonstrated how uterine manipulator use in early-stage endometrial cancer (FIGO I-II) for minimally invasive surgery was associated with a worse oncologic outcome in patients with uterus-confined endometrial cancer (FIGO I-II) who underwent minimally invasive surgery. The main objective of this study is to prospectively confirm the results obtained retrospectively, assessing the relapse rate in these patients related to the use or not of a uterine manipulator during the endometrial surgery. Secondary, the presence of risk factors that contraindicate the use of the uterine manipulator will also be evaluated.

Conditions

Endometrial Cancer

Keywords

endometrial cancer; uterine manipulator

Outcome Measures

Primary Outcomes (1)

• Relapse rate

  To prospectively evaluate the relapse rate in patients undergoing surgery for apparently early-stage endometrial cancer (FIGO I-II) with minimally invasive surgery with or without the use of a uterine manipulator.

  2 years

Secondary Outcomes (7)

• Other oncological outcomes

  3 years

• Relapse pattern

  3 years

• Surgical specimen variables

  1 year

• Treatment data

  1 year

• Pathology data

  1 year

Study Arms (2)

uterine manipulator cohort

Patients with early-stage endometrial cancer who have performed a hysterectomy with a uterine manipulator to mobilize the uterus during the surgery.

Device: USE OF UTERINE MANIPULATOR DURING THE HYSTERECTOMY

no uterine manipulator cohort

Patients with early-stage endometrial cancer who have performed a hysterectomy without a uterine manipulator to mobilize the uterus during the surgery.

Interventions

USE OF UTERINE MANIPULATOR DURING THE HYSTERECTOMY DEVICE

The uterine manipulator is a device commonly used in minimally invasive hysterectomy surgery for endometrial cancer. However, without substantial evidence to support its use, surgeons are required to make decisions about its use based only on their personal choice and surgical experience. . It is inserted vaginally through the cervical canal into the endometrial cavity. The uterine manipulator facilitates the uterus mobilization during the surgery, generating tension on the main supporting elements of the uterus to improve surgical field exposure and provide a landmark for the colpotomy.

uterine manipulator cohort

Eligibility Criteria

• Gender Eligibility Details: Female sex is the eligible gender because endometrial cancer is an exclusive women disease
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

All patients older than 18 years undergoing surgery in an apparently early stage of endometrial cancer proposed by FIGO: total hysterectomy with double adnexectomy and evaluation of the lymph node status following recommendations for surgical staging by FIGO. Follow-up prospectively, gathering the necessary information already described in the previous sections.

You may qualify if:

• \- Women with endometrial cancer diagnosed with stage I-II.
• \- Previous pre-surgical biopsy with a diagnosis of endometrial cancer.
• \- The surgery has been performed and there are complete data on surgery, pathological anatomy, and follow-up of at least 2 years.

You may not qualify if:

• Any patient with suspected disease beyond the uterus in the preoperative assessment or confirmed during surgical exploration. Cases without pathological confirmation of endometrial cancer in the final surgical specimen or final histology of atypical hyperplasia/endometrial intraepithelial neoplasia will not be accepted.
• Patients with open surgery, conversion to laparotomy, or vaginal hysterectomy alone will also be excluded.

Sponsors & Collaborators

• Instituto de Investigacion Sanitaria La Fe: lead

Study Sites (1)

Hospital universitario y politécnico La Fe

Valencia, 46026, Spain

RECRUITING

Related Publications (1)

• Padilla-Iserte P, Lago V, Tauste C, Diaz-Feijoo B, Gil-Moreno A, Oliver R, Coronado P, Martin-Salamanca MB, Pantoja-Garrido M, Marcos-Sanmartin J, Gilabert-Estelles J, Lorenzo C, Cazorla E, Roldan-Rivas F, Rodriguez-Hernandez JR, Sanchez L, Muruzabal JC, Hervas D, Domingo S; Spanish Society of Gynecology and Obstetrics Spanish Investigational Network Gynecologic Oncology Group. Impact of uterine manipulator on oncological outcome in endometrial cancer surgery. Am J Obstet Gynecol. 2021 Jan;224(1):65.e1-65.e11. doi: 10.1016/j.ajog.2020.07.025. Epub 2020 Jul 18.

  PMID: 32693096 RESULT

Related Links

• A video explaining the causes of the hypothesis about the impact of the uterine manipulator in endometrial cancer patients

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

• Pablo Padilla iserte, MD, PhD

  Hospital Universitario La Fe

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Pablo Padilla iserte, MD, PhD

CONTACT

961244000; oncogine_lafe@gva.es

Santiago Domingo del Pozo, MD, PhD

CONTACT

961244000; oncogine_lafe@gva.es

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Target Duration: 3 Years
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: January 21, 2022
• First Posted: February 16, 2022
• Study Start: March 20, 2022
• Primary Completion: March 20, 2024
• Study Completion: March 20, 2026
• Last Updated: October 10, 2023

Record last verified: 2023-10

Locations

ES (1)