Back to resultsUterine Manipulator Versus no Uterine Manipulator in Endometrial Cancer Trial (MANEC)
Primary Purpose
Endometrial Neoplasms
Status
Recruiting
Phase
Not Applicable
Locations
Italy
Study Type
Interventional
Intervention
Uterine manipulator use
Sponsored by
About this trial
This is an interventional treatment trial for Endometrial Neoplasms focused on measuring Endometrial Neoplasms, Uterine manipulator, Laparoscopic hysterectomy, Recurrence-free survival, Cause-specific survival, Overall survival, Oncologic outcomes
Eligibility Criteria
Inclusion Criteria: Diagnosis of Endometrial Cancer of any histology (including carcinosarcoma) and grade Planned surgical treatment including hysterectomy and bilateral salpingo-oophorectomy (ovarian preservation in selected patients is not an exclusion criterion) Age ≥ 18 years No preoperative evidence of extrauterine disease (Clinical stage IIIA, IIIB) No preoperative evidence of suspicious lymph nodes (Clinical stage IIIC) No preoperative evidence of distant metastasis (Clinical stage IV) Approved and signed informed consent Exclusion Criteria: Body Mass Index ≥ 45 Kg/m2 Neoadjuvant therapy Synchronous or previous (< 5 years) invasive cancer, not including non-melanoma skin cancer Fertility preservation World Health Organization performance score > 2 Uterine sarcoma Previous pelvic/abdominal radiotherapy, hormone therapy for cancer, chemotherapy, pelvic or paraaortic lymphadenectomy, or retroperitoneal surgery Inadequate bone marrow function (white blood cells <3·0×109/L, platelets <100×109/L) Inadequate liver function (bilirubin >1.5×upper normal limit [UNL], aspartate aminotransferase, and alanine aminotransferase >2.5 × UNL) Inadequate kidney function (creatinine clearance < 60 mL per min calculated according to Cockcroft-Gault 10 or < 50 mL per min Ethylenediaminetetraacetic acid clearance) Intraoperative evidence of stage IV disease
Sites / Locations
- AOUI Verona - University of Verona - Department of Obstetrics and GynecologyRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
Total hysterectomy with a uterine manipulator
Total hysterectomy without a uterine manipulator
Arm Description
Total hysterectomy with bilateral salpingo-oophorectomy performed with the use of a uterine manipulator during surgery.
Total hysterectomy with bilateral salpingo-oophorectomy performed without the use of a uterine manipulator during surgery.
Outcomes
Primary Outcome Measures
Recurrence-free survival
Any recurrence or death related to endometrial cancer (EC) or treatment
Secondary Outcome Measures
Cause-specific survival
Any death related to endometrial cancer (EC) or treatment
Overall survival
Any death for any cause
Site-specific recurrence-free survival
Any recurrence per site of first recurrence
Operative time
Time between first incision and skin closure
Intraoperative blood loss
Total blood aspirate during the surgical procedure
30-day post-surgical morbidity
Perioperative (intraoperative and postoperative) complications graded based on the Clavien-Dindo classification
Lymphovascular space invasion
Presence of lymphovascular space invasion at definitive pathology
Peritoneal cytology
Presence of positive peritoneal cytology at definitive pathology
Quality of life indexes
The Functional Assessment of Cancer Therapy - General (FACT-G) - A 27-item questionnaire designed to measure four domains of Health-Related Quality of Life in cancer patients: Physical, social, emotional, and functional well-being. Score range 0-108. The higher the score, the better the Quality of Life.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05687084
Brief Title
Uterine Manipulator Versus no Uterine Manipulator in Endometrial Cancer Trial
Acronym
MANEC
Official Title
Randomized Controlled Trial on the Oncologic Outcomes of Use Versus Not Use of the Uterine Manipulator in the Surgical Treatment of Apparent Uterine-confined Endometrial Carcinoma
Study Type
Interventional
2. Study Status
Record Verification Date
April 2023
Overall Recruitment Status
Recruiting
Study Start Date
January 16, 2023 (Actual)
Primary Completion Date
December 31, 2031 (Anticipated)
Study Completion Date
December 31, 2031 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Universita di Verona
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
Minimally invasive surgery is the recommended approach in endometrial cancer (EC) patients based on the results of two randomized controlled trials, given its advantages without compromised oncologic outcomes. The uterine manipulator is commonly used in benign and malignant pathologies to perform a laparoscopic or robotic hysterectomy. However, although regularly used, the uterine manipulator adoption in EC is a controversial technical aspect due to the raised concerns regarding the possible risk of disruption of the tumor mass, the spread of malignant cells, and seeding of the disease, particularly at the level of the vaginal cuff or spread of tumor cells, with increased risk of recurrence and death due to EC. On that basis, given that hysterectomy without a uterine manipulator is feasible, only a randomized controlled trial comparing oncologic outcomes in EC patients after use versus not use of the uterine manipulator will be able to provide high-quality evidence to answer this critical question and allow or exclude the use of a uterine manipulator during minimally invasive hysterectomy for EC.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Endometrial Neoplasms
Keywords
Endometrial Neoplasms, Uterine manipulator, Laparoscopic hysterectomy, Recurrence-free survival, Cause-specific survival, Overall survival, Oncologic outcomes
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Multicenter, parallel arms, open-label, randomized controlled trial.
Masking
None (Open Label)
Allocation
Randomized
Enrollment
1030 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Total hysterectomy with a uterine manipulator
Arm Type
Experimental
Arm Description
Total hysterectomy with bilateral salpingo-oophorectomy performed with the use of a uterine manipulator during surgery.
Arm Title
Total hysterectomy without a uterine manipulator
Arm Type
No Intervention
Arm Description
Total hysterectomy with bilateral salpingo-oophorectomy performed without the use of a uterine manipulator during surgery.
Intervention Type
Device
Intervention Name(s)
Uterine manipulator use
Intervention Description
After peritoneal washing, the uterine manipulator will be inserted into the uterus to assist in the procedure of total hysterectomy.
Primary Outcome Measure Information:
Title
Recurrence-free survival
Description
Any recurrence or death related to endometrial cancer (EC) or treatment
Time Frame
Each follow-up visit, up to 4 years from the day of surgery
Secondary Outcome Measure Information:
Title
Cause-specific survival
Description
Any death related to endometrial cancer (EC) or treatment
Time Frame
Each follow-up visit, up to 4 years from the day of surgery
Title
Overall survival
Description
Any death for any cause
Time Frame
Each follow-up visit, up to 4 years from the day of surgery
Title
Site-specific recurrence-free survival
Description
Any recurrence per site of first recurrence
Time Frame
Each follow-up visit, up to 4 years from the day of surgery
Title
Operative time
Description
Time between first incision and skin closure
Time Frame
Day of surgery
Title
Intraoperative blood loss
Description
Total blood aspirate during the surgical procedure
Time Frame
Day of surgery
Title
30-day post-surgical morbidity
Description
Perioperative (intraoperative and postoperative) complications graded based on the Clavien-Dindo classification
Time Frame
30 days after surgery
Title
Lymphovascular space invasion
Description
Presence of lymphovascular space invasion at definitive pathology
Time Frame
Day of surgery
Title
Peritoneal cytology
Description
Presence of positive peritoneal cytology at definitive pathology
Time Frame
Day of surgery
Title
Quality of life indexes
Description
The Functional Assessment of Cancer Therapy - General (FACT-G) - A 27-item questionnaire designed to measure four domains of Health-Related Quality of Life in cancer patients: Physical, social, emotional, and functional well-being. Score range 0-108. The higher the score, the better the Quality of Life.
Time Frame
Each follow-up visit, up to 4 years from the day of surgery
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
100 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Diagnosis of Endometrial Cancer of any histology (including carcinosarcoma) and grade
Planned surgical treatment including hysterectomy and bilateral salpingo-oophorectomy (ovarian preservation in selected patients is not an exclusion criterion)
Age ≥ 18 years
No preoperative evidence of extrauterine disease (Clinical stage IIIA, IIIB)
No preoperative evidence of suspicious lymph nodes (Clinical stage IIIC)
No preoperative evidence of distant metastasis (Clinical stage IV)
Approved and signed informed consent
Exclusion Criteria:
Body Mass Index ≥ 45 Kg/m2
Neoadjuvant therapy
Synchronous or previous (< 5 years) invasive cancer, not including non-melanoma skin cancer
Fertility preservation
World Health Organization performance score > 2
Uterine sarcoma
Previous pelvic/abdominal radiotherapy, hormone therapy for cancer, chemotherapy, pelvic or paraaortic lymphadenectomy, or retroperitoneal surgery
Inadequate bone marrow function (white blood cells <3·0×109/L, platelets <100×109/L)
Inadequate liver function (bilirubin >1.5×upper normal limit [UNL], aspartate aminotransferase, and alanine aminotransferase >2.5 × UNL)
Inadequate kidney function (creatinine clearance < 60 mL per min calculated according to Cockcroft-Gault 10 or < 50 mL per min Ethylenediaminetetraacetic acid clearance)
Intraoperative evidence of stage IV disease
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Stefano Uccella, MD, PhD
Phone
0039 045 812 2720
Email
stefano.uccella@univr.it
First Name & Middle Initial & Last Name or Official Title & Degree
Simone Garzon, MD
Phone
0039 045 812 2720
Email
simone.garzon@univr.it
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Stefano Uccella, MD, PhD
Organizational Affiliation
AOUI Verona - University of Verona
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Simone Garzon, MD
Organizational Affiliation
AOUI Verona - University of Verona
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Pier Carlo Zorzato, MD
Organizational Affiliation
AOUI Verona - University of Verona
Official's Role
Principal Investigator
Facility Information:
Facility Name
AOUI Verona - University of Verona - Department of Obstetrics and Gynecology
City
Verona
ZIP/Postal Code
37125
Country
Italy
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Simone Garzon, MD
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
33397713
Citation
Concin N, Matias-Guiu X, Vergote I, Cibula D, Mirza MR, Marnitz S, Ledermann J, Bosse T, Chargari C, Fagotti A, Fotopoulou C, Gonzalez Martin A, Lax S, Lorusso D, Marth C, Morice P, Nout RA, O'Donnell D, Querleu D, Raspollini MR, Sehouli J, Sturdza A, Taylor A, Westermann A, Wimberger P, Colombo N, Planchamp F, Creutzberg CL. ESGO/ESTRO/ESP guidelines for the management of patients with endometrial carcinoma. Int J Gynecol Cancer. 2021 Jan;31(1):12-39. doi: 10.1136/ijgc-2020-002230. Epub 2020 Dec 18.
Results Reference
background
PubMed Identifier
25967852
Citation
van den Haak L, Alleblas C, Nieboer TE, Rhemrev JP, Jansen FW. Efficacy and safety of uterine manipulators in laparoscopic surgery: a review. Arch Gynecol Obstet. 2015 Nov;292(5):1003-11. doi: 10.1007/s00404-015-3727-9. Epub 2015 May 13.
Results Reference
background
PubMed Identifier
33207238
Citation
Uccella S, Cianci S, Gueli Alletti S. Uterine manipulator in endometrial cancer: we are still far from the answer. Am J Obstet Gynecol. 2021 Mar;224(3):332. doi: 10.1016/j.ajog.2020.09.049. Epub 2020 Nov 15. No abstract available.
Results Reference
background
PubMed Identifier
28147240
Citation
Uccella S, Bonzini M, Malzoni M, Fanfani F, Palomba S, Aletti G, Corrado G, Ceccaroni M, Seracchioli R, Shakir F, Ferrero A, Berretta R, Tinelli R, Vizza E, Roviglione G, Casarella L, Volpi E, Cicinelli E, Scambia G, Ghezzi F. The effect of a uterine manipulator on the recurrence and mortality of endometrial cancer: a multi-centric study by the Italian Society of Gynecological Endoscopy. Am J Obstet Gynecol. 2017 Jun;216(6):592.e1-592.e11. doi: 10.1016/j.ajog.2017.01.027. Epub 2017 Jan 29.
Results Reference
background
PubMed Identifier
32693096
Citation
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.
Results Reference
background
Learn more about this trial
Uterine Manipulator Versus no Uterine Manipulator in Endometrial Cancer Trial
We'll reach out to this number within 24 hrs