Ignite Creation Date:
2024-05-19 @ 5:34 PM
Last Modification Date:
2024-10-26 @ 3:29 PM
Study NCT ID:
NCT06416748
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-05-16
First Post:
2024-05-11
Brief Title:
Minimally Invasive Simple Hysterectomy in Low Risk Cervical Cancer
Sponsor:
Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Organization:
Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Study Overview
Official Title:
Minimally Invasive Simple Hysterectomy in Low Risk Cervical Cancer
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
LASH
Brief Summary:
The rationale of the present study is to assess the safety of the minimally invasive surgery approach in patients meeting the SHAPE trial inclusion criteriaThe SHAPE trial was designed to answer the clinical question of whether simple hysterectomy could be performed instead of radical hysterectomy in low-risk early stage cervical cancer but not the surgical approach The favorable oncological outcome observed in SHAPE despite 75 of patients were treated with minimally invasive approach suggests that this approach may be safe However the trial was not designed to analyze oncological outcomes from surgical approach
Detailed Description:
The Laparoscopic Approach to Cervical Cancer LACC Trial showed that minimally invasive radical hysterectomy was associated with lower rates of disease-free survival and overall survival than open abdominal radical hysterectomy among women with early-stage cervical cancer Since then the standard of care in terms of surgical approach to radical hysterectomy has been considered the laparotomy More recently the SHAPE trial results were presented showing that in patients with low-risk cervical cancer defined as FIGO 2018 stage IA2 and IB1 up to 2 cm with limited stromal invasion 10 mm on LEEPcone and 50 depth on MRI simple hysterectomy was not inferior to radical hysterectomy for what concerned pelvic recurrence with less complications and better quality of life However SHAPE trial was not designed to assess the surgical approach
The rationale of the present study is to assess the safety of the minimally invasive surgery approach in patients meeting the SHAPE trial inclusion criteria
The rationale of the present study is to assess the safety of the minimally invasive surgery approach in patients meeting the SHAPE trial inclusion criteria
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None