CI

At a glance

ClinicalIndex Comparison Record
N/ARecruiting· 124 target
Drug / intervention
Minimally invasive surgery using endoscopic staplerprocedure
Likely dose
Not stated in record
Key inclusion· 7
  • ✓Females aged 20 years or older
  • ✓Histologically confirmed squamous cell carcinoma, adenocarcinoma, or adenosquamous carcinoma of uterine cervix
  • ✓FIGO stage IB1 with stromal invasion >5 mm or lesion size 7 mm to ≤4 cm
  • ✓Undergoing type B or C hysterectomy (Querleu-Morrow classification)
Key exclusion· 11
  • ✕Any histological type other than squamous cell carcinoma, adenocarcinoma, or adenosquamous carcinoma
  • ✕Tumor size greater than 4 cm
  • ✕FIGO stage less than IA2 or greater than IB2
  • ✕Evidence of metastatic disease, enlarged pelvic/aortic lymph nodes >2 cm, or histologically positive lymph nodes

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT04370496
NCT04370496N/ARecruitingOn TrackUpdated 36mo ago
Long Recruiting
CompareCT.gov

Safety Of Laparoscopic or Robotic Radical Hysterectomy Using Endoscopic sTapler for Inhibiting tumOr Spillage of Cervical Neoplasms (SOLUTION): a Phase II Study

Seoul National University Hospital·interventional·Posted May 1, 2020·Updated Jun 26, 2023

In Brief

A clinical study evaluating Minimally invasive surgery using endoscopic stapler for Cervical Cancer and 2 related conditions. Currently recruiting, targeting 124 participants across 3 sites.

Detailed Summary

The SOLUTION trial aims to show the efficacy and safety of performing radical hysterectomy by minimally invasive surgery using an endoscopic stapler in patients with cervical cancer stage IB1 (FIGO staging 2009) and thus to prove that minimally invasive surgery is non-inferior to open surgery.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsCervical Cancer, Cervical Cancer Stage IB1, Minimally Invasive Surgery
CountriesSouth Korea
CollaboratorsJohnson & Johnson

Timeline

N/ARecruiting
202120222023202420252026202720282029
First PostedMay 1, 2020
Enrollment StartJul 2, 2020
Primary CompletionDec 31, 2028
TodayJul 2, 2026
Enrollment to primary: 8.5 yearsPosted 6.2 years agoPrimary completion in 2.5 years

Interventions

Minimally invasive surgery using endoscopic staplerprocedure

Radical hysterectomy by minimally invasive surgery (laparoscopic or robotic) will be done with the help of an endoscopic stapler in cutting and suturing the uterine cervix.