Cited 10 times in
Safety and efficacy study of laparoscopic or robotic radical surgery using an endoscopic stapler for inhibiting tumour spillage of cervical malignant neoplasms evaluating survival (SOLUTION): a multi-centre, open-label, single-arm, phase II trial protocol
DC Field | Value | Language |
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dc.contributor.author | 남은지 | - |
dc.date.accessioned | 2022-05-09T17:12:41Z | - |
dc.date.available | 2022-05-09T17:12:41Z | - |
dc.date.issued | 2022-03 | - |
dc.identifier.uri | https://ir.ymlib.yonsei.ac.kr/handle/22282913/188440 | - |
dc.description.abstract | Background: The Laparoscopic Approach to Cervical Cancer trial and Surveillance, Epidemiology, and End Results program database study demonstrated that minimally invasive radical hysterectomy was inferior to abdominal radical hysterectomy in terms of disease recurrence and survival. Among risk factors related to poor prognosis after minimally invasive surgery (MIS), tumour spillage during intracorporeal colpotomy became a significant issue. Thus, we designed this trial to evaluate the efficacy and safety of minimally invasive radical hysterectomy using an endoscopic stapler for early-stage cervical cancer. Methods: This trial is a prospective, multi-centre, open-label, single-arm, non-inferiority phase II study. The nine organisations will participate in this trial after the approval of the institutional review board. Major eligibility criteria include women aged 20 years or older with cervical cancer stage IB1 squamous cell carcinoma, adenocarcinoma, or adenosquamous carcinoma according to the revised 2009 FIGO staging system who will undergo type B2 or C hysterectomy by MIS. The primary endpoint is the 4.5-year disease-free survival (DFS) rate between abdominal radical hysterectomy and MIS using an endoscopic stapler. For calculating the sample size, we hypothesised that the 4.5-year DFS rate after MIS using an endoscopic stapler is assumed to be the same after abdominal radical hysterectomy at 90.9%, and the non-inferiority margin was 7.2%. When we consider a three-year accrual and 4.5-year follow-up, at least 13 events must happen, requiring a total of 111 patients assuming a statistical power of 80% and the one-tailed test of 5% significance. A total of 124 patients is needed, considering a drop-out rate of 10%. Discussion: We expect intracorporeal colpotomy using an endoscopic stapler may prevent tumour spillage during MIS for stage IB1 cervical cancer, showing a comparable prognosis with abdominal radical surgery. Trial registration: ClinicalTrials.gov ; NCT04370496 ; registration date, May 2020. | - |
dc.description.statementOfResponsibility | open | - |
dc.language | English | - |
dc.publisher | BioMed Central | - |
dc.relation.isPartOf | BMC CANCER | - |
dc.rights | CC BY-NC-ND 2.0 KR | - |
dc.subject.MESH | Adult | - |
dc.subject.MESH | Clinical Trials, Phase II as Topic | - |
dc.subject.MESH | Female | - |
dc.subject.MESH | Humans | - |
dc.subject.MESH | Laparoscopy* / adverse effects | - |
dc.subject.MESH | Laparoscopy* / methods | - |
dc.subject.MESH | Multicenter Studies as Topic | - |
dc.subject.MESH | Neoplasm Recurrence, Local / pathology | - |
dc.subject.MESH | Neoplasm Staging | - |
dc.subject.MESH | Prospective Studies | - |
dc.subject.MESH | Robotic Surgical Procedures* / adverse effects | - |
dc.subject.MESH | Robotic Surgical Procedures* / methods | - |
dc.subject.MESH | Uterine Cervical Neoplasms* / pathology | - |
dc.subject.MESH | Young Adult | - |
dc.title | Safety and efficacy study of laparoscopic or robotic radical surgery using an endoscopic stapler for inhibiting tumour spillage of cervical malignant neoplasms evaluating survival (SOLUTION): a multi-centre, open-label, single-arm, phase II trial protocol | - |
dc.type | Article | - |
dc.contributor.college | College of Medicine (의과대학) | - |
dc.contributor.department | Dept. of Obstetrics and Gynecology (산부인과학교실) | - |
dc.contributor.googleauthor | Soo Jin Park | - |
dc.contributor.googleauthor | Tae Wook Kong | - |
dc.contributor.googleauthor | Taehun Kim | - |
dc.contributor.googleauthor | Maria Lee | - |
dc.contributor.googleauthor | Chel Hun Choi | - |
dc.contributor.googleauthor | Seung-Hyuk Shim | - |
dc.contributor.googleauthor | Ga Won Yim | - |
dc.contributor.googleauthor | Seungmee Lee | - |
dc.contributor.googleauthor | Eun Ji Lee | - |
dc.contributor.googleauthor | Myong Cheol Lim | - |
dc.contributor.googleauthor | Suk-Joon Chang | - |
dc.contributor.googleauthor | Sung Jong Lee | - |
dc.contributor.googleauthor | San Hui Lee | - |
dc.contributor.googleauthor | Taejong Song | - |
dc.contributor.googleauthor | Yoo-Young Lee | - |
dc.contributor.googleauthor | Hee Seung Kim | - |
dc.contributor.googleauthor | Eun Ji Nam | - |
dc.identifier.doi | 10.1186/s12885-022-09429-z | - |
dc.contributor.localId | A01262 | - |
dc.relation.journalcode | J00351 | - |
dc.identifier.eissn | 1471-2407 | - |
dc.identifier.pmid | 35346103 | - |
dc.subject.keyword | Cervical cancer | - |
dc.subject.keyword | Endoscopic stapler | - |
dc.subject.keyword | Minimally invasive surgery | - |
dc.subject.keyword | Recurrence | - |
dc.subject.keyword | Survival | - |
dc.contributor.alternativeName | Nam, Eun Ji | - |
dc.contributor.affiliatedAuthor | 남은지 | - |
dc.citation.volume | 22 | - |
dc.citation.startPage | 331 | - |
dc.identifier.bibliographicCitation | BMC CANCER, Vol.22 : 331, 2022-03 | - |
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