Clinical trial · Observational
Research on Laparoscopic Fertility-Sparing Surgery in Early-Stage Cervical Cancer
Oncological and Obstetrical Outcomes for Fertility Preservation in Early Cervical Cancer Patient With Laparoscopic-assisted Vaginal Radical Trachelectomy
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
Purpose: To evaluate the oncological and obstetrical outcomes of women with early-stage cervical cancer who underwent laparoscopic-assisted vaginal radical trachelectomy (LAVRT). All women with early-stage cervical cancer who planned to undergo fertility-preserved radical trachelectomy. The obstetric outcome evaluation was restricted to women with ≥12 months of follow-up and an active desire to conceive. The oncological outcome was evaluated in all patients. Statistical methods: Statistical analyses were performed using IBM SPSS Statistics, version 26. The t-test is used for analyzing the continuous variables and the chi-squared test for categorical variables.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Cervical Cancer | Malignant Cervical Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Received laparoscopic-assisted vaginal radical trachelectomy | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (0)
[]Primary outcomes (3)
- measure
- Progression-Free Survival
- timeFrame
- 5-10 years
- description
- the date of the treatment to the date of disease progression or death from any cause in the absence of progression
- measure
- Pregnancy rate after surgery
- timeFrame
- 5 years
- description
- Postoperative patients who have successfully conceived
- measure
- Recurrence rate
- timeFrame
- 20years
- description
- The ratio of recurrent patients to the total enrolled patients
Secondary outcomes (2)
- measure
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
- Maximum age
- 45 Years
Show eligibility criteria text
Inclusion Criteria: * (i) were younger than 45 years old; (ii) strong desired to preserve fertility; (iii) had International Federation of Gynecology and Obstetrics (FIGO) stage IA1 (with lymphovascular space invasion (LVSI) positivity) to IB2; (iv) pathologically confirmed invasive cervical cancer; (v)had histology indicative of squamous cell carcinoma, adenosquamous cancer or adenocarcinoma; (vi) lacked evidence of pelvic lymph node or distant metastasis according to pelvic MRI and serum tumor markers (SCC and CA125) levels. Exclusion Criteria: * (i) diagnosis of cervical gastric adenocarcinoma, cervical neuroendocrine carcinoma and other special types; (ii) invasion of cervical internal orifice; (iii) had contraindication of pregnancy; (iv) incomplete clinical data; (v) radiotherapy or hysterectomy was performed after diagnostic conization.
References
Publications (5)
- BACKGROUNDKyrgiou M, Mitra A, Paraskevaidis E. Fertility and Early Pregnancy Outcomes Following Conservative Treatment for Cervical Intraepithelial Neoplasia and Early Cervical Cancer. JAMA Oncol. 2016 Nov 1;2(11):1496-1498. doi: 10.1001/jamaoncol.2016.1839. PMID 27356074
- BACKGROUNDMartinelli F, Ditto A, Filippi F, Vinti D, Bogani G, Leone Roberti Maggiore U, Evangelista M, Signorelli M, Chiappa V, Lopez S, Somigliana E, Raspagliesi F. Conization and lymph node evaluation as a fertility-sparing treatment for early stage cervical cancer. Int J Gynecol Cancer. 2021 Mar;31(3):457-461. doi: 10.1136/ijgc-2020-001740. PMID 33649014
- BACKGROUNDKyrgiou M, Athanasiou A, Arbyn M, Lax SF, Raspollini MR, Nieminen P, Carcopino X, Bornstein J, Gultekin M, Paraskevaidis E. Terminology for cone dimensions after local conservative treatment for cervical intraepithelial neoplasia and early invasive cervical cancer: 2022 consensus recommendations from ESGO, EFC, IFCPC, and ESP. Lancet Oncol. 2022 Aug;23(8):e385-e392. doi: 10.1016/S1470-2045(22)00191-7. PMID 35901834
- BACKGROUNDFokom Domgue J, Schmeler KM. Conservative management of cervical cancer: Current status and obstetrical implications. Best Pract Res Clin Obstet Gynaecol. 2019 Feb;55:79-92. doi: 10.1016/j.bpobgyn.2018.06.009. Epub 2018 Jun 28. PMID 30029960
- RESULTCao DY, Yang JX, Wu XH, Chen YL, Li L, Liu KJ, Cui MH, Xie X, Wu YM, Kong BH, Zhu GH, Xiang Y, Lang JH, Shen K; China Gynecologic Oncology Group. Comparisons of vaginal and abdominal radical trachelectomy for early-stage cervical cancer: preliminary results of a multi-center research in China. Br J Cancer. 2013 Nov 26;109(11):2778-82. doi: 10.1038/bjc.2013.656. Epub 2013 Oct 29. PMID 24169350