An observational study in Cervical Cancer, sponsored by Peking Union Medical College Hospital. Completed. Open to female participants aged 18 Years to 45 Years. Per ClinicalTrials.gov, last updated 2024-07-05.
Sponsored by Peking Union Medical College Hospital · Observational
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.
This retrospective cohort study reported the reproductive intentions and outcomes of cervical cancer patients who underwent laparoscopic-assisted vaginal radical trachelectomy (LAVRT) .The LAVRT procedure began with laparoscopic pelvic lymphadenectomy, and all lymph nodes were removed for frozen pathological analysis. The laparoscopic-assisted vaginal radical trachelectomy procedure was continued only if the nodes were negative. The pararectal pouch was revealed, and the uterine arteries were divided from their origin to the internal iliac artery. The ureters were freed from the posterior leaf of the broad ligament down to the level where they entered the ureteral tunnel and then displaced laterally. The uterosacral ligaments, cardinal ligaments, and parametrial portions were then divided and dissected. The section of the procedure was performed laparoscopically. The vaginal epithelium was circumferentially incised approximately 3 cm distal to the endocervix. Frozen section analysis confirmed no cancer involvement at the endocervical or vaginal margin. The vaginal mucosa was sutured to the cervical stump to form a "new cervical os".
Postoperative adjuvant chemotherapy is indicated when women have at least one of 3 intermediate risk factors: stromal invasion of more than half of the cervix, lymphovascular space invasion (LVSI), or a tumor diameter of 4 cm or greater. Platinum-based chemotherapy (combination of paclitaxel and cisplatin or carboplatin for 3 courses) was used for these women.
Women attended follow-up visits every 3 months for the first 2 years, every 6 months for the next 3 years, and annually every year thereafter. At each follow-up visit, a physical and gynecological examination and a conventional Pap smear combined with an HPV test were performed. Abdominal (including both kidneys) and pelvic ultrasound (US) and serum tumor marker (SCC antigen or CA125 for adenocarcinoma) data were also included.
When tumor recurrence was suspected based on clinical findings or imaging studies, a positron emission tomography (PET)-CT scan was performed to investigate the extent of disease. Recurrence was confirmed by a lesion on biopsy or a positive PET-CT scan. The follow-up duration was measured from the day of the operation to the day of the last follow-up, death or loss to follow-up.
1,927 studies on the registry are indexed under Uterine Cervical Neoplasms; 576 are open to participants now.
This study's enrollment of 132 is below the median of 220 across 429 observational studies indexed under Uterine Cervical Neoplasms.
Browse Uterine Cervical Neoplasms studies →Peking Union Medical College Hospital is the lead sponsor of 1,148 studies on the registry; 474 are open to participants now.
Of its 5 completed or terminated interventional studies of FDA-regulated products, 0 (0%) have results posted.
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This study will include 132 patients with early-stage cervical cancer, who undergo laparoscopic-assisted vaginal radical trachelectomy.
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Exclusion Criteria:
The LAVRT procedure began with laparoscopic pelvic lymphadenectomy, and all lymph nodes were removed for frozen pathological analysis. The laparoscopic-assisted vaginal radical trachelectomy procedure was continued only if the nodes were negative. The pararectal pouch was revealed, and the uterine arteries were divided from their origin to the internal iliac artery. The ureters were freed from the posterior leaf of the broad ligament down to the level where they entered the ureteral tunnel and then displaced laterally. The uterosacral ligaments, cardinal ligaments, and parametrial portions were then divided and dissected. The section of the procedure was performed laparoscopically. The vaginal epithelium was circumferentially incised approximately 3 cm distal to the endocervix. Frozen section analysis confirmed no cancer involvement at the endocervical or vaginal margin. The vaginal mucosa was sutured to the cervical stump to form a "new cervical os".
Progression-Free Survival
the date of the treatment to the date of disease progression or death from any cause in the absence of progression
Time frame: 5-10 years
Pregnancy rate after surgery
Postoperative patients who have successfully conceived
Time frame: 5 years
Recurrence rate
The ratio of recurrent patients to the total enrolled patients
Time frame: 20years
Average operation time
The length of the surgery
Time frame: Intraoperative
bleeding volume
the amount of blood loss in the patient
Time frame: Intraoperative
No study locations are listed for this record.
Ran from Jan 2003 to primary completion in Jan 2013, 120 months.
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This study is completed, as verified in Jun 2024. You cannot join it, but the record below documents what was studied.
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