Clinical Value of the Fertility-preserving Surgery in Cervical Cancer

Trial Title: Clinical Value of the Fertility-preserving Surgery in Cervical Cancer

NCT ID: NCT05806125

Condition: Cervical Cancer

Conditions: Official terms:
Uterine Cervical Neoplasms

Conditions: Keywords:
computed tomography angiography
diameter of the supplying artery
fertility outcome
uterine blood supply pattern

Study type: Observational

Overall status: Recruiting

Study design:

Time perspective: Retrospective

Summary: Purpose: To evaluate the clinical value of preserving the ascending branch of the uterine artery in improving the uterine blood supply after radical trachelectomy (RT). Method: This study will include 100 patients with early-stage cervical cancer, who undergo RT with the preservation of the ascending branch of the uterine artery. A new skill called the "cuff-sleeve" suture method is introduced to wrap the vagina around the stump cervix, wherein they are sutured using a 2-0 absorbable suture by placing two cross-stitches in the anterior and posterior wall, respectively, without piercing the cervical mucosa layer or damaging the uterine arteries. Study groups: The patients will be categorized into two groups. Patients in the postoperative group will undergo computed tomography angiography (CTA) after surgery and patients in the preoperative group will undergo CTA before RT. Data collection: Data regarding individual patient characteristics, International Federation of Gynecology and Obstetrics (FIGO) stage, histologic subtype, lymphovascular space involvement (LVSI) status, recurrence, CTA data, fertility results, and obstetric outcomes will be collected for the patients in the postoperative group. The CTA findings of the preoperative group will be obtained. 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.

Detailed description: Purpose: To evaluate the clinical value of preserving the ascending branch of the uterine artery in improving the uterine blood supply after radical trachelectomy (RT). Method: This study will include 100 patients with early-stage cervical cancer, who undergo RT with the preservation of the ascending branch of the uterine artery, at Sun Yat-sen Memorial Hospital, Sun Yat-sen University. The investigators attribute the uterine artery occlusion to the inevitable injury of the remaining uterine arteries during the ligation of the descending branch of the uterine artery and continuous or intermittent suturing. Hence, the investigators will carefully skeletonize the three branches of the uterine artery, ligates the vaginal and cervical branches, and preserves the ascending branch of the uterine artery under direct vision. Furthermore, a new skill called the "cuff-sleeve" suture method is introduced to wrap the vagina around the stump cervix, wherein they are sutured using a 2-0 absorbable suture by placing two cross-stitches in the anterior and posterior wall, respectively, without piercing the cervical mucosa layer or damaging the uterine arteries. Study groups: The patients will be categorized into two groups. All patients in the postoperative group will undergo computed tomography angiography (CTA) to evaluate the status of the preserved ascending branch and the residual uterine blood supply pattern after surgery. Patients in the preoperative group will undergo CTA before RT to determine the uterine blood supply pattern in healthy individuals. Data collection: Data regarding individual patient characteristics, International Federation of Gynecology and Obstetrics (FIGO) stage, histologic subtype, lymphovascular space involvement (LVSI) status, recurrence, CTA data, fertility results, and obstetric outcomes will be collected for the patients in the postoperative group. The CTA findings of the preoperative group will be obtained. The CTA data are mainly analyzed to determine the arteries supplying the uterus. The investigators consider a vessel as a supplying artery only when it is continuous from its origin up to the entry into the uterus and then branches. The uterine blood supply in patients is divided into three patterns based on the supplying vessels. The first is the ovarian artery-supplying pattern, wherein the residual uterus is supplied only by the ovarian arteries. The second is the hybrid-supplying pattern, in which an ovarian artery or a newly formed artery supplied the residual uterus along with the contralateral uterine artery. The third is the uterine artery-supplying pattern, wherein the residual uterus is supplied only by the uterine arteries. Furthermore, the diameter of the visualized supplying vessels is recorded. The diameters of the uterine and newly formed arteries are measured 2 cm before they enter the corpus uteri. However, the ovarian artery diameter is measured at its origin from the aorta ventralis, beside the external iliac artery, and 2 cm before it enters the corpus uteri since the ovarian arteries are convoluted. 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.

Criteria for eligibility:

Study pop:
This study will include 100 patients with early-stage cervical cancer, who undergo RT with the preservation of the ascending branch of the uterine artery. A new skill called the "cuff-sleeve" suture method is introduced to wrap the vagina around the stump cervix, wherein they are sutured using a 2-0 absorbable suture by placing two cross-stitches in the anterior and posterior wall, respectively, without piercing the cervical mucosa layer or damaging the uterine arteries.

Sampling method: Non-Probability Sample
Criteria:
Inclusion Criteria: - 1. Female, ≥20 years old; 2. Clinical diagnosis of cervical cancer; 3. Received radical trachelectomy; 4. Have good compliance, and can complete the enrollment by the requirements of the trial; 5. Sign informed consent and agree to the collection and use of their data. Exclusion Criteria: - 1. Have received other anti-tumor treatments or received tumor surgery before enrollment; 2. With other malignant tumors; 3. With uncontrollable neurological, psychiatric, or mental disorders.

Gender: Female

Minimum age: 20 Years

Maximum age: 45 Years

Healthy volunteers: No

Locations:

Facility:
Name: The Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University

Address:
City: Guangzhou
Zip: 510000
Country: China

Status: Recruiting

Contact:
Last name: Huaiwu Lu

Phone: +8618688395806
Email: luhuaiwu@mail.sysu.edu.cn

Start date: January 1, 2023

Completion date: December 1, 2024

Lead sponsor:
Agency: Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
Agency class: Other

Source: Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University

Record processing date: ClinicalTrials.gov processed this data on November 12, 2024

Source: ClinicalTrials.gov page: https://clinicaltrials.gov/ct2/show/NCT05806125