NCT06836869

Modified Tumor-free Techniques Operation to Cervical Cancer

A Multicenter, Non-inferiority Trial to Compare the Effectiveness and Safety of Laparoscopic Radical Hysterectomy Incorporating Modified Tumor-free Techniques Versus Abdominal Radical Hysterectomy in Patients With Stage IB2 Cervical Cancer

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 524 (estimated)
• Sponsor: Peking Union Medical College Hospital · Academic / Other
• Sex: Female
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

Summary

The goal of this clinical trial is to learn if laparoscopic radical hysterectomy incorporating modified tumor-free techniques (LRH-MTF) works to treat FIGO stage IB2 cervical cancer as good as abdominal radical hysterectomy (ARH). It will also learn about the safety of LRH-MTF. The main questions it aims to answer are: Does LRH-MTF achieve a non-inferior disease-free survival rate at 4.5 years post - operation compared to ARH? What complications do patients have during and after the operation when receiving LRH-MTF? Researchers will compare LRH-MTF to ARH to see if LRH-MTF works no worse than ARH in treating FIGO stage IB2 cervical cancer. Participants will: 1. Undergo either LRH-MTF or ARH as assigned by randomization. 2. Visit the hospital for follow-up according to the study schedule for various examinations including blood tests, imaging studies, and assessment of complications. 3. Complete quality-of-life questionnaires such as EORTC QLQ-C30, QLQ-CX24, FSFI, and FSDS-R at baseline (pre-operation) and specific time points during the follow - up period (post-operation 6 months, 1 year, 2 years, 3 years, 4.5 years).

Detailed description

A progress report will be conducted within 4 weeks after all participants have completed their 6-month postoperative visit (the 5th visit). The report will be performed by an independent third-party statistical team, which will provide a comprehensive analysis of the safety data, baseline characteristic, and perioperative indicators. The study will perform one final analysis.

Conditions

• Cervical Cancer Stage IB2

Interventions

Type	Name	Description
PROCEDURE	Laparoscopic radical hysterectomy incorporating modified tumor-free techniques	Thoroughly examine the pelvic and abdominal cavities. Coagulation of the fallopian tubes are recommanded at the beginning of the surgery. The use of uterine manipulator is prohibited. An "8"-suture at the uterine fundus is recommended. Insert a trocar 3 cm above the pubic symphysis and suspend the uterus by pulling with a needle holder. Alternative methods are also acceptable. Perform pelvic lymphadenectomy. Conduct radical hysterectomy according to the Q-M classification type C. Before incising the vagina, the upper part of the vagina must be closed (using a cable tie or suture), or the vagina can be incised transvaginally after deflating the pneumoperitoneum. Sterilized distilled water or saline solution (≥1000 mL) is used to irrigate the pelvic cavity. The vaginal stump can be sutured either laparoscopically or transvaginally.
PROCEDURE	Abdominal radical hysterectomy	At the onset of surgery, comprehensively explore the pelvic and abdominal cavities. If intraperitoneal metastases are identified, radical hysterectomy should be aborted. Perform pelvic lymphadenectomy. After lymph node resection, remove the lymph nodes from the surgical field promptly. Sentinel lymph node mapping and biopsy are not performed in this study. Perform radical hysterectomy according to type C of the Q-M classification. It can be accompanied by or without bilateral salpingo - oophorectomy. For patients who retain their ovaries, bilateral ovarian transposition can be carried out. Before incising the vagina, close the upper segment of the vagina and/or the vaginal stump. This can be achieved using instruments such as a large right - angle clamp or an auricular clamp. Sterilized distilled water or saline solution (≥1000 mL) is used to irrigate the pelvic cavity.

Timeline

• Start date: 2025-02-20
• Primary completion: 2032-07-01
• Completion: 2032-07-01
• First posted: 2025-02-20
• Last updated: 2026-03-27

Locations

17 sites across 1 country: China