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Modified Tumor-free Techniques Operation to Cervical Cancer
Sponsor: Peking Union Medical College Hospital
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).
Official title: 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
Key Details
Gender
FEMALE
Age Range
18 Years - 65 Years
Study Type
INTERVENTIONAL
Enrollment
524
Start Date
2025-02-20
Completion Date
2032-07
Last Updated
2026-03-27
Healthy Volunteers
No
Conditions
Interventions
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.
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.
Locations (17)
The First Hospital of Lanzhou University
Lanzhou, Gansu, China
Sun Yat-sen Memorial Hospital, Sun Yat-sen University
Guangzhou, Guangdong, China
Cangzhou Central Hospital
Cangzhou, Hebei, China
The Fourth Hospital of Hebei Medical University
Shijiazhuang, Hebei, China
Hunan Provincial Maternal and Child Health Care Hospital
Changsha, Hunan, China
The Second Hospital of Jilin University
Changchun, Jilin, China
Renji Hospital Affiliated to The Shanghai Jiao Tong University Medical School
Shanghai, Shanghai Municipality, China
Affiliated Hospital of Shanxi University of Traditional Chinese Medicine
Xianyang, Shanxi, China
The Fourth Military Medical University, Xijing Hospital
Xi’an, Shanxi, China
Affiliated Hospital of North Sichuan Medical College
Nanchong, Sichuan, China
Zhejiang cancer hospital
Hangzhou, Zhejiang, China
Peking Union Medical College Hospital
Beijing, China
Sichuan Cancer Hospital and Institute
Chengdu, China
Southwest Hospital
Chongqing, China
Obstetrics & Gynecology Hospital of Fudan University
Shanghai, China
Tianjin Central Hospital of Gynecology Obstetrics
Tianjin, China
Tongji Medical College
Wuhan, China