Modified Tumor-free Techniques Operation to Cervical Cancer

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).

Conditions

• Cervical Cancer Stage IB2

Interventions

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.

Sponsors & Collaborators

• Hebei Medical University Fourth Hospital

  collaborator OTHER

• Second Hospital of Jilin University

  collaborator OTHER

• Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University

  collaborator OTHER

• Cangzhou Central Hospital

  collaborator OTHER

• Zhejiang Cancer Hospital

  collaborator OTHER

• Hunan Provincial Maternal and Child Health Care Hospital

  collaborator OTHER

• LanZhou University

  collaborator OTHER

• RenJi Hospital

  collaborator OTHER

• The Fourth Military Medical University, Xijing Hospital

  collaborator UNKNOWN

• Affiliated Hospital of Shanxi University of Traditional Chinese Medicine

  collaborator UNKNOWN

• Affiliated Hospital of North Sichuan Medical College

  collaborator OTHER

• Tianjin Central Hospital of Gynecology Obstetrics

  collaborator OTHER

• Southwest Hospital, China

  collaborator OTHER

• Obstetrics & Gynecology Hospital of Fudan University

  collaborator OTHER

• Union Hospital, Tongji Medical College, Huazhong University of Science and Technology

  collaborator OTHER

• Sichuan Cancer Hospital and Research Institute

  collaborator OTHER

• Peking Union Medical College Hospital

  lead OTHER

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

18 Years

Max Age

65 Years

Sex

FEMALE

Healthy Volunteers

No

Timeline & Regulatory

Start

2025-02-20

Primary Completion

2032-07-31

Completion

2032-07-31

Countries

• China

Study Locations