Study of Laparoscopic Radical Hysterectomy Based on Space Anatomy in Patients With IB3 and IIA2 Cervical Cancer

NCT ID: NCT06759480

Last Updated: 2025-01-06

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Total Enrollment: 500 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2024-12-27
• Study Completion Date: 2025-03-15

Brief Summary

Radical hysterectomy is an effect treatment for FIGO IB3 and IIA2 cervical cancer patients who refuse to receive radical concurrent chemoradiotherapy. However, due to the large tumor size, both patients and surgeons encountered the risk of substantial bleeding, urinary tract damage, and unsatisfactory resection during surgery. Therefore, the exploration of effective and safe surgical treatments is crucial in enhancing the quality of life and prognosis for patients. Laparoscopic radical hysterectomy (LRH) offers the advantages of reduced bleeding and accelerated recovery, thereby minimizing patient discomfort and enhancing their quality of life. However, the prognosis of patients who received LRH or traditional abdominal radical hysterectomy (ARH) remains controversial. We proposed a modified LRH skill based on new space anatomy concept. In our previous single-center study, the result demonstrates that LRH based on space anatomy leads to less intraoperative blood loss and decreased ureteral injury rate compared with traditional skill. The benefits of this new method for patient survival remain uncertain. In this multicenter retrospective study, we aim to assess clinical prognosis and safety of this new LRH compared with traditional abdominal radical hysterectomy (ARH) in FIGO IB3 and IIA2 cervical cancer.

Conditions

Locally Advanced Cervical Cancer

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: RETROSPECTIVE

Study Groups

LRH group

In this group, patients received a modified laparoscopic radical hysterectomy(LRH) based on space antomy.

Laparoscopic radical hysterectomy based on space anatomy

Intervention Type: PROCEDURE

This is a modified laparoscopic radical hysterectomy based on space anatomy. By identifying the vesicouterine ligament and four associated special spaces, the ureter can be completely liberated from the external aspect of the uterus. This skill not only reduces rate of surgical complications but also facilitates optimal tumor resection.

ARH group

In this group, patients received a traditional abdominal radical hysterectomy(ARH). ARH group is defined as a control group.

Abdominal radical hysterectomy

Intervention Type: PROCEDURE

This producre is a classic and traditional radical hysterectomy.

Interventions

Laparoscopic radical hysterectomy based on space anatomy

This is a modified laparoscopic radical hysterectomy based on space anatomy. By identifying the vesicouterine ligament and four associated special spaces, the ureter can be completely liberated from the external aspect of the uterus. This skill not only reduces rate of surgical complications but also facilitates optimal tumor resection.

Intervention Type: PROCEDURE

Abdominal radical hysterectomy

This producre is a classic and traditional radical hysterectomy.

Intervention Type: PROCEDURE

Eligibility Criteria

Inclusion Criteria

1. Aged between 20 to 70 years

2. Preoperative clinical diagnosis was FIGO 2018 stage IB3 or IIA2 cervical cancer;

3. Patients who received standard Querleu-Morrow type C radical hysterectomy (including ARH or LRH based on space anatomy) and pelvic lymphadenectomy;

4. no preoperative suspected lymph nodes metastasis, parametrial involvement or lower 1/3 vagina involvement.

Exclusion Criteria

1. patients who had active double cancer or uncontrolled serious concurrent disease that might compromise prognosis;

2. pregnancy;

3. incomplete radical surgery;

4. follow-up time less than 6 months or lost to follow-up

• Minimum Eligible Age: 20 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

International Peace Maternity and Child Health Hospital

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Central Contacts

Sibang Chen

Role: CONTACT

sibang_chen@163.com

+86 18721757863

Other Identifiers

GKLW-A-2024-111-01

Identifier Type: -

Identifier Source: org_study_id