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

NCT06759480 | Not Yet Recruiting

• 1 other identifier: GKLW-A-2024-111-01
• Study Type: observational
• Target: 500
• Locations: 0 countries
• Sites: N/A

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

Outcome Measures

Primary Outcomes (2)

• Overall survival

  The time from end of surgery to death from any cause.

  5 years

• Progression-free survival

  The time from end of surgery to either the first documented disease progression or death from any cause.

  5 years

Secondary Outcomes (2)

• Surgery complication rate

  Intraoperative or within 2 weeks after surgery

• Intraoperative blood loss

  Intraoperative blood loss

Study Arms (2)

LRH group

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

Procedure: Laparoscopic radical hysterectomy based on space anatomy

ARH group

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

Procedure: Abdominal radical hysterectomy

Interventions

Laparoscopic radical hysterectomy based on space anatomy 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.

LRH group

Abdominal radical hysterectomy PROCEDURE

This producre is a classic and traditional radical hysterectomy.

ARH group

Eligibility Criteria

• Age: 20 Years - 70 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients who clinically diagnosed with IB3 and IIA2 cervical cancer are retrospectively collected from electronic medical records of four tertiary medical center from January 2012 to January 2022

You may qualify if:

• Aged between 20 to 70 years
• Preoperative clinical diagnosis was FIGO 2018 stage IB3 or IIA2 cervical cancer;
• Patients who received standard Querleu-Morrow type C radical hysterectomy (including ARH or LRH based on space anatomy) and pelvic lymphadenectomy;
• no preoperative suspected lymph nodes metastasis, parametrial involvement or lower 1/3 vagina involvement.

You may not qualify if:

• patients who had active double cancer or uncontrolled serious concurrent disease that might compromise prognosis;
• pregnancy;
• incomplete radical surgery;
• follow-up time less than 6 months or lost to follow-up

Sponsors & Collaborators

• International Peace Maternity and Child Health Hospital: lead

Central Study Contacts

Sibang Chen

CONTACT

+86 18721757863; sibang_chen@163.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 28, 2024
• First Posted: January 6, 2025
• Study Start: December 27, 2024
• Primary Completion: January 15, 2025
• Study Completion: March 15, 2025
• Last Updated: January 6, 2025

Record last verified: 2024-12