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A randomized controlled trial for comparing single hole laparoscopic versus porous laparoscopic hysterectomy in the treatment of cervical cancer

A randomized controlled trial for comparing single hole laparoscopic versus porous laparoscopic hysterectomy in the treatment of cervical cancer

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR1800017090
Enrollment
Unknown
Registered
2018-07-11
Start date
2018-08-01
Completion date
Unknown
Last updated
2018-07-16

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

diseases of obstetrics and gynecology

Interventions

Group 2:Porous laparoscopy

Sponsors

Southwest Hospital affiliated to the Army Military Medical University
Lead Sponsor

Eligibility

Sex/Gender
Female
Age
18 Years to No maximum

Inclusion criteria

Inclusion criteria: (1) Women older than 18 years old; (2) Histologically diagnosed primary cervical adenocarcinoma, squamous cell carcinoma, or adenosscale carcinoma. According to FIGO staging in IA1 (with lymphatic vascular infiltration), IA2, or IB1 stage. The ECOG general condition assessment standard at grade 0 to 1; (3) Long term follow-up for at least one year; (4) Agree to participate in the study and sign informed consent.

Exclusion criteria

Exclusion criteria: (1) The general condition is poor and cannot tolerate the peritoneoscope surgery since the serious internal medicine complication; (2) large lumps in the pelvic and abdominal cavity: the upper boundary of the lump exceeds the umbilicus level or the pregnancy uterus is more than 16 gestational weeks. The volume of the uterine myoma exceeds the pregnancy in April. The pelvic and abdominal cavity can be limited for operation space. The lump obstructs the visual field and the establishment of pneumoperitoneum or puncture may cause the swelling of the mass; (3) During the active period of reproductive system, urinary system or systemic infection. The operation can be postponed until the infection is cleared; (4) Coagulation disorders or those who are receiving therapeutic anticoagulant drugs; (5) Patients who had received chemotherapy or pelvic radiotherapy in the past; (6) Women with cervical cancer undergoing extensive hysterectomy; (7) BMI > 30; (8) Researchers believe that other medical or psychological diseases that may exist with the patients, which may not be able to cooperate with the researchers; (9) Tumor cells are neuroendocrine, clear cell or other serous cell types; (10) Progressive tumors larger than 4cm (IB2 - IV); (11) The uterus was more than 12cm; (12) The history of abdominal or pelvic Radiology; (13) Pregnancy; (14) Life expectancy is less than 6 months; (15) Metastases were found through imaging diagnosis, such as the aorta lymph nodes greater than 2cm and the CT guided biopsy found that the histological examination was positive for distant metastasis; (16) Surgical procedures are not acceptable due to serious diseases of other systems; (17) Unable to endure long lithotomy position and low head high position; (18) Lack of compliance or address away from medical institutions can not follow up with treatment. In addition, the patient agreed with lymph node localization during operation but it may be allergic to triphenyl methane or history of retroperitoneal surgery.

Design outcomes

Primary

MeasureTime frame
Intraoperative complications;

Secondary

MeasureTime frame
Postoperative complications;

Countries

China

Contacts

Public ContactWang Yanzhou

Southwest Hospital affiliated to the Army Military Medical University

w.y.z@foxmail.com+86 18680893816

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026