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Comparison of clinical efficacy between single-port laparoscopic surgery and double-port laparoscopic surgery for uterine fibroids: a prospective randomized controlled trial

Comparison of clinical efficacy between single-port laparoscopic surgery and double-port laparoscopic surgery for uterine fibroids: a prospective randomized controlled trial

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
ChiCTR
Registry ID
ChiCTR2600117021
Enrollment
Unknown
Registered
2026-01-19
Start date
2026-02-01
Completion date
Unknown
Last updated
2026-01-27

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

Conditions

Uterine fibroids

Interventions

Single-hole group:None
Double-hole group:None

Sponsors

Hubei Provincial Maternal and Child Health Hospital
Lead Sponsor

Eligibility

Sex/Gender
Female

Inclusion criteria

Inclusion criteria: 1. According to the diagnostic criteria for uterine fibroids in the "Chinese Expert Consensus on Diagnosis and Treatment of Uterine Fibroids", the fibroids were diagnosed as intramural fibroids through hysteroscopy, ultrasound, and magnetic resonance imaging before the operation. 2. There are surgical indications, and the patient intends to undergo laparoscopic removal of uterine fibroids while preserving the uterus. 3. The hemoglobin level is greater than 70g/l. 4. There are no abnormalities in the coagulation system, electrocardiogram, chest X-ray, etc. 5. The patient has not used GnRHa, HIFU or uterine artery embolization to reduce the volume of uterine fibroids within 3-6 months before the operation. 6. The patient has signed the informed consent form, agreeing to use their clinical data for this study, and is willing to cooperate with the subsequent follow-up surveys and other research work to ensure that the patient fully understands the research purpose, process, possible risks and benefits.

Exclusion criteria

Exclusion criteria: 1. Combined with severe functional disorders of important organs such as the heart, lungs, liver, and kidneys. 2. Pregnant or planning to become pregnant within 6 months. 3. Submucosal uterine fibroids. 4. Currently using anticoagulant drugs (such as warfarin, low molecular weight heparin) and not having discontinued them. 5. Active infections, abdominal or pelvic inflammation. 6. Comorbid with other malignant tumors or severe systemic diseases, such as malignant tumor metastasis, hematological malignancies, autoimmune diseases in an active stage, etc., which may affect surgical decisions and prognosis assessment, and will increase the complexity and uncertainty of the study.

Design outcomes

Primary

MeasureTime frame
Duration of the operation;Intraoperative blood loss;Postoperative wound cosmetic score;

Secondary

MeasureTime frame
Time of first exhaust;VAS score;Quality of life score at 3 months after operation;

Countries

China

Contacts

Public ContactTongfu Feng

Hubei Provincial Maternal and Child Health Hospital Affiliated to Tongji Medical College, Huazhong University of Science and Technology

ftfsunny@163.com+86 189 8612 3645

Outcome results

None listed

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