Comparison Between Laparoendoscopic Single-site Surgery and Multi-port Laparoscopy in Treating Uterine Fibroids
- Conditions
- Uterine FibroidUterine SarcomaUterine Leiomyosarcoma
- Interventions
- Procedure: TU-LESSProcedure: MPLS
- Registration Number
- NCT06244251
- Lead Sponsor
- West China Second University Hospital
- Brief Summary
Myomectomy was preferably applied in females with reproductive requirements, which could be achieved by transumbilical laparoendoscopic single-site surgery (TU-LESS) or multi-port laparoscopic surgery (MPLS). Power morcellation used in MPLS was correlated with unidentified risk of tumor dissemination, especially in cases with accidental surgical findings of uterine sarcoma or leiomyosarcoma. Moreover, TU-LESS was reported to exceed MPLS in fast recovery. Therefore, the aim of this prospective cohort study is to compare the effectiveness of fast recovery and relative risk of tumor dissemination between TU-LESS and MPLS in myomectomy for the treatment of uterine fibroids.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ACTIVE_NOT_RECRUITING
- Sex
- Female
- Target Recruitment
- 5000
- diagnosed with uterine fibroids before surgery on the basis of radiological or other examinations
- will consider TU-LESS or MPLS for myomectomy
- patients reluctant to long-term follow-up
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description TU-LESS for myomectomy TU-LESS Patients complaint of symptoms resulting from uterine fibroids, such as abnormal vaginal bleeding, frequent micturition, lower abdominal pain, constipation, etc or patients with uterine fibroids which were identified accidentally during routine body examination who consulted at our center for surgical removal of the fibroids. In the meantime, the diagnosis of uterine fibroids should be reconfirmed by at least one radiological examination at our center. The patients in the experiment group were those who received transumbilical laparoendoscopic single site surgery (TU-LESS) for myomectomy. MPLS for myomectomy MPLS Patients complaint of symptoms resulting from uterine fibroids, such as abnormal vaginal bleeding, frequent micturition, lower abdominal pain, constipation, etc or patients with uterine fibroids which were identified accidentally during routine body examination who consulted at our center for surgical removal of the fibroids. In the meantime, the diagnosis of uterine fibroids should be reconfirmed by at least one radiological examination at our center. The patients in the experiment group were those who received multiport laparoscopic surgery (MPLS) for myomectomy.
- Primary Outcome Measures
Name Time Method Duration of hospital stay after surgery From enrollment to 1 month after receiving myomectomy The number of days between myomectomy and the day of hospital discharge.
- Secondary Outcome Measures
Name Time Method Volume of bleeding during myomectomy From enrollment to 1 day after myomectomy. The exact volume of bleeding during myomectomy in both experimental and control group will be collected during surgery.
Occurrence of pelvic and abdominal metastasis after myomectomy in cases with accidental uterine malignancy From enrollment to 2 years after receiving myomectomy According to epidemiology data, a fraction of patients with primarily identified uterine fibroids will be pathologically diagnosed with uterine malignancy like uterine sarcoma after surgery. Whether the patients who were finally diagnosed with uterine malignancy based pathology developed abdominal or pelvic metastasis will be collected by telephone follow-up.
Time between myomectomy and exhaustion From enrollment to 1 week after myomectomy. The exact time between myomectomy and exhaustion will be collected during wards round by directly asking the patients.
Pregnancy outcome From enrollment to 2 years after myomectomy Whether the patient had pregnancy within 2 years after myomectomy. The information will be collected through online questionnaire and telephone.
VAS score at 4, 8, 12, 16, 20, 24 hours after myomectomy From enrollment to 24 hours after myomectomy The visual analogue score at 4, 8, 12, 16, 20, 24 hours after myomectomy will be collected through questionnaire.
Time of surgery From enrollment to 1 day after myomectomy. The time of surgery (from superficial incision to the end of umbilical suturing in experimental group and end of incision suturing in control group) will be collected during surgery.
Number of uterine fibroids resected during surgery. From enrollment to 1 day after myomectomy. The exact number of uterine fibroids resected during myomectomy in both experimental and control group will be collected during surgery.
Trial Locations
- Locations (1)
West China Second University Hospital
🇨🇳Chengdu, Sichuan, China