Uterine Fibroid, Uterine Leiomyosarcoma, Uterine Sarcoma
Conditions
Keywords
Uterine fibroids, TU-LESS, Multi-port laparoscopic surgery
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.
Interventions
PROCEDURETU-LESS
TU-LESS group will receive TU-LESS for myomectomy; MPLS group will receive MPLS for myomectomy
PROCEDUREMPLS
Patients with uterine who plan to receive MPLS for myomectomy
Sponsors
West China Second University Hospital
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Healthy volunteers
No
Inclusion criteria
* diagnosed with uterine fibroids before surgery on the basis of radiological or other examinations * will consider TU-LESS or MPLS for myomectomy
Exclusion criteria
* patients reluctant to long-term follow-up
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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 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. |
| 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. |
| 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. |
| 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. |
| 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. |
Other
| Measure | Time frame | Description |
|---|---|---|
| Objective evaluation of incision healing | From enrollment to 3 months after myomectomy. | The patients will be asked to give rating of the recovery of surgical incision from 1 (the most unsatisfied) to 10 (the most satisfied) through questionnaire and telephone follow up. |
Countries
China
Outcome results
None listed