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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| TU-LESS for myomectomy | Experimental | 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 | Active Comparator | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| TU-LESS | Procedure | TU-LESS group will receive TU-LESS for myomectomy; MPLS group will receive MPLS for myomectomy |
|
| Measure | Description | Time Frame |
|---|---|---|
| Duration of hospital stay after surgery | The number of days between myomectomy and the day of hospital discharge. | From enrollment to 1 month after receiving myomectomy |
| Measure | Description | Time Frame |
|---|---|---|
| VAS score at 4, 8, 12, 16, 20, 24 hours after myomectomy | The visual analogue score at 4, 8, 12, 16, 20, 24 hours after myomectomy will be collected through questionnaire. | From enrollment to 24 hours after myomectomy |
| Time between myomectomy and exhaustion |
| Measure | Description | Time Frame |
|---|---|---|
| Objective evaluation of incision healing | 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. | From enrollment to 3 months after myomectomy. |
Inclusion Criteria:
Exclusion Criteria:
Uterine fibroids occur only to female population
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| West China Second University Hospital | Chengdu | Sichuan | 610041 | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 25051495 | Result | Wright JD, Tergas AI, Burke WM, Cui RR, Ananth CV, Chen L, Hershman DL. Uterine pathology in women undergoing minimally invasive hysterectomy using morcellation. JAMA. 2014 Sep 24;312(12):1253-5. doi: 10.1001/jama.2014.9005. No abstract available. | |
| 36933684 | Result | Yuan P, Shan L, Yang X, Yu F, Ge Z, Wang M, Tan H. The merging of dual umbilical port-incisions for contained morcellation in laparoscopic myomectomy. Am J Obstet Gynecol. 2023 Jul;229(1):72-74. doi: 10.1016/j.ajog.2023.03.018. Epub 2023 Mar 17. |
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We will share the study protocol after its publication
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| ID | Term |
|---|---|
| D007889 | Leiomyoma |
| ID | Term |
|---|---|
| D009379 | Neoplasms, Muscle Tissue |
| D018204 | Neoplasms, Connective and Soft Tissue |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
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| MPLS | Procedure | Patients with uterine who plan to receive MPLS for myomectomy |
|
The exact time between myomectomy and exhaustion will be collected during wards round by directly asking the patients. |
| From enrollment to 1 week after myomectomy. |
| Time of surgery | 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. | From enrollment to 1 day after myomectomy. |
| Volume of bleeding during myomectomy | The exact volume of bleeding during myomectomy in both experimental and control group will be collected during surgery. | From enrollment to 1 day after myomectomy. |
| Number of uterine fibroids resected during surgery. | The exact number of uterine fibroids resected during myomectomy in both experimental and control group will be collected during surgery. | From enrollment to 1 day after myomectomy. |
| Pregnancy outcome | Whether the patient had pregnancy within 2 years after myomectomy. The information will be collected through online questionnaire and telephone. | From enrollment to 2 years after myomectomy |
| Occurrence of pelvic and abdominal metastasis after myomectomy in cases with accidental uterine malignancy | 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. | From enrollment to 2 years after receiving myomectomy |
| 29078975 | Result | Glaser LM, Friedman J, Tsai S, Chaudhari A, Milad M. Laparoscopic myomectomy and morcellation: A review of techniques, outcomes, and practice guidelines. Best Pract Res Clin Obstet Gynaecol. 2018 Jan;46:99-112. doi: 10.1016/j.bpobgyn.2017.09.012. Epub 2017 Sep 29. |
| 37093509 | Result | Wang L, Deng JY, Li KP, Zhu PY. A systematic review and meta-analysis comparing robotic single-site versus multi-port myomectomy. J Robot Surg. 2023 Aug;17(4):1319-1328. doi: 10.1007/s11701-023-01597-9. Epub 2023 Apr 24. |