Comparison Between Laparoendoscopic Single-site Surgery and Multi-port Laparoscopy in Treating Uterine Fibroids

NCT06244251 | Active Not Recruiting DMC

• 1 other identifier: 2023YFS0046
• Study Type: interventional
• Target: 5,000
• Locations: 1 country
• Sites: 1

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.

Conditions

Uterine Fibroid; Uterine Sarcoma; Uterine Leiomyosarcoma

Keywords

Uterine fibroids; TU-LESS; Multi-port laparoscopic surgery

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (7)

• VAS score at 4, 8, 12, 16, 20, 24 hours after myomectomy

  From enrollment to 24 hours after myomectomy

• Time between myomectomy and exhaustion

  From enrollment to 1 week after myomectomy.

• Time of surgery

  From enrollment to 1 day after myomectomy.

• Volume of bleeding during myomectomy

  From enrollment to 1 day after myomectomy.

• Number of uterine fibroids resected during surgery.

  From enrollment to 1 day after myomectomy.

Other Outcomes (1)

• Objective evaluation of incision healing

  From enrollment to 3 months after myomectomy.

Study Arms (2)

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.

Procedure: TU-LESS

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.

Procedure: MPLS

Interventions

TU-LESS PROCEDURE

TU-LESS group will receive TU-LESS for myomectomy; MPLS group will receive MPLS for myomectomy

TU-LESS for myomectomy

MPLS PROCEDURE

Patients with uterine who plan to receive MPLS for myomectomy

MPLS for myomectomy

Eligibility Criteria

• Gender Eligibility Details: Uterine fibroids occur only to female population
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• diagnosed with uterine fibroids before surgery on the basis of radiological or other examinations
• will consider TU-LESS or MPLS for myomectomy

You may not qualify if:

• patients reluctant to long-term follow-up

Sponsors & Collaborators

• West China Second University Hospital: lead

Study Sites (1)

West China Second University Hospital

Chengdu, Sichuan, 610041, China

Location

Related Publications (4)

• 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.

  PMID: 25051495 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.

  PMID: 36933684 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.

  PMID: 29078975 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.

  PMID: 37093509 RESULT

MeSH Terms

Conditions

Leiomyoma

Condition Hierarchy (Ancestors)

Neoplasms, Muscle Tissue; Neoplasms, Connective and Soft Tissue; Neoplasms by Histologic Type; Neoplasms

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Dean, Department of Obstetrics and Gynecology, West China Second University Hospital, Sichuan University

Study Record Dates

• First Submitted: August 9, 2023
• First Posted: February 6, 2024
• Study Start: June 24, 2023
• Primary Completion (Estimated): August 24, 2026
• Study Completion (Estimated): December 31, 2026
• Last Updated: February 6, 2024

Record last verified: 2024-01

Locations

CN (1)