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Laparoscopic Myomectomy Using Barbed or Conventional Sutures

Cairo University (CU) logo

Cairo University (CU)

Status and phase

Completed
Phase 2

Conditions

Fibroid

Treatments

Procedure: myomectomy using barbed sutures
Procedure: myomectomy using conventional sutures

Study type

Interventional

Funder types

Other

Identifiers

NCT02166411
lap.myomectomy

Details and patient eligibility

About

The aim of this study is to compare operative data and early postoperative outcomes of laparoscopic myomectomy using barbed sutures with those of laparoscopic myomectomy using conventional sutures .

Full description

• Till now , there is only one small randomized controllrd study (n=22 in each arm) which compared the use of barbed suture with conventional suture in laparoscopic myomectomy .The myoma bed was closed with either conventional polyglactin suture or unidirectional barbed suture . The operative time was shorter in the barbed suture group (73.3 ± 21.4 min Vs. 80.7 ± 18.6 min) but this difference failed to reach statistical significance because of small sample size . However, the time required to suture the myoma beds was significantly lower in the barbed suture group .

Enrollment

92 patients

Sex

Female

Ages

18 to 55 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

  • the presence of one to three symptomatic intramural or subserosal myomas (with largest fibroid diameter less than 10 cm).

Exclusion criteria

  • submucosal myoma
  • calcified myomas
  • uterine size more than 16 weeks
  • suspension of genital malignancy
  • coagulation defects or concurrent anticoagulant therapy
  • pregnancy
  • compromised cardiopulmonary status
  • previous treatment with gonadotropin-releasing hormone analogue
  • contraindications for general anesthesia.

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

92 participants in 2 patient groups

myomectomy using barbed sutures
Experimental group
Description:
.Myoma bed is sutured with barbed sutures
Treatment:
Procedure: myomectomy using barbed sutures
myomectomy using conventional sutures
Active Comparator group
Description:
Myoma bed is sutured with conventional sutures
Treatment:
Procedure: myomectomy using conventional sutures

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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