Recruitment

Recruitment Status
Completed

Inclusion Criterias

Age between 18 and 55 years
Number of myoma ≤2 and largest size ≤10cm
Women who were scheduled to have laparoscopic myomectomy
...
Age between 18 and 55 years
Number of myoma ≤2 and largest size ≤10cm
Women who were scheduled to have laparoscopic myomectomy
Appropriate medical status for laparoscopic surgery (American Society of Anesthesiologists Physical Status classification 1 or 2)
Image-confirmed uterine myoma

Exclusion Criterias

Women with pedunculated subserosal myoma or submucosal myoma
Women with any suggestion of malignant uterine or adnexal diseases
Women undergoing concomitant complex surgical procedures at the time of laparoscopic myomectomy such as severe adhesiolysis or resection for severe endometriosis
...
Women with pedunculated subserosal myoma or submucosal myoma
Women with any suggestion of malignant uterine or adnexal diseases
Women undergoing concomitant complex surgical procedures at the time of laparoscopic myomectomy such as severe adhesiolysis or resection for severe endometriosis
Women with diabetics, malignancy, or malnutrition, which can affect wound healing
Women having major medical comorbidity or psychiatric illness, which could affect follow-up and/or compliance
Women who refuse to participate or give consent to the procedures

Summary

Conditions
Uterine Myoma
Type
Interventional
Phase
Phase 3
Design
  • Allocation: Randomized
  • Intervention Model: Parallel Assignment
  • Masking: None (Open Label)
  • Primary Purpose: Treatment

Participation Requirements

Age
Between 18 years and 55 years
Gender
Only females

Description

The investigators plan to perform a multi-center randomized clinical trial on women scheduled for laparoscopic myomectomy. All women will get the same preoperative and postoperative care. Women will be assigned by chance to one of two groups: one group will receive single-port laparoscopic myomectom...

The investigators plan to perform a multi-center randomized clinical trial on women scheduled for laparoscopic myomectomy. All women will get the same preoperative and postoperative care. Women will be assigned by chance to one of two groups: one group will receive single-port laparoscopic myomectomy using V-Loc™ suture material (study group). The other group will receive conventional multi-port laparoscopic myomectomy using V-Loc™ suture material (control group). The investigators will collect information on suturing time and complications related to surgery.

Inclusion Criterias

Age between 18 and 55 years
Number of myoma ≤2 and largest size ≤10cm
Women who were scheduled to have laparoscopic myomectomy
...
Age between 18 and 55 years
Number of myoma ≤2 and largest size ≤10cm
Women who were scheduled to have laparoscopic myomectomy
Appropriate medical status for laparoscopic surgery (American Society of Anesthesiologists Physical Status classification 1 or 2)
Image-confirmed uterine myoma

Exclusion Criterias

Women with pedunculated subserosal myoma or submucosal myoma
Women with any suggestion of malignant uterine or adnexal diseases
Women undergoing concomitant complex surgical procedures at the time of laparoscopic myomectomy such as severe adhesiolysis or resection for severe endometriosis
...
Women with pedunculated subserosal myoma or submucosal myoma
Women with any suggestion of malignant uterine or adnexal diseases
Women undergoing concomitant complex surgical procedures at the time of laparoscopic myomectomy such as severe adhesiolysis or resection for severe endometriosis
Women with diabetics, malignancy, or malnutrition, which can affect wound healing
Women having major medical comorbidity or psychiatric illness, which could affect follow-up and/or compliance
Women who refuse to participate or give consent to the procedures

Locations

Seoul
Goyang
Seoul
Seoul
...
Seoul
Goyang
Seoul
Seoul

Tracking Information

NCT #
NCT01984632
Collaborators
Not Provided
Investigators
  • Principal Investigator: Taejong Song, MD CHA Gangnam Medical Center, CHA university, Seoul, Republic of Korea
  • Taejong Song, MD CHA Gangnam Medical Center, CHA university, Seoul, Republic of Korea