Study of Different Pain Scores in Single-Port Access (SPA) Laparoscopic Hysterectomy Versus Conventional Laparoscopic Hysterectomy

Uterine Myoma Clinical Trial

Official title:

Randomized Controlled Study of Different Pain Scores in Single-Port Access (SPA) Laparoscopic Hysterectomy Versus Conventional Laparoscopic Hysterectomy

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01064128
• Other study ID #: 2009-09-093
• Status: Completed
• Phase: Phase 3
• First received: February 5, 2010
• Last updated: July 18, 2011
• Start date: January 2010
• Est. completion date: December 2010

Study information

• Verified date: July 2011
• Source: Samsung Medical Center
• Contact: n/a
• Is FDA regulated: No
• Health authority: South Korea: Institutional Review Board
• Study type: Interventional

Clinical Trial Summary

Purpose:

The attempt to further reduce the operative trauma in laparoscopic hysterectomy led in new technique such as Single-Port Access (SPA) laparoscopic surgery. This new technique is considered as painless procedure and better cosmetic effect but there are not any publications to study a possible different pain score and cosmetic effect in new techniques versus conventional laparoscopic hysterectomy. In this randomized controlled study the researchers have investigated the pain scores and cosmetic satisfaction by modified body image scale and cosmetic scar scale.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: December 2010
• Est. primary completion date: December 2010
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 30 Years to 60 Years

Eligibility

Inclusion Criteria:

• Age 30-60, female

• Symptomatic (Dysmenorrhea, Palpable mass, Pelvic pain or discomfort, Urinary symptom, Increasing size, Menorrhagia) myomas or adenomyosis

• Suspected uterine myoma and/or adenomyosis on transvaginal ultrasonography (USG)

• At least a 6-month thorough follow-up record available

• Informed consent

Exclusion Criteria:

• Endometrial hyperplasia without myoma or adenomyosis

• Body Mass Index more than 30

• Huge uterus defined by longitudinal uterine diameter larger than 10cm and anteroposterior diameter larger than 8cm in USG

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Adenomyosis
• Leiomyoma
• Uterine Adenomyosis
• Uterine Myoma

Intervention

Procedure:
• conventional laparoscopic hysterectomy
conventional 3 or 4 ports laparoscopic hysterectomy
• SPA laparoscopic hysterectomy
single-port access laparoscopic hysterectomy

Locations

Country	Name	City	State
Korea, Republic of	Samsung Medical Center	Seoul

Sponsors (1)

Lead Sponsor	Collaborator
Samsung Medical Center

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Pain score measured by visual analog scale		postoperative 24 hours	No
Secondary	Modified body image scale and cosmetic scar scale		postoperative 6 months	No