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

This study has been completed.
Sponsor:
Information provided by:
Samsung Medical Center
ClinicalTrials.gov Identifier:
NCT01064128
First received: February 5, 2010
Last updated: July 18, 2011
Last verified: July 2011
History of Changes
  Purpose

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.


Condition Intervention Phase
Uterine Myoma
Uterine Adenomyosis
 Procedure: conventional laparoscopic hysterectomy
Procedure: SPA laparoscopic hysterectomy
 Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Randomized Controlled Study of Different Pain Scores in Single-Port Access (SPA) Laparoscopic Hysterectomy Versus Conventional Laparoscopic Hysterectomy

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Samsung Medical Center:

Primary Outcome Measures:
  • Pain score measured by visual analog scale [ Time Frame: postoperative 24 hours ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Modified body image scale and cosmetic scar scale [ Time Frame: postoperative 6 months ] [ Designated as safety issue: No ]

Estimated Enrollment: 40
Study Start Date: January 2010
Study Completion Date: December 2010
Primary Completion Date: December 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: conventional laparoscopic hysterectomy
Three or four ports conventional laparoscopic hysterectomy
 Procedure: conventional laparoscopic hysterectomy
conventional 3 or 4 ports laparoscopic hysterectomy
Active Comparator: SPA laparoscopic hysterectomy
Single umbilical incision laparoscopic hysterectomy
 Procedure: SPA laparoscopic hysterectomy
single-port access laparoscopic hysterectomy

  Eligibility

Ages Eligible for Study:   30 Years to 60 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01064128

Locations
Korea, Republic of
Samsung Medical Center
Seoul, Korea, Republic of, 135-710
Sponsors and Collaborators
Samsung Medical Center
  More Information

No publications provided

Responsible Party: Tae Joong, Kim/Clinical Assistant Professor, Samsung Medical Center
ClinicalTrials.gov Identifier: NCT01064128     History of Changes
Other Study ID Numbers: 2009-09-093
Study First Received: February 5, 2010
Last Updated: July 18, 2011
Health Authority: South Korea: Institutional Review Board

Keywords provided by Samsung Medical Center:
Single-port
Laparoscopy
Hysterectomy
 Pain
Cosmesis
Analgesics

Additional relevant MeSH terms:
Myoma
Leiomyoma
Myofibroma
Endometriosis
Neoplasms, Muscle Tissue
Neoplasms, Connective and Soft Tissue
 Neoplasms by Histologic Type
Neoplasms
Neoplasms, Connective Tissue
Connective Tissue Diseases
Genital Diseases, Female

ClinicalTrials.gov processed this record on June 18, 2013