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

Tracking Information
First Received Date ^ICMJE	February 5, 2010
Last Updated Date	July 18, 2011
Start Date ^ICMJE	January 2010
Primary Completion Date	December 2010 (final data collection date for primary outcome measure)
Current Primary Outcome Measures ^ICMJE (submitted: February 5, 2010)	Pain score measured by visual analog scale [ Time Frame: postoperative 24 hours ] [ Designated as safety issue: No ]
Original Primary Outcome Measures ^ICMJE	Same as current
Change History	Complete list of historical versions of study NCT01064128 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures ^ICMJE (submitted: February 5, 2010)	Modified body image scale and cosmetic scar scale [ Time Frame: postoperative 6 months ] [ Designated as safety issue: No ]
Original Secondary Outcome Measures ^ICMJE	Same as current
Current Other Outcome Measures ^ICMJE	Not Provided
Original Other Outcome Measures ^ICMJE	Not Provided

Descriptive Information
Brief Title ^ICMJE	Study of Different Pain Scores in Single-Port Access (SPA) Laparoscopic Hysterectomy Versus Conventional Laparoscopic Hysterectomy
Official Title ^ICMJE	Randomized Controlled Study of Different Pain Scores in Single-Port Access (SPA) Laparoscopic Hysterectomy Versus Conventional Laparoscopic Hysterectomy
Brief 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.
Detailed Description	Not Provided
Study Type ^ICMJE	Interventional
Study Phase	Phase 3
Study Design ^ICMJE	Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment
Condition ^ICMJE	Uterine Myoma Uterine Adenomyosis
Intervention ^ICMJE	Procedure: conventional laparoscopic hysterectomy conventional 3 or 4 ports laparoscopic hysterectomy Procedure: SPA laparoscopic hysterectomy single-port access laparoscopic hysterectomy
Study Arm (s)	Active Comparator: conventional laparoscopic hysterectomy Three or four ports conventional laparoscopic hysterectomy Intervention: Procedure: conventional laparoscopic hysterectomy Active Comparator: SPA laparoscopic hysterectomy Single umbilical incision laparoscopic hysterectomy Intervention: Procedure: SPA laparoscopic hysterectomy
Publications *	Not Provided
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information
Recruitment Status ^ICMJE	Completed
Estimated Enrollment ^ICMJE	40
Completion Date	December 2010
Primary Completion Date	December 2010 (final data collection date for primary outcome measure)
Eligibility Criteria ^ICMJE	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
Gender	Female
Ages	30 Years to 60 Years
Accepts Healthy Volunteers	No
Contacts ^ICMJE	Contact information is only displayed when the study is recruiting subjects
Location Countries ^ICMJE	Korea, Republic of

Administrative Information
NCT Number ^ICMJE	NCT01064128
Other Study ID Numbers ^ICMJE	2009-09-093
Has Data Monitoring Committee	Yes
Responsible Party	Tae Joong, Kim/Clinical Assistant Professor, Samsung Medical Center
Study Sponsor ^ICMJE	Samsung Medical Center
Collaborators ^ICMJE	Not Provided
Investigators ^ICMJE	Not Provided
Information Provided By	Samsung Medical Center
Verification Date	July 2011
^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

To Top