Study of Laparoendoscopic Single Site Adnexal Surgery for Benign Ovarian and Tubal Disease

May 27, 2017 updated by: Joo-Hyun Nam, Asan Medical Center

Prospective Randomized Comparison of Single-port and Three-port Laparoscopic Adnexal Surgery

To compare the safety and efficacy between single-port and three-port adnexal surgery in patients with benign ovarian and tubal disease

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

330

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Korea, Republic of
      • Seoul, Korea, Republic of, 138-736
        • Recruiting
        • Department of Obstetrics and Gynecology, Universit of Ulsan College of Medicine, Asan Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years to 70 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

Inclusion Criteria:

  • Patient who undergo laparoscopic adnexal surgery due to following benign adenxal disease

    1. Benign teratoma
    2. Endometrioma
    3. Mucinous cystadenoma
    4. Serous cystadenoma
    5. Benign Brenner tumor
    6. Ectopic pregnancy(cornual, tubal, ovarian pregnancy, etc.)
    7. paratubal cyst, parovarian cyst
    8. Risk reducing bilateral salpingooophorecotmy due to familial breast/ovarian cancer syndrome
    9. Other benign adnexal disease requiring surgery
  • American Society of Anesthesiologist Physical Status classification I-II.
  • Patient who have signed written informed consent

Exclusion Criteria:

  • Uncontrolled medical disease
  • Active infectious disease
  • Previous pelvic radiation therapy
  • Patient who requires further procedure excluding adnexal surgery
  • Patient who has other pain source excluding adnexal disease
  • Pregnant and lactating woman

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Single-port surgery group
Single-port laparoscopic adnexal surgery
Procedure: Single-port laparoscopic adnexal surgery
Active Comparator: Three-port surgery group
Three-port laparoscopic adnexal surgery
Procedure: Three-port laparoscopic adnexal surgery

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
postoperative hospital stay
Time Frame: within 1 week after surgery
within 1 week after surgery

Secondary Outcome Measures

Outcome Measure
Time Frame
postoperative pain
Time Frame: within 1 week after surgery
within 1 week after surgery
postoperative analgesics requirement
Time Frame: within 1 week after surgery
within 1 week after surgery
quality of life
Time Frame: within 6 months aftr surgery
within 6 months aftr surgery
surgical stress response
Time Frame: within 2 days after surgery
within 2 days after surgery
operating time
Time Frame: immediately ater surgery
immediately ater surgery
transfusion requirement and amount
Time Frame: within 1 week after surgery
within 1 week after surgery
postoperative complication
Time Frame: within 1 months after surgery
within 1 months after surgery

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Asan Medical Center

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2012

Primary Completion (Anticipated)

July 1, 2017

Study Completion (Anticipated)

July 1, 2017

Study Registration Dates

First Submitted

September 3, 2012

First Submitted That Met QC Criteria

September 3, 2012

First Posted (Estimate)

September 6, 2012

Study Record Updates

Last Update Posted (Actual)

May 31, 2017

Last Update Submitted That Met QC Criteria

May 27, 2017

Last Verified

May 1, 2017

More Information

Terms related to this study

Other Study ID Numbers

  • LESS-A

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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