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

NCT ID: NCT01679509

Last Updated: 2017-05-31

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

330 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-09-30

Study Completion Date

2017-07-31

Brief Summary

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

Detailed Description

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Conditions

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Benign Ovarian or Tubal Disease

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Single-port surgery group

Single-port laparoscopic adnexal surgery

Group Type EXPERIMENTAL

Single-port laparoscopic adnexal surgery

Intervention Type PROCEDURE

Three-port surgery group

Three-port laparoscopic adnexal surgery

Group Type ACTIVE_COMPARATOR

Three-port laparoscopic adnexal surgery

Intervention Type PROCEDURE

Interventions

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Single-port laparoscopic adnexal surgery

Intervention Type PROCEDURE

Three-port laparoscopic adnexal surgery

Intervention Type PROCEDURE

Eligibility Criteria

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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
Minimum Eligible Age

20 Years

Maximum Eligible Age

70 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Asan Medical Center

OTHER

Sponsor Role lead

Responsible Party

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Joo-Hyun Nam

Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Joo-Hyun Nam, M.D., Ph.D.

Role: PRINCIPAL_INVESTIGATOR

Asan Medical Center

Locations

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Department of Obstetrics and Gynecology, Universit of Ulsan College of Medicine, Asan Medical Center

Seoul, , South Korea

Site Status RECRUITING

Countries

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South Korea

Central Contacts

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Joo-Hyun Nam, M.D., Ph.D.

Role: CONTACT

82-2-3010-3633

Facility Contacts

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Joo-Hyun Nam, M.D., Ph.D.

Role: primary

82-2-3010-3633

Other Identifiers

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LESS-A

Identifier Type: -

Identifier Source: org_study_id

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