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

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

Status

UNKNOWN

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01679509

Enrollment

330

Registered

2012-09-06

Start date

2012-09-30

Completion date

2017-07-31

Last updated

2017-05-31

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Benign Ovarian or Tubal Disease

Brief summary

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

Interventions

PROCEDURESingle-port laparoscopic adnexal surgery

PROCEDUREThree-port laparoscopic adnexal surgery

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

FEMALE

Age

20 Years to 70 Years

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame
postoperative hospital stay	within 1 week after surgery

Secondary

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

Countries

South Korea

Contacts

Primary ContactJoo-Hyun Nam, M.D., Ph.D.

jhnam@amc.seoul.kr82-2-3010-3633

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026