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

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

Status

Completed

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01064128

Enrollment

Registered

2010-02-08

Start date

2010-01-31

Completion date

2010-12-31

Last updated

2011-07-20

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

Conditions

Uterine Adenomyosis, Uterine Myoma

Keywords

Single-port, Laparoscopy, Hysterectomy, Pain, Cosmesis, Analgesics

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.

Interventions

PROCEDUREconventional laparoscopic hysterectomy

conventional 3 or 4 ports laparoscopic hysterectomy

PROCEDURESPA laparoscopic hysterectomy

single-port access laparoscopic hysterectomy

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

FEMALE

Age

30 Years to 60 Years

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame
Pain score measured by visual analog scale	postoperative 24 hours

Secondary

Measure	Time frame
Modified body image scale and cosmetic scar scale	postoperative 6 months

Countries

South Korea

Outcome results

None listed

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