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

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Samsung Medical Center

Status and phase

Completed
Phase 3

Conditions

Uterine Myoma
Uterine Adenomyosis

Treatments

Procedure: SPA laparoscopic hysterectomy
Procedure: conventional laparoscopic hysterectomy

Study type

Interventional

Funder types

Other

Identifiers

NCT01064128
2009-09-093

Details and patient eligibility

About

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.

Enrollment

40 estimated patients

Sex

Female

Ages

30 to 60 years old

Volunteers

No 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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

40 participants in 2 patient groups

conventional laparoscopic hysterectomy
Active Comparator group
Description:
Three or four ports conventional laparoscopic hysterectomy
Treatment:
Procedure: conventional laparoscopic hysterectomy
SPA laparoscopic hysterectomy
Active Comparator group
Description:
Single umbilical incision laparoscopic hysterectomy
Treatment:
Procedure: SPA laparoscopic hysterectomy

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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