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Completed

NCT Number: NCT01064128

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

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.

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Key information

Conditions

Uterine Myoma Adenomyosis Connective Tissue Diseases Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Genital Diseases Genital Diseases, Female Myofibroma Neoplasms Neoplasms by Histologic Type Neoplasms, Connective Tissue Neoplasms, Connective and Soft Tissue Neurologic Manifestations Pain Pathological Conditions, Signs and Symptoms Signs and Symptoms Skin and Connective Tissue Diseases Urogenital Diseases Uterine Adenomyosis Uterine Diseases

Age range

30 year–60 year

Sex eligibility

Female

Study type

Interventional

Phase

Phase 3

Primary location

Samsung Medical Center

Seoul, 135-710, South Korea

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

conventional laparoscopic hysterectomy

Procedure

conventional 3 or 4 ports laparoscopic hysterectomy

SPA laparoscopic hysterectomy

Procedure

single-port access laparoscopic hysterectomy

Primary outcomes

  1. Pain score measured by visual analog scale

    Time frame: postoperative 24 hours

Secondary outcomes

  1. Modified body image scale and cosmetic scar scale

    Time frame: postoperative 6 months

Sponsors and collaborators

Lead sponsor

Samsung Medical Center

Other

Registry information

Official study title

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

Important dates

Study start
2010
Primary completion
2010
Study completion
2010
First posted
Feb 8, 2010
Registry last updated
Jul 20, 2011

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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