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

Study Overview
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Brief Summary
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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.

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

Conditions
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Uterine Myoma, Uterine Adenomyosis

Intervention / Treatment
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* Procedure: conventional laparoscopic hysterectomy
* Procedure: SPA laparoscopic hysterectomy


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 30 Years
Maximum Age: 60 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: conventional laparoscopic hysterectomy<br>Three or four ports conventional laparoscopic hysterectomy | Procedure: conventional laparoscopic hysterectomy<br>* conventional 3 or 4 ports laparoscopic hysterectomy<br>|
| Active Comparator: SPA laparoscopic hysterectomy<br>Single umbilical incision laparoscopic hysterectomy | Procedure: SPA laparoscopic hysterectomy<br>* single-port access laparoscopic hysterectomy<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pain score measured by visual analog scale |  | postoperative 24 hours | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Modified body image scale and cosmetic scar scale |  | postoperative 6 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Single-port, Laparoscopy, Hysterectomy, Pain, Cosmesis, Analgesics