Single Incision Laparoscopic Surgery (SILS) Versus Conventional Laparoscopic Hysterectomy

Samsung Medical Center

Status and phase: Unknown; Phase 3

Conditions: Uterine Myoma; Uterine Adenomyosis

Treatments: Procedure: Conventional laparoscopic hysterectomy; Procedure: Single incision Laparoscopic hysterectomy

Study type: Interventional

Funder types: Other

Identifiers

NCT01483417

2011-10-004

Details and patient eligibility

About

Multi-center prospective randomized trial of single port laparoscopic surgery (SILS) versus conventional 3-4 ports laparoscopic hysterectomy. Hypothesis is that conversion rate of SILS is not inferior to that of conventional approach.

Enrollment: 240 estimated patients

Sex: Female

Ages: 20 to 60 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Symptomatic (dysmenorrhea, palpable mass, pelvic pain or discomfort urinary symptom, increasing size, menorrhagia) myomas or adenomyomas
• Uterine size < gestational age of 14 weeks
• Informed consent

Exclusion criteria

• Medical diseases such as heart failure, renal insufficiency, liver cirrhosis, pancreatitis, uncontrolled DM
• Huge uterine size > gestational age of 14 weeks

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

---

240 participants in 2 patient groups

SILS

Experimental group

Description:

Laparoscopic hysterectomy including LAVH, LH(a), and TLH using SILS port

Treatment:

Procedure: Single incision Laparoscopic hysterectomy

Conventional multi-port laparoscopic hysterectomy

Active Comparator group

Description:

3-4 ports laparoscopic hysterectomy including LAVH, LH(a), or TLH

Treatment:

Procedure: Conventional laparoscopic hysterectomy