Laparoendoscopic Single-site Surgery Versus Conventional Multi-port Laparoscopy in Presumed Benign Ovarian Cystectomy: A Randomized Controlled Trial
Trial Snapshot
- Phase
- Not Applicable
- Sponsor
- Ain Shams University
- Enrollment
- 74
- Primary Endpoint
- Postoperative pain
Study Overview
Brief Summary
The aim of this work is to evaluate the postoperative consequences of laparoendoscopic single site surgery relative to conventional laparoscopy in presumed benign ovarian cyst.
The hypothesis is that single incision technique might offer advantages over the standard multi-port laparoscopy as potentially leading to less postoperative pain and improved cosmoses from a relatively hidden umbilical scar, as well as risk reduction of postoperative wound infection, hernia formation and elimination of multiple trocar site closure
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to 45 Years (Adult)
- Sex
- Female
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •The patients are aged 18 to 45 years with BMI < 35 kg/m2 and that they exhibit a surgical indication for a presumed benign ovarian pathology (PBOP) according to RCOG Guideline no.
- •simple ovarian cysts >7cm and <15cm.
- •Persistent simple cyst for more than 3 months.
- •Symptomatic patients with complicated cyst (e.g. hemorrhagic cyst, torsion, etc)
Exclusion Criteria
- •• Previous midline laparotomies as suspected massive adhesions affecting intraoperative maneuvers and time.
- •Chronic pelvic pain, endometriosis or pelvic inflammatory diseases will be excluded to avoid pelvic adhesions and bias in the quantification of postoperative pain.
- •Do not possess a native umbilicus giving difficult access to single port.
- •The 'risk of malignancy index' (RMI) should be used to exclude those women at greater risk of malignancy. Using an RMI cut-off of 200, a sensitivity of 70% and specificity of 90% can be achieved. if features suggestive of malignancy are encountered, a gynecological oncologist should be consulted regarding further evaluation and staging.
- •Benign teratomas for the difficulty of extraction after removal that affects the intraoperative maneuvers and time.
- •Contraindication to any laparoscopy like any medical condition worsened by pneumoperitoneum or the Trendelenburg position.
- •Contraindication to general anesthesia as all laparoscopic procedures are done under GA.
- •Contraindication to non-steroidal anti-inflammatories, paracetamol, or tramadol.
Arms & Interventions
Conventional multiport laparoscopy
35 patients undergoing laparoscopic ovarian cystectomy It will be performed using a three-port system using a closed technique on the umbilicus, left and right lower quadrant area.
Intervention: Conventional multiport laparoscopy (Procedure)
Laparoendoscpoic single site surgery LESS
35 patients undergoing laparoscopic ovarian cystectomy A SILS Port (Covidien®) with three access inlets will be inserted into the abdominal cavity using a Heaney clamp
Intervention: Laparoendoscpoic single site surgery LESS (Procedure)
Outcomes
Primary Outcomes
Postoperative pain
Time Frame: at 24 hours ± 2 hour after the intervention
The pain will be assessed by a numeric rating scale of 0-10
Secondary Outcomes
- the need for conversion to laparotomy(intraoperative)
- Operative time(intraoperative)
- the need to add an additional trocar(intraoperative)
Investigators
Mahmoud Nabil
Doctor
Ain Shams University