Back to resultsLaparoscopic Single-site Surgery Versus Conventional Entry in Ovarian Cystectomy
Primary Purpose
Ovarian Cyst Benign
Status
Unknown status
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Laparoendoscpoic single site surgery LESS
Conventional multiport laparoscopy
Sponsored by
About this trial
This is an interventional treatment trial for Ovarian Cyst Benign
Eligibility Criteria
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. 62. 2011:
- 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.
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Laparoendoscpoic single site surgery LESS
Conventional multiport laparoscopy
Arm Description
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
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.
Outcomes
Primary Outcome Measures
Postoperative pain
The pain will be assessed by a numeric rating scale of 0-10
Secondary Outcome Measures
Operative time
the time between the start of the incision up to the cutaneous closing of the trocar orifices
the need for conversion to laparotomy
the need for conversion to laparotomy
the need to add an additional trocar
the need to add an additional trocar
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04788498
Brief Title
Laparoscopic Single-site Surgery Versus Conventional Entry in Ovarian Cystectomy
Official Title
Laparoendoscopic Single-site Surgery Versus Conventional Multi-port Laparoscopy in Presumed Benign Ovarian Cystectomy: A Randomized Controlled Trial
Study Type
Interventional
2. Study Status
Record Verification Date
March 2021
Overall Recruitment Status
Unknown status
Study Start Date
May 1, 2021 (Anticipated)
Primary Completion Date
May 1, 2023 (Anticipated)
Study Completion Date
May 1, 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Ain Shams University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Ovarian Cyst Benign
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
74 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Laparoendoscpoic single site surgery LESS
Arm Type
Experimental
Arm Description
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
Arm Title
Conventional multiport laparoscopy
Arm Type
Active Comparator
Arm Description
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 Type
Procedure
Intervention Name(s)
Laparoendoscpoic single site surgery LESS
Intervention Description
• A SILS Port (Covidien®) with three access inlets will be inserted into the abdominal cavity using a Heaney clamp
Intervention Type
Procedure
Intervention Name(s)
Conventional multiport laparoscopy
Intervention Description
• It will be performed using a three-port system using a closed technique on the umbilicus, left and right lower quadrant area.
Primary Outcome Measure Information:
Title
Postoperative pain
Description
The pain will be assessed by a numeric rating scale of 0-10
Time Frame
at 24 hours ± 2 hour after the intervention
Secondary Outcome Measure Information:
Title
Operative time
Description
the time between the start of the incision up to the cutaneous closing of the trocar orifices
Time Frame
intraoperative
Title
the need for conversion to laparotomy
Description
the need for conversion to laparotomy
Time Frame
intraoperative
Title
the need to add an additional trocar
Description
the need to add an additional trocar
Time Frame
intraoperative
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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. 62. 2011:
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.
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Laparoscopic Single-site Surgery Versus Conventional Entry in Ovarian Cystectomy
We'll reach out to this number within 24 hrs