Status:
UNKNOWN
Laparoscopic Single-site Surgery Versus Conventional Entry in Ovarian Cystectomy
Lead Sponsor:
Ain Shams University
Conditions:
Ovarian Cyst Benign
Eligibility:
FEMALE
18-45 years
Phase:
NA
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...
Eligibility Criteria
Inclusion
- 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
- • 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.
Key Trial Info
Start Date :
May 1 2021
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
May 1 2023
Estimated Enrollment :
74 Patients enrolled
Trial Details
Trial ID
NCT04788498
Start Date
May 1 2021
End Date
May 1 2023
Last Update
March 9 2021
Active Locations (0)
Enter a location and click search to find clinical trials sorted by distance.
No Results Found
We couldn’t find results for the location/zipcode entered or within the selected range. Please check your input or adjust your search.