None listed
Conditions
Brief summary
The objective of the present study was to assess if laparoscopic guided minilaparotomy could reduce the rupture rate of operative laparoscopy for the treatment of large non endometriotic ovarian cysts with no other risk factor for malignancy other than size
Interventions
The comparator is laparoscopic guided minilaparotomy.
Cyst will be removed by minilaparotomy after laparoscopic evaluation in the comparator group. A 3 to 7 cm transverse skin incision 1 to 2 cm below the pubic hair line and 2 to 4 cm above the pubic symphisis is carried out after diagnostic laparoscopy. Excision of the ovarian cyst is performed in the standard fashion and the ovarian edges approximated with a suture stitch avoiding the ovarian cortex.
Duration of the treatment is strictly li
The comparator is laparoscopic guided minilaparotomy. Cyst will be removed by minilaparotomy after laparoscopic evaluation in the comparator group. A 3 to 7 cm transverse skin incision 1 to 2 cm below the pubic hair line and 2 to 4 cm above the pubic symphisis is carried out after diagnostic laparoscopy. Excision of the ovarian cyst is performed in the standard fashion and the ovarian edges approximated with a suture stitch avoiding the ovarian cortex. Duration of the treatment is strictly limited to surgery. Follow up duration is limited to 1 month after discharge in order to verify short term complications and patient satisfaction.
Sponsors
Pierluigi Benedetti Panici, Italy.
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Open (masking not used)
Eligibility
Sex/Gender
All
Age
18 Years to 45 Years
Healthy volunteers
No
Inclusion criteria
Cyst largest diameter between 7 and 18 cm, no ultrasonographic suspect of endometriosis or malignancy (thick papillary projections, solid areas, central flow, and velocimetric features of high velocity and low resistance (9)), serum CA125 within normal range, Body Mass Index (BMI) below 29 kg/m2, American Society of Anesthesiologists’ physical status classification (ASA) class 0–2, no acute or chronic pelvic known disease, no sign of acute abdomen, no previous laparotomies, no requirement of other associated surgical procedures, possibility of placing an intrauterine manipulator and signed informed consent to the surgical procedure and to traditional surgical staging in case of unexpected malignancy.
Exclusion criteria
Endometriosis, patients with a contralateral cyst with greatest diameter larger than 7 cm.
Outcome results
None listed