The participants will receive the assigned intervention, i.e. either SPL or CL. The surgical interventions will be undertaken or supervised by a surgeon who has expertise in the specific area of the intervention. There will be four participating surgeons who have appropriate training for the two techniques (AA, SP, CT, AP). Further details regarding the interventions are provided below.
Single-port endoscopic access
A single vertical subumbilical incision of 2 cm will be made, allowing for insertion of the monotrocar (Octoport®, Landanger, Chaumont, France). This monotrocar has an insufflation channel that allows insufflation of carbon dioxide at a pressure of 12 mmHg. An endoscope of 10 mm with an angulation of 0° will be used to visualize the abdominopelvic cavity.
Conventional laparoscopy instruments will be used for the procedure with bipolar forceps and monopolar scissors (Metzenbaum-type laparoscopic scissors, from Landanger and bipolar forceps with a wide bite such as Endopath® from Ethicon endo-surgery).
At the end of the surgical procedure a correct exsufflation will be performed after withdrawal of the monotrocar, and a suture of the abdominal aponeurosis will be made with polysorb 1. The cutaneous suture will be made with inverted intradermal stitches using monocryl 3.0.
Conventional laparoscopy
For the CL group, the abdominal cavity will be accessed by the open laparoscopy technique with a vertical subumbilical incision of 1 cm. A trocar of 10 mm will be placed in this orifice (Auto Suture Blunt Tip Trocar®, Covidien, USA). The carbon dioxide will be insufflated at a pressure of 12 mmHg. Two additional trocars of 5 mm will be added to the right and the left iliac fossa (Applied Medical®, CA, USA). The same 10-mm lens with an angulation of 0° and the same conventional instruments with bipolar forceps and monopolar scissors as for the SPL group will be used. Removal of the trocars will be done visually with correct exsufflation at the end of the procedure. The aponeurosis of the subumbilical orifice will be closed by a purse-string stitch with polysorb 1 and the cutaneous closure will be with separate inverted stitches using monocryl 3.0.
Aside from the laparoscopic approach, for which a single trocar will be used in the “SPL” arm, there is no difference compared to the usual treatment of patients.
The surgical techniques will be the same for the two groups. These comprise the intraperitoneal cystectomy laparoscopic surgery technique and the laparoscopic adnexal surgery technique [
26,
27].
The cystectomy will be performed by the divergent traction technique between cyst and ovarian wall after aspiration evacuation of the cyst. If necessary, hemostasis of the wall will be performed with bipolar energy. No suture will be performed on the ovarian at the end of the cystectomy. The adnexectomy will be performed by coagulation/sectioning of the infundibulopelvic ligament. The appendage will be connected to the uterine horn by sectioning the peritoneum of the anterior and posterior sides of the broad ligament. The connection of the uterine horn will then be able to be controlled by coagulation/sectioning of the utero-ovarian connection and of the Fallopian tube.
After a cystectomy or an adnexectomy, the surgical items are withdrawn with bag through the subumbilical orifice.
The patients in both groups will be under general anesthesia, placed in the Trendelenburg position, and a gynecological surgical site is prepared.
The perioperative and postoperative analgesia will be the same for all of the patients participating in the study. There will be no premedication for analgesic purposes.
The general anesthesia will comprise 0.2 mcg/kg of Sufentanil, 3 mg/kg of Propofol, a non-depolarizing neuromuscular blocking drug, and oro-tracheal intubation. The patients will undergo ventilation with a mixture of air/oxygen, Sevoflurane, Sufentanil (+5 mcg for pneumoperitoneum + 5 mcg before closing for procedures lasting > 1 h). The analgesia 1 h before waking up will comprise 1 g of paracetamol, 20 mg of nefopam, 1.25 mg of droleptan, 4 mg of dexamethasone, and 100 mg of profenid.
For both of the groups, the procedure will start with the cutaneous incision and it will end with the closing of the trocar orifices. There will be no local infiltration of the trocar orifices with analgesics as this procedure is not a standard of care in our department.
In case pain occurs in the first 2 h after the surgery, the patient will receive a 100 mg intravenous dose of tramadol (associated with a slow injection of 4 mg of intravenous ondansetron in case of nausea).
The patients will systematically receive two tablets containing 37.5 mg of tramadol/325 mg of paracetamol and a 100-mg tablet of ketoprofen at 6 h after the intervention per os. The analgesic treatment for the following days will comprise 37.5 mg of tramadol/325 mg of paracetamol: two tablets in the morning, at noon, and in the evening with one 100-mg tablet of ketoprofen in the morning and in the evening before meals (to which 20 mg of esomeprazole can be added if there is a prior history of ulcers that have healed or when taken along with aspirin). This treatment is taken systematically the day after the intervention and then if the pain continues. A per os rescue analgesia will be prescribed that is a combination of 25 mg opium/500 mg paracetamol in case of intense pain, to be renewed, if need be, every 4–6 h, without exceeding three capsules per day.