Trial Information

Single Port Laparoscopy Versus Conventional Laparoscopy for Benign Adnexal Disease - A Randomized Controlled Trial.

Although there are many reports indicating that single port laparoscopy for benign adnexal
disease is feasible, there have to date not been published any randomized studies proving a
superior outcome compared to conventional laparoscopy.

Theoretically, there are several advantages with a single port access. Because only one
incision is made in place of several, less postoperative pain could be expected. The
incision made is slightly larger (2 cm) than the ones used in conventional laparoscopy. It
could therefore be easier to evacuate carbon dioxide gas (CO2) out of the abdomen after the
operation, resulting in less shoulder tip pain, which is a common discomfort
postoperatively. Carbon dioxide gas is considered to be responsible for postoperative
shoulder tip pain due to peritoneal stretching and diaphragmatic irritation (Alexander et
al. 1987, Sarli et al. 2000). The better cosmetic result due to only one incision is
apparent. If this improvement makes a different for the patients, is yet to be proven.

There might be fewer complications with single-port laparoscopy compared to conventional
laparoscopy. As mentioned above, serious complications like bowel and vessel injury, mostly
occurring when Verres needle or a trocar is introduced through the abdominal wall. By
reducing the number of trocars introduced, these complications might occur less commonly.

Performing a randomized controlled trial will bring more knowledge to whether single port
laparoscopy for benign adnexal disease will truly benefit the patients compared to the
established operating method for this condition.

Surgical technique:

Preoperatively, all patients will be given paracetamol 1.5 grams, diclofenac 100 mg and
oxycodone 10 mg as a single dose orally analgesics. Under general anaesthesia and
endotracheal intubation the patient will be positioned in the dorsal lithotomy position with
both legs supported in Allen stirrups and their arms resting alongside the body. An
orogastric tube will be placed to decompress the stomach and a Foley catheter will be placed
in the bladder.

In the single port laparoscopy group, 10 ml of 0.5 % bupivacaine hydrochloride (Marcain®)
will be injected subcutaneously as local anaesthetic before a 2 cm vertical incision
(measured with a sterile ruler) will be made through the umbilicus. The rectus fascia will
be sharply incised and a single multiport trocar (Laparo-Endoscopic Single-Site Surgery,
Olympus Winter & IBE GMBH, Hamburg, Germany) will be introduced via an introducer device in
the peritoneal cavity. This port has an insufflation channel that allows carbon dioxide
insufflation with the pressure set at 12 mm Hg. To obtain intrabdominal visualization, a
5-mm 30º telescope (EndoEye, Olympus Winter & IBE GMBH, Hamburg, Germany) will be used. A
diagnostic peritoneal lavage will be performed. The patient will be placed in a
Trendelenburg position. Curved hand instruments (HiQ LS, Olympus Winter & IBE GMBH, Hamburg,
Germany) will be used to provide efficient retraction to optimize surgical exposure. A
straight bipolar diathermy and scissors will be used to extirpate the cyst or remove the
adnexa. After cystectomy or adnexectomy has been performed, the excised tissue will be
removed through the multichannel port. Larger masses will be placed in 10-mm Endo Catch™
Gold (Covidien, Norwalk Connecticut, USA) to avoid spillage. If necessary, decompression of
pelvic masses will be done with a 14-gauge angiocath needle at the umbilical incision after
removal of the single port device. After removal of the tissue the multichannel access port
will be opened to evacuate CO2. The port will be removed and the fascia will be sutured with
Polysorb 0 suture. The skin will be closed using abrupt intracutaneous Polysorb 3-0 sutures.

In the conventional laparoscopy group, 5 ml of 0.5 % bupivacaine hydrochloride (Marcain®)
will be injected as local anaesthetic before a 1 cm incision will be made in the umbilicus.
Abdominal access will be gained by using an open entry technique. A suture will be placed in
the fascia with Polysorb 0. Carbon dioxide will be insufflated through this port with a
pressure set at 12 mm Hg. 5 ml of 0.5 % bupivacaine hydrochloride (Marcain®) will be
injected at each of the places for three additional ports. Two 5-mm accessory Versaport™
Blade less trocars (Covidien, Norwalk Connecticut, USA) will be inserted in the lower right
and left quadrant and a 12-mm Versaport™ Blade less trocar will be inserted in the midline,
approximately 2 cm above the symphysis. Diagnostic peritoneal lavage will be performed.
Cystectomy or adnexectomy will be performed using bipolar diathermy, scissors and a grasper.
The tissue will be placed in 10-mm Endo Catch™ Gold (Covidien, Norwalk Connecticut, USA) and
removed through the incision in the midline above the symphysis. If necessary, decompression
of pelvic masses will be done with a 14-gauge angiocath needle and the skin incision would
be extended to a maximum of 2 cm. The fascia in the midline incision above the symphysis
will be sutured with Polysorb 0 using the Endoclose® hook (Covidien, Norwalk Connecticut,
USA). The fascia in the umbilicus will be closed with the earlier placed suture and the
skin in the midline incisions will be closed using abrupt intracutaneous Polysorb 3-0
sutures. The incisions in the right en left fossa will be closed using Steristrips™.

After the operation, the patients will receive analgesics on request. Their pain scores will
be registered on a linear 10 cm visual analogue scale at 6 hours and 24 hours after the
operation. They will also be asked if they experience shoulder tip pain. This pain will be
registered after 6 hours and 24 hours. The use of analgesics while admitted at the hospital
will be registered. They will be discharged from the hospital the first postoperative day.
The patients will be contacted and asked about their use of analgesics for the next two
days.

Two months after the operation, the patients will be asked to rate their satisfaction with
the cosmetic result on a five point scale ranging from extremely unsatisfied to extremely
satisfied. There will also be taken a picture of the scar in the umbilicus, which will be
rated according to the Manchester scar scale (Beausang et al. 1998).