Clinical trial NCT01666483: Micro-laparoscopy and Single-port Hysterectomy
Official title: Micro-laparoscopic Versus Single-port Total Hysterectomy: a Randomized Trial.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Pain, Postoperative
Keywords: hysterectomy
single-port
micro-laparoscopy
Lead sponsor: Catholic University of the Sacred Heart
Sponsor class: OTHER
First posted: 2012-08-16
Enrollment: 71
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: A total of 86 patients underwent total hysterectomy. Three of them refused randomization, 34 were randomly assigned to undergo to laparoendoscopic single-site surgery (LESS) and 34 to undergo micro-laparoscopy (M-LPS).Laparoscopic hysterectomy can be safely performed by M-LPS and LESS.

Detailed description: Between May 2011 and February 2012 a prospective randomized study was carried out at the Department of Obstetrics and Gynecology, Division of Gynecologic Oncology, Catholic University of the Sacred Heart, Rome-Italy.

Consenting patients scheduled to be submitted to a total laparoscopic hysterectomy for benign, pre-malignant and malignant disease were evaluated for this study. Inclusion criteria for total laparoscopic hysterectomy were: appropriate medical status for laparoscopic surgery; uterine size \< 12 weeks of pregnancy; no previous longitudinal major abdominal surgery. Patients who had a pelvic organ prolapse greater than grade I, were excluded from this study.

Pre-operative work-up included gynecologic examination, trans-vaginal ultrasound. In case of early endometrial and cervical cancer a staging MRI or CT was performed.

Our institutional review board approved the study (Protocol number P/473/CE/2011), and all women gave their informed consent to use their data. All patients were adequately informed concerning the possible risks and benefits of the described technique and signed a written consent agreeing to undergo the procedure and to eventual conversion to LPS or laparotomy, if necessary.

Patients were randomly assigned to either a hysterectomy with LESS or with M-LPS. The surgeon was notified of the allocation in theater on the morning of the procedure. The same surgical team performed both techniques. Assignment to one of the two surgical approaches was on 1:1, using a block randomized computer-generated list.

The operative time (OT) was defined as the interval between start incisions to closure. The intra-operative complications was defined as bowel, bladder, ureteral, or vascular injuries, and the estimated blood loss (EBL) ≥ 500 ml. Anemia was considered when hemoglobin level was ≤ 8 g/dl and fever when body temperature was at least 38C° in two consecutive measurements at least 6 hours apart, excluding the first day after surgery.

Post-operative pain assessment (in the immediate post-operative period) was performed in all patients using a validated Visual Analog Pain Scale (VAS) and scored from 0 to 10 (0 = no pain and 10 = agonizing pain). Post-operative pain was subjectively reported considering the patient at rest at 20 minutes and 2-4-8 hours after surgery. All patients were managed with the same intra-operative anesthetic protocol and post-operative analgesic drug (Paracetamol 1,000 mg) was administered only on patient's demand.

LPS conversion was defined as single or multiple 5 mm port insertion. The perioperative complications were defined as those occurring within the first month following the procedure.

Surgical Technique The operative technique is the same in the two groups with the exception of videoloparoscope, port type and some specific instruments. Once achieved pneumoperitoneum (12 mmHg), a careful inspection of the entire abdominal cavity was performed as first surgical step. All surgical procedures were performed with an intrauterine manipulator. After coagulation and section of round ligament to enter into the retroperitoneal space, the ureter was visualized and a haemostatic clip was positioned at the origin of the uterine artery. In order to safely cauterize and dissect the ovarian vessels, a window was opened between the left ovarian pedicle above and the ureter below. The vesico-uterine and vesico-vaginal peritoneum was dissected starting from the lateral to the medial. These surgical steps allow an excellent skeletonization of the uterine vessels, medially to the ureter along the uterus, which can be easily cauterizated and sectioned. The vagina was incised circumferentially following the porcelain-valve of the uterine manipulator as a guide. The uterus and the adnexa were extracted through the vagina. The vaginal vault was closed with a running suture. A hydro-pneumatic test for bladder integrity at the end of surgery was always performed.

LESS hysterectomy was performed through a multi-channel single trocar (TriPort, Olympus Winter \& Ibe GmbH, Hamburg - Germany) inserted in the umbilicus using an open technique (1.5-2 cm cutaneous incision), as previously reported (7). Intra-abdominal visualization was obtained with a 0° 5-mm telescope with a flexible tip (EndoEYE, Olympus Winter \& Ibe GmbH, Hamburg - Germany). Working straight 5-mm instruments were inserted into the remaining 2 ports, choosing among graspers, cold scissors, suction/irrigation bipolar coagulator and a multifunctional versatile laparoscopic device, which grasps, coagulates and transects simultaneously (PKS cutting forceps, 43 cm, Gyrus ACMI, Hamburg, Germany). In order to prevent clashing between instruments and surgeon's hands and to facilitate surgical manoeuvres, the combination of one 33 cm-long instrument with a 43 cm-long instrument was adopted. The umbilical fascia was closed with a figure-of-eight 0-Vicryl.

M-LPS hysterectomy was performed through one optical trans-umbilical 5 mm trocar (Endopath Xcel 5mm optiview, Ethicon Endo-Surgery, Cincinnati, OH) and three 3 mm sovra-pubic ancillary ports (Karl Storz Endoskope - 3 mm trocar set, Karl Storz, Tuttlingen, Germany). A 5 mm 0° endoscope (EndoEYE, Olympus Winter \& Ibe GmbH, Hamburg - Germany) and 3 mm laparoscopic instruments (Karl Storz Endoskope - 3 mm Instrument Set, Karl Storz, Tuttlingen, Germany) were utilized, choosing among graspers, cold scissors, suction/irrigation and bipolar coagulator (PK 3mm, Gyrus ACMI, Hamburg - Germany). The present study is the first randomised one that directly compared M-LPS and LESS for total hysterectomy. We can argue that comparing two minimally invasive surgeries, variations are minimal and only a careful analysis can identify them. In our trial, we showed that there were no significant differences between the two techniques in terms of peri-operative outcomes except for OT that was longer in LESS with respect to M-LPS.As far as early post-operative pain is concerned, we found that patients undergoing M-LPS experienced significantly less pain with respect to those managed by LESS.

Eligibility criteria: Inclusion Criteria:

* appropriate medical status for laparoscopic surgery;
* uterine size \< 12 weeks of pregnancy;
* no previous longitudinal major abdominal surgery.

Exclusion Criteria:

* pelvic organ prolapse greater than grade I

Primary outcomes:
measure: Post-operative pain
timeFrame: within 8 hours after surgery
Secondary outcomes:
Other outcomes:
Locations:
city: Rome
country: Italy
facility: Francesco Fanfani
Study officials:
affiliation: Catholic University of the Sacred Heart
name: Francesco Fanfani, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Catholic University of the Sacred Heart
name: Anna Fagotti, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Catholic University of the Sacred Heart
name: Maria L Gagliardi, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Catholic University of the Sacred Heart
name: Giorgia Monterossi, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Catholic University of the Sacred Heart
name: Cristiano Rossitto, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Catholic University of the Sacred Heart
name: Barbara Costantini, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Catholic University of the Sacred Heart
name: Salvatore Gueli Alletti, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Catholic University of the Sacred Heart
name: Giovanni Scambia, MD
role: PRINCIPAL_INVESTIGATOR
References: