Micro-laparoscopy and Single-port Hysterectomy
Condition: Pain, Postoperative
MeSH terms: Pain, Postoperative
Study type: Interventional

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.
    

Intervention name(s): micro-laparoscopy; Laparoendoscopic single site surgery
Intervention type(s): Procedure; Procedure
Intervention description(s): M-LPS hysterectomy was performed through one optical trans-umbilical 5 mm trocar and three 3 mm sovra-pubic ancillary ports. A 5 mm 0° endoscope and 3 mm laparoscopic instruments were utilized, choosing among graspers, cold scissors, suction/irrigation and bipolar coagulator.; LESS hysterectomy was performed through a multi-channel single trocar inserted in the umbilicus using an open technique (1.5-2 cm cutaneous incision), as previously reported. Intra-abdominal visualization was obtained with a 0° 5-mm telescope with a flexible tip. 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. 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.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: hysterectomy; single-port; micro-laparoscopy