Ligasure Versus Diathermy Haemorrhoidectomy Under Local Anesthesia
Condition: Hemorrhoids
MeSH terms: Hemorrhoids; Hyperthermia
Study type: Interventional

Summary: 
      The objective of this prospective randomised trial was to compare the short- and long-term
      efficacy of conventional diathermy haemorrhoidectomy versus Ligasure™ diathermy, and to
      assess the short-term outcome of each procedure performed either under spinal anaesthesia or
      local anaesthesia with pudendal block with ropivacaine combined with intravenous sedation.

      We think, Ligasure haemorrhoidectomy under local anesthesia can be performed as day-case
      procedure and with equal results at long-term than conventional diathermy (considered goal
      standar of haemorrhoidectomy).
    

Detailed description: 
      Seventy-four consecutive patients with a long-standing history of symptomatic grade III or IV
      haemorrhoids were assigned randomly by means of a computer-generated list to conventional
      diathermy haemorrhoidectomy under spinal anaesthesia (group I); conventional diathermy
      haemorrhoidectomy with local anaesthesia combined with intravenous sedation (group II);
      Ligasure™ under spinal anaesthesia (group III) and Ligasure™ with local anaesthesia combined
      with intravenous sedation (group IV). Allocations were sealed in opaque numbered envelopes.
      All patients were operated on electively and by the same surgical team (two colorectal
      surgeons) and variables were collected after operation by an independent observer who was
      unaware of the operation performed.

      The intraoperative time was measured. Intraoperative and early (within the first 48 h)
      postoperative complications associated with the surgical procedure and complications related
      to the anaesthetic technique (headache, vomiting, nausea, acute urinary retention, bleeding
      and hypotension) were recorded. A 100-mm visual analogue scale (VAS) was used to assess the
      intensity of pain, which was measured at 2, 6 and 24 hours postoperatively and during the
      first bowel movement. Seven days after surgery, patients were contacted by phone and the
      following data were recorded: VAS score at rest and during bowel movements, bleeding
      (categorised as 0 = none, 1 = occasional with defecation, 2 = with each defecation, 3 = with
      and without defecation) and pruritus (categorised as 0 = none, 1 = occasional, 2 = frequent)
      and tenesmus (categorised as 0 = none, 1 = occasional, 2 = frequent). These variables were
      collected at 4 and 12 months after operation by an independent observer who was unaware of
      the operation performed. Clinical evaluation at 1 year included relapse, continence according
      to the incontinence score system of Jorge and Wexner19, anal stenosis, presence of skin tags,
      patient's degree of satisfaction (where 0 corresponded to a unsatisfactory result and 10 an
      excellent result) and days of sick leave.
    

Intervention name(s): diathermy haemorrhoidectomy under espinal anesthesia; diathermy haemorrhoidectomy under local anesthesia; Ligasure haemorrhoidetomy under spinal anestesia; Ligasure haemorrhoidectomy under local anesthesia
Intervention type(s): Procedure; Procedure; Procedure; Procedure
Intervention description(s): For surgery: conventional haemorrhoidectomy with diathermy (Milligan-Morgan).For anesthesia: lidocaine 2% at doses of 50-70 mg was used for spinal anaesthesia.; For surgery: conventional haemorrhoidectomy with diathermy (Milligan-Morgan). For anesthesia: pudendal nerve block, infiltration of the right and left pararectal spaces, anterior and presacral regions with ropivacaine (150 mg of ropivacaine [20 mL, 7.5 mg/mL] diluted in 50 mL of 0.9% physiological saline). Ten minutes before local anaesthesia, patients were sedated with i.v. remifentanil 0.05-0.15 μg·kg-1; For surgery: ligasure haemorrhoidectomy For anesthesia: lidocaine 2% at doses of 50-70 mg was used for spinal anaesthesia.; For surgery: haemorrhoidectomy with Ligasure For anesthesia: pudendal nerve block, infiltration of the right and left pararectal spaces, anterior and presacral regions with ropivacaine (150 mg of ropivacaine [20 mL, 7.5 mg/mL] diluted in 50 mL of 0.9% physiological saline). Ten minutes before local anaesthesia, patients were sedated with i.v. remifentanil 0.05-0.15 μg·kg-1
Other intervention name(s): diathermy excision haemorrhoids regional; open haemorrhoidectomy; regional anesthesia; diathermy excision haemorrhoids regional; open haemorrhoidectomy; perianal anesthetics infiltration; pudendal block; regional anesthesia; Ligasure for prolapsed piles; Ligasure for prolapsed piles; Pudendal block
Intervention MeSH terms: Anesthetics
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Treatment
Keywords: diathermy hemorrhoids; Ligasure; randomized controlled trial; Postoperative pain; Surgical Procedure, Ambulatory; Local Anesthesia; Safety procedure long term; Day Surgery