Hemorrhoids Clinical Trial
Official title:
Ligasure™ Versus Diathermy Haemorrhoidectomy Under Spinal or Local Anaesthesia With Ropivacaine. A Randomized Study With One Year Follow-up
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).
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.
;
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Outcomes Assessor), Primary Purpose: Treatment
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