Ligasure Versus Diathermy Haemorrhoidectomy Under Local Anesthesia (LDHLA)

Hospital de Viladecans

Status: Completed

Conditions: Hemorrhoids

Treatments: Procedure: diathermy haemorrhoidectomy under local anesthesia; Procedure: Ligasure haemorrhoidetomy under spinal anestesia; Procedure: diathermy haemorrhoidectomy under espinal anesthesia; Procedure: Ligasure haemorrhoidectomy under local anesthesia

Study type: Interventional

Funder types: Other

Identifiers

NCT00617448

05/0008

Details and patient eligibility

About

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).

Full 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.

Enrollment: 81 patients

Sex: All

Ages: 20 to 90 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• patients with a long-standing history of symptomatic grade III or IV haemorrhoids

Exclusion criteria

• previous anal surgery, concomitant anal disease (fissure, fistula, incontinence and inflammatory bowel disease), use of anticoagulants or analgesics, known hypersensitivity to local anaesthetics and the inability to give written informed consent.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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81 participants in 4 patient groups

I

Active Comparator group

Description:

conventional diathermy haemorrhoidectomy under spinal anaesthesia

Treatment:

Procedure: diathermy haemorrhoidectomy under espinal anesthesia

II

Active Comparator group

Description:

conventional diathermy haemorrhoidectomy with local anaesthesia combined with intravenous sedation (group II)

Treatment:

Procedure: diathermy haemorrhoidectomy under local anesthesia

III

Active Comparator group

Description:

Ligasure haemorrhoidectomy under spinal anesthesia

Treatment:

Procedure: Ligasure haemorrhoidetomy under spinal anestesia

IV

Active Comparator group

Description:

Ligasure haemorrhoidectomy under local anesthesia

Treatment:

Procedure: Ligasure haemorrhoidectomy under local anesthesia