Ligasure Versus Diathermy Haemorrhoidectomy Under Local Anesthesia

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).

Conditions

• Hemorrhoids

Interventions

PROCEDURE

diathermy haemorrhoidectomy under espinal anesthesia

For surgery: conventional haemorrhoidectomy with diathermy (Milligan-Morgan).For anesthesia: lidocaine 2% at doses of 50-70 mg was used for spinal anaesthesia.

PROCEDURE

diathermy haemorrhoidectomy under local anesthesia

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

PROCEDURE

Ligasure haemorrhoidetomy under spinal anestesia

For surgery: ligasure haemorrhoidectomy For anesthesia: lidocaine 2% at doses of 50-70 mg was used for spinal anaesthesia.

PROCEDURE

Ligasure haemorrhoidectomy under local anesthesia

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

Sponsors & Collaborators

• Fundacio per la recerca e investigació del Hospital de Viladecans

  collaborator UNKNOWN

• Hospital de Viladecans

  lead OTHER

Principal Investigators

• Pi F Siques, Professor · Barcelona university of Medicine (Departement Ciencies Cliniques)

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Model

PARALLEL

Eligibility

Min Age

20 Years

Max Age

90 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2005-05-31

Primary Completion

2006-06-30

Completion

2007-06-30

Countries

• Spain

Study Locations