Ligasure Versus Diathermy Haemorrhoidectomy Under Local Anesthesia (LDHLA)

This study has been completed.
Sponsor:
Collaborator:
Fundacio per la recerca e investigació del Hospital de Viladecans
Information provided by:
Hospital de Viladecans
ClinicalTrials.gov Identifier:
NCT00617448
First received: February 5, 2008
Last updated: February 15, 2008
Last verified: February 2008
  Purpose

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).


Condition Intervention
Hemorrhoids
Procedure: diathermy haemorrhoidectomy under espinal anesthesia
Procedure: diathermy haemorrhoidectomy under local anesthesia
Procedure: Ligasure haemorrhoidetomy under spinal anestesia
Procedure: Ligasure haemorrhoidectomy under local anesthesia

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

Resource links provided by NLM:


Further study details as provided by Hospital de Viladecans:

Primary Outcome Measures:
  • all cause morbility within the first 7 days after surgery (consequence of surgery and anesthesia) and results sintomatology since 12 months [ Time Frame: at 2, 6, 24 horus, 7 days, 4 and 12 monts after surgery ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • intraoperative time, postoperative complications, pain (VAS), bleeding, pruritus and tenemus, continence ( score system of Jorge and Wexner), anal stenosis, presence of skin tags, degree of satisfaction and days of sick leave. [ Time Frame: Intraoperative, at 2,6,24 hours and 7 days after surgery and 4 and 12 monts after surgery ] [ Designated as safety issue: No ]

Enrollment: 81
Study Start Date: May 2005
Study Completion Date: June 2007
Primary Completion Date: June 2006 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: I
conventional diathermy haemorrhoidectomy under spinal anaesthesia
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.
Other Names:
  • diathermy excision haemorrhoids regional
  • open haemorrhoidectomy
  • regional anesthesia
Active Comparator: II
conventional diathermy haemorrhoidectomy with local anaesthesia combined with intravenous sedation (group II)
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
Other Names:
  • diathermy excision haemorrhoids regional
  • open haemorrhoidectomy
  • perianal anesthetics infiltration
  • pudendal block
Active Comparator: III
Ligasure haemorrhoidectomy under spinal anesthesia
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.
Other Names:
  • regional anesthesia
  • Ligasure for prolapsed piles
Active Comparator: IV
Ligasure haemorrhoidectomy under local anesthesia
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
Other Names:
  • Ligasure for prolapsed piles
  • Pudendal block

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.

  Eligibility

Ages Eligible for Study:   20 Years to 90 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT00617448

Locations
Spain
Hospital de Viladecans (Departement of surgery: coloproctology)
Viladecans, Barcelona, Spain, 08840
Sponsors and Collaborators
Hospital de Viladecans
Fundacio per la recerca e investigació del Hospital de Viladecans
Investigators
Principal Investigator: Pi F Siques, Professor Barcelona university of Medicine (Departement Ciencies Cliniques)
  More Information

Publications:

Responsible Party: Felip Pi Siques, Departement of Surgery
ClinicalTrials.gov Identifier: NCT00617448     History of Changes
Other Study ID Numbers: 05/0008
Study First Received: February 5, 2008
Last Updated: February 15, 2008
Health Authority: Spain: Ethics Committee

Keywords provided by Hospital de Viladecans:
diathermy hemorrhoids
Ligasure
randomized controlled trial
Postoperative pain
Surgical Procedure, Ambulatory
Local Anesthesia
Safety procedure long term
Day Surgery

Additional relevant MeSH terms:
Hemorrhoids
Rectal Diseases
Intestinal Diseases
Gastrointestinal Diseases
Digestive System Diseases
Vascular Diseases
Cardiovascular Diseases
Anesthetics
Ropivacaine
Central Nervous System Depressants
Physiological Effects of Drugs
Pharmacologic Actions
Central Nervous System Agents
Therapeutic Uses
Anesthetics, Local
Sensory System Agents
Peripheral Nervous System Agents

ClinicalTrials.gov processed this record on August 18, 2014