Ligasure Versus Diathermy Haemorrhoidectomy Under Local Anesthesia (LDHLA)

February 15, 2008 updated by: Hospital de Viladecans

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).

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

81

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Spain
    • Barcelona
      • Viladecans, Barcelona, Spain, 08840
        • Hospital de Viladecans (Departement of surgery: coloproctology)

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years to 90 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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:
  • regional anesthesia
  • diathermy excision haemorrhoids regional
  • open haemorrhoidectomy
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
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
at 2, 6, 24 horus, 7 days, 4 and 12 monts after surgery

Secondary Outcome Measures

Outcome Measure
Time Frame
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
Intraoperative, at 2,6,24 hours and 7 days after surgery and 4 and 12 monts after surgery

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Hospital de Viladecans

Collaborators

Fundacio per la recerca e investigació del Hospital de Viladecans

Investigators

  • Principal Investigator: Pi F Siques, Professor, Barcelona university of Medicine (Departement Ciencies Cliniques)

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 2005

Primary Completion (Actual)

June 1, 2006

Study Completion (Actual)

June 1, 2007

Study Registration Dates

First Submitted

February 5, 2008

First Submitted That Met QC Criteria

February 15, 2008

First Posted (Estimate)

February 18, 2008

Study Record Updates

Last Update Posted (Estimate)

February 18, 2008

Last Update Submitted That Met QC Criteria

February 15, 2008

Last Verified

February 1, 2008

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 05/0008

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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