Home
Search
Study Topics
Glossary
|
|
|
|
|
Sponsors and Collaborators: |
Hospital de Viladecans Fundacio per la recerca e investigació del Hospital de Viladecans |
---|---|
Information provided by: | Hospital de Viladecans |
ClinicalTrials.gov Identifier: | NCT00617448 |
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: | Treatment, Randomized, Double Blind (Subject, Outcomes Assessor), Parallel Assignment, Safety/Efficacy Study |
Official Title: | Ligasure™ Versus Diathermy Haemorrhoidectomy Under Spinal or Local Anaesthesia With Ropivacaine. A Randomized Study With One Year Follow-up |
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 |
---|---|
I: Active Comparator
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.
|
II: Active Comparator
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
|
III: Active Comparator
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.
|
IV: Active Comparator
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
|
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
Ages Eligible for Study: | 20 Years to 90 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Spain, Barcelona | |
Hospital de Viladecans (Departement of surgery: coloproctology) | |
Viladecans, Barcelona, Spain, 08840 |
Principal Investigator: | Pi F Siques, Professor | Barcelona university of Medicine (Departement Ciencies Cliniques) |
Responsible Party: | Departement of Surgery ( Felip Pi Siques ) |
Study ID Numbers: | 05/0008 |
Study First Received: | February 5, 2008 |
Last Updated: | February 15, 2008 |
ClinicalTrials.gov Identifier: | NCT00617448 History of Changes |
Health Authority: | Spain: Ethics Committee |
diathermy hemorrhoids Ligasure randomized controlled trial Postoperative pain |
Surgical Procedure, Ambulatory Local Anesthesia Safety procedure long term Day Surgery |
Remifentanil Gastrointestinal Diseases Ropivacaine Vascular Diseases Lidocaine Anesthetics Central Nervous System Depressants |
Pain Intestinal Diseases Rectal Diseases Digestive System Diseases Hemorrhoids Pain, Postoperative |
Gastrointestinal Diseases Physiological Effects of Drugs Vascular Diseases Anesthetics Central Nervous System Depressants Intestinal Diseases Rectal Diseases |
Pharmacologic Actions Digestive System Diseases Therapeutic Uses Hemorrhoids Cardiovascular Diseases Central Nervous System Agents |