Ligasure Versus Diathermy Haemorrhoidectomy Under Local Anesthesia

Study Overview
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Brief Summary
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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).

Detailed Description
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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.

Official Title
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Ligasure™ Versus Diathermy Haemorrhoidectomy Under Spinal or Local Anaesthesia With Ropivacaine. A Randomized Study With One Year Follow-up

Conditions
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Hemorrhoids

Intervention / Treatment
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* Procedure: diathermy haemorrhoidectomy under espinal anesthesia
* Procedure: diathermy haemorrhoidectomy under local anesthesia
* Procedure: Ligasure haemorrhoidetomy under spinal anestesia
* Procedure: Ligasure haemorrhoidectomy under local anesthesia


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 90 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: I<br>conventional diathermy haemorrhoidectomy under spinal anaesthesia | Procedure: diathermy haemorrhoidectomy under espinal anesthesia<br>* For surgery: conventional haemorrhoidectomy with diathermy (Milligan-Morgan).For anesthesia: lidocaine 2% at doses of 50-70 mg was used for spinal anaesthesia.<br>* Other names: regional anesthesia;|
| Active Comparator: II<br>conventional diathermy haemorrhoidectomy with local anaesthesia combined with intravenous sedation (group II) | Procedure: diathermy haemorrhoidectomy under local anesthesia<br>* 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<br>* Other names: pudendal block;|
| Active Comparator: III<br>Ligasure haemorrhoidectomy under spinal anesthesia | Procedure: Ligasure haemorrhoidetomy under spinal anestesia<br>* For surgery: ligasure haemorrhoidectomy For anesthesia: lidocaine 2% at doses of 50-70 mg was used for spinal anaesthesia.<br>* Other names: Ligasure for prolapsed piles;|
| Active Comparator: IV<br>Ligasure haemorrhoidectomy under local anesthesia | Procedure: Ligasure haemorrhoidectomy under local anesthesia<br>* 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<br>* Other names: Pudendal block;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| all cause morbility within the first 7 days after surgery (consequence of surgery and anesthesia) and results sintomatology since 12 months |  | at 2, 6, 24 horus, 7 days, 4 and 12 monts after surgery | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | 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. |  | Intraoperative, at 2,6,24 hours and 7 days after surgery and 4 and 12 monts after surgery | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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diathermy hemorrhoids, Ligasure, randomized controlled trial, Postoperative pain, Surgical Procedure, Ambulatory, Local Anesthesia, Safety procedure long term, Day Surgery