Ligasure Versus Diathermy Haemorrhoidectomy Under Local Anesthesia (LDHLA)
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| ClinicalTrials.gov Identifier: NCT00617448 |
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Recruitment Status :
Completed
First Posted : February 18, 2008
Last Update Posted : February 18, 2008
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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).
| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| 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 | Not Applicable |
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 (Clinical Trial) |
| Actual Enrollment : | 81 participants |
| Allocation: | Randomized |
| Intervention Model: | Parallel Assignment |
| Masking: | Double (Participant, 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 |
| Study Start Date : | May 2005 |
| Actual Primary Completion Date : | June 2006 |
| Actual Study Completion Date : | June 2007 |
| Arm | Intervention/treatment |
|---|---|
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Active Comparator: I
conventional diathermy haemorrhoidectomy under spinal anaesthesia
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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:
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Active Comparator: II
conventional diathermy haemorrhoidectomy with local anaesthesia combined with intravenous sedation (group II)
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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:
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Active Comparator: III
Ligasure haemorrhoidectomy under spinal anesthesia
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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:
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Active Comparator: IV
Ligasure haemorrhoidectomy under local anesthesia
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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:
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- 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 ]
- 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 ]
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| Ages Eligible for Study: | 20 Years to 90 Years (Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00617448
| Spain | |
| Hospital de Viladecans (Departement of surgery: coloproctology) | |
| Viladecans, Barcelona, Spain, 08840 | |
| Principal Investigator: | Pi F Siques, Professor | Barcelona university of Medicine (Departement Ciencies Cliniques) |
Publications of Results:
| Responsible Party: | Felip Pi Siques, Departement of Surgery |
| ClinicalTrials.gov Identifier: | NCT00617448 History of Changes |
| Other Study ID Numbers: |
05/0008 |
| First Posted: | February 18, 2008 Key Record Dates |
| Last Update Posted: | February 18, 2008 |
| Last Verified: | February 2008 |
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diathermy hemorrhoids Ligasure randomized controlled trial Postoperative pain |
Surgical Procedure, Ambulatory Local Anesthesia Safety procedure long term Day Surgery |
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Hemorrhoids Rectal Diseases Intestinal Diseases Gastrointestinal Diseases Digestive System Diseases Vascular Diseases Cardiovascular Diseases |
Anesthetics Ropivacaine Central Nervous System Depressants Physiological Effects of Drugs Anesthetics, Local Sensory System Agents Peripheral Nervous System Agents |