Hemorrhoids Clinical Trial
— LDHLAOfficial title:
Ligasure™ Versus Diathermy Haemorrhoidectomy Under Spinal or Local Anaesthesia With Ropivacaine. A Randomized Study With One Year Follow-up
Verified date | February 2008 |
Source | Hospital de Viladecans |
Contact | n/a |
Is FDA regulated | No |
Health authority | Spain: Ethics Committee |
Study type | Interventional |
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).
Status | Completed |
Enrollment | 81 |
Est. completion date | June 2007 |
Est. primary completion date | June 2006 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 20 Years to 90 Years |
Eligibility |
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. |
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Outcomes Assessor), Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
Spain | Hospital de Viladecans (Departement of surgery: coloproctology) | Viladecans | Barcelona |
Lead Sponsor | Collaborator |
---|---|
Hospital de Viladecans | Fundacio per la recerca e investigació del Hospital de Viladecans |
Spain,
Basdanis G, Papadopoulos VN, Michalopoulos A, Apostolidis S, Harlaftis N. Randomized clinical trial of stapled hemorrhoidectomy vs open with Ligasure for prolapsed piles. Surg Endosc. 2005 Feb;19(2):235-9. Epub 2004 Dec 2. — View Citation
Haveran LA, Sturrock PR, Sun MY, McDade J, Singla S, Paterson CA, Counihan TC. Simple harmonic scalpel hemorrhoidectomy utilizing local anesthesia combined with intravenous sedation: a safe and rapid alternative to conventional hemorrhoidectomy. Int J Col — View Citation
Jayne DG, Botterill I, Ambrose NS, Brennan TG, Guillou PJ, O'Riordain DS. Randomized clinical trial of Ligasure versus conventional diathermy for day-case haemorrhoidectomy. Br J Surg. 2002 Apr;89(4):428-32. — View Citation
Kim J, Lee DS, Jang SM, Shim MC, Jee DL. The effect of pudendal block on voiding after hemorrhoidectomy. Dis Colon Rectum. 2005 Mar;48(3):518-23. — View Citation
Lohsiriwat D, Lohsiriwat V. Outpatient hemorrhoidectomy under perianal anesthetics infiltration. J Med Assoc Thai. 2005 Dec;88(12):1821-4. — View Citation
Masoni L, La Torre F, Otti M, Pascarella G, Gasparrini M, Riso V, Cottini F, Montori A. [Hemorrhoidectomy with ropivacaine (Naropin) local anesthesia. Preliminary experience]. Minerva Chir. 2000 May;55(5):383-7. Italian. — View Citation
Palazzo FF, Francis DL, Clifton MA. Randomized clinical trial of Ligasure versus open haemorrhoidectomy. Br J Surg. 2002 Feb;89(2):154-7. — View Citation
Peters CJ, Botterill I, Ambrose NS, Hick D, Casey J, Jayne DG. Ligasure trademark vs conventional diathermy haemorrhoidectomy: long-term follow-up of a randomised clinical trial. Colorectal Dis. 2005 Jul;7(4):350-3. — View Citation
Vinson-Bonnet B, Coltat JC, Fingerhut A, Bonnet F. Local infiltration with ropivacaine improves immediate postoperative pain control after hemorrhoidal surgery. Dis Colon Rectum. 2002 Jan;45(1):104-8. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 | No | |
Secondary | 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 | No |
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