Ligasure Versus Diathermy Haemorrhoidectomy Under Local Anesthesia

NCT ID: NCT00617448

Last Updated: 2008-02-18

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 81 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2005-05-31
• Study Completion Date: 2007-06-30

Brief Summary

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

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.

Conditions

Hemorrhoids

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

I

conventional diathermy haemorrhoidectomy under spinal anaesthesia

Group Type: ACTIVE_COMPARATOR

diathermy haemorrhoidectomy under espinal anesthesia

Intervention Type: PROCEDURE

For surgery: conventional haemorrhoidectomy with diathermy (Milligan-Morgan).For anesthesia: lidocaine 2% at doses of 50-70 mg was used for spinal anaesthesia.

II

conventional diathermy haemorrhoidectomy with local anaesthesia combined with intravenous sedation (group II)

Group Type: ACTIVE_COMPARATOR

diathermy haemorrhoidectomy under local anesthesia

Intervention Type: PROCEDURE

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

Ligasure haemorrhoidectomy under spinal anesthesia

Group Type: ACTIVE_COMPARATOR

Ligasure haemorrhoidetomy under spinal anestesia

Intervention Type: PROCEDURE

For surgery: ligasure haemorrhoidectomy For anesthesia: lidocaine 2% at doses of 50-70 mg was used for spinal anaesthesia.

IV

Ligasure haemorrhoidectomy under local anesthesia

Group Type: ACTIVE_COMPARATOR

Ligasure haemorrhoidectomy under local anesthesia

Intervention Type: PROCEDURE

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

Interventions

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.

Intervention Type: 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

Intervention Type: 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.

Intervention Type: 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

Intervention Type: PROCEDURE

Other Intervention Names

diathermy excision haemorrhoids regional; open haemorrhoidectomy; regional anesthesia; diathermy excision haemorrhoids regional; open haemorrhoidectomy; perianal anesthetics infiltration; pudendal block; regional anesthesia; Ligasure for prolapsed piles; Ligasure for prolapsed piles; Pudendal block

Eligibility Criteria

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.

• Minimum Eligible Age: 20 Years
• Maximum Eligible Age: 90 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Fundacio per la recerca e investigació del Hospital de Viladecans

UNKNOWN

Sponsor Role: collaborator

Hospital de Viladecans

OTHER

Sponsor Role: lead

Responsible Party

Departement of Surgery

Principal Investigators

Pi F Siques, Professor

Role: PRINCIPAL_INVESTIGATOR

Barcelona university of Medicine (Departement Ciencies Cliniques)

Locations

Hospital de Viladecans (Departement of surgery: coloproctology)

Viladecans, Barcelona, Spain

Countries

Spain

References

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. doi: 10.1046/j.0007-1323.2002.02056.x.

Reference Type: RESULT

PMID: 11952582 (View on PubMed)

Palazzo FF, Francis DL, Clifton MA. Randomized clinical trial of Ligasure versus open haemorrhoidectomy. Br J Surg. 2002 Feb;89(2):154-7. doi: 10.1046/j.0007-1323.2001.01993.x.

Reference Type: RESULT

PMID: 11856126 (View on PubMed)

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. doi: 10.1111/j.1463-1318.2005.00817.x.

Reference Type: RESULT

PMID: 15932557 (View on PubMed)

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. doi: 10.1007/s00464-004-9098-0. Epub 2004 Dec 2.

Reference Type: RESULT

PMID: 15573239 (View on PubMed)

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.

Reference Type: RESULT

PMID: 10953578 (View on PubMed)

Lohsiriwat D, Lohsiriwat V. Outpatient hemorrhoidectomy under perianal anesthetics infiltration. J Med Assoc Thai. 2005 Dec;88(12):1821-4.

Reference Type: RESULT

PMID: 16518980 (View on PubMed)

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. doi: 10.1007/s10350-004-6121-4.

Reference Type: RESULT

PMID: 11786772 (View on PubMed)

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. doi: 10.1007/s10350-004-0798-2.

Reference Type: RESULT

PMID: 15875295 (View on PubMed)

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 Colorectal Dis. 2007 Jul;22(7):801-6. doi: 10.1007/s00384-006-0242-2. Epub 2006 Nov 22.

Reference Type: RESULT

PMID: 17119982 (View on PubMed)

Other Identifiers

05/0008

Identifier Type: -

Identifier Source: org_study_id