Ligasure Versus Diathermy Haemorrhoidectomy Under Local Anesthesia

NCT00617448 | Completed DMC

• 1 other identifier: 05/0008
• Study Type: interventional
• Target: 81
• Locations: 1 country
• Sites: 1

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).

Conditions

Hemorrhoids

Keywords

diathermy hemorrhoids; Ligasure; randomized controlled trial; Postoperative pain; Surgical Procedure, Ambulatory; Local Anesthesia; Safety procedure long term; Day Surgery

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• 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

Study Arms (4)

I

ACTIVE COMPARATOR

conventional diathermy haemorrhoidectomy under spinal anaesthesia

Procedure: diathermy haemorrhoidectomy under espinal anesthesia

II

ACTIVE COMPARATOR

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

Procedure: diathermy haemorrhoidectomy under local anesthesia

III

ACTIVE COMPARATOR

Ligasure haemorrhoidectomy under spinal anesthesia

Procedure: Ligasure haemorrhoidetomy under spinal anestesia

IV

ACTIVE COMPARATOR

Ligasure haemorrhoidectomy under local anesthesia

Procedure: Ligasure haemorrhoidectomy under local anesthesia

Interventions

diathermy haemorrhoidectomy under espinal anesthesia PROCEDURE

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

Also known as: diathermy excision haemorrhoids regional, open haemorrhoidectomy, regional anesthesia

I

diathermy haemorrhoidectomy under local anesthesia 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

Also known as: diathermy excision haemorrhoids regional, open haemorrhoidectomy, perianal anesthetics infiltration, pudendal block

II

Ligasure haemorrhoidetomy under spinal anestesia PROCEDURE

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

Also known as: regional anesthesia, Ligasure for prolapsed piles

III

Ligasure haemorrhoidectomy under local anesthesia 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

Also known as: Ligasure for prolapsed piles, Pudendal block

IV

Eligibility Criteria

• Age: 20 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• patients with a long-standing history of symptomatic grade III or IV haemorrhoids

You may not qualify if:

• 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.

Sponsors & Collaborators

• Hospital de Viladecans: lead
• Fundacio per la recerca e investigació del Hospital de Viladecans: collaborator

Study Sites (1)

Hospital de Viladecans (Departement of surgery: coloproctology)

Viladecans, Barcelona, 08840, Spain

Location

Related Publications (9)

• 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.

  PMID: 11952582 RESULT

• 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.

  PMID: 11856126 RESULT

• 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.

  PMID: 15932557 RESULT

• 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.

  PMID: 15573239 RESULT

• 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.

  PMID: 10953578 RESULT

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

  PMID: 16518980 RESULT

• 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.

  PMID: 11786772 RESULT

• 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.

  PMID: 15875295 RESULT

• 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.

  PMID: 17119982 RESULT

MeSH Terms

Conditions

Hemorrhoids; Pain, Postoperative

Interventions

Anesthesia, Conduction

Condition Hierarchy (Ancestors)

Rectal Diseases; Intestinal Diseases; Gastrointestinal Diseases; Digestive System Diseases; Vascular Diseases; Cardiovascular Diseases; Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pain; Neurologic Manifestations; Signs and Symptoms

Intervention Hierarchy (Ancestors)

Anesthesia; Anesthesia and Analgesia

Study Officials

• Pi F Siques, Professor

  Barcelona university of Medicine (Departement Ciencies Cliniques)

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: February 5, 2008
• First Posted: February 18, 2008
• Study Start: May 1, 2005
• Primary Completion: June 1, 2006
• Study Completion: June 1, 2007
• Last Updated: February 18, 2008

Record last verified: 2008-02

Locations

ES (1)