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Local Versus General Anaesthesia in Stapled Hemorrhoidectomy

Sponsor
University of Lausanne Hospitals (Other)
Overall Status
Withdrawn
CT.gov ID
NCT00512044
Collaborator
(none)
0
Enrollment
1
Location
2
Arms
7
Duration (Months)
0
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

The purpose of this study is to determine whether local or general anaesthesia in stapled hemorrhoidectomy leads to a shorter operation time with a better patient comfort.

Condition or Disease Intervention/Treatment Phase
  • Procedure: Local anesthesia (pudendal block)
  • Procedure: general anesthesia (spinal and general)
 Phase 4

Detailed Description

Hemorrhoids are a frequent disease with the need of surgical intervention in 10-20% of the patients. The stapled hemorrhoidectomy according to Longo under general anesthesia (or spinal) is considered standard of care [1]. Cohort studies show that a pudendal bloc with local anesthesia is safe and efficient [2-4]. The majority of procedures are actually performed in private clinics or in an ambulatory setting underlining the importance of economic issues such as procedure time (anesthesia and operation time) and hospital stay.

We hypothesize that stapled hemorrhoidectomy under local anaesthesia shortens anaesthesia time and hospital stay and reduces costs with no disadvantages regarding pain, satisfaction and complication rate.

Study Design

Study Type:
Interventional
Actual Enrollment :
0 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
Local vs General Anaesthesia in Stapled Hemorrhoidectomy: A Multicentric Controlled Randomized Trial
Study Start Date :
Oct 1, 2007
Actual Primary Completion Date :
Nov 1, 2007
Anticipated Study Completion Date :
May 1, 2008

Arms and Interventions

Arm Intervention/Treatment
Active Comparator: A: general

general anesthesia: spinal and general

Procedure: general anesthesia (spinal and general)
general according to guidelines
Other Names:
  • general

    		•
    Experimental: B: pudendal

    local anesthesia: pudendal block

    Procedure: Local anesthesia (pudendal block)
    local anesthesia as indicated
    Other Names:
  • local

    		•

    Outcome Measures

    Primary Outcome Measures

      Eligibility Criteria

      Criteria

      Ages Eligible for Study:
      18 Years to 90 Years
      Sexes Eligible for Study:
      All
      Accepts Healthy Volunteers:
      No
      Inclusion Criteria:
      • Hemorrhoids grade III suitable for elective stapled hemorrhoidectomy
      Exclusion Criteria:

      • Age < 18 years

      • No informed consent

      • Emergency situation

      • Contraindication to either anaesthesia method

      • Patients not speaking french or german.

      • Additional anal pathology (fissure, tumour).

      Contacts and Locations

      Locations

      Site City State Country Postal Code
      1 Department of Visceral Surgery, University Hospital Center Lausanne Switzerland 1011

      Sponsors and Collaborators

      • University of Lausanne Hospitals

      Investigators

      • Study Chair: Nicolas Demartines, MD, Department of Visceral Surgery, University Hospital Center, Lausanne, Switzerland

      Study Documents (Full-Text)

      None provided.

      More Information

      Publications

      None provided.
      Responsible Party:
      Nicolas DEMARTINES, investigator, University of Lausanne Hospitals
      ClinicalTrials.gov Identifier:
      NCT00512044
      Other Study ID Numbers:
      • P07/CHV
      First Posted:
      Aug 7, 2007
      Last Update Posted:
      Mar 2, 2020
      Last Verified:
      Feb 1, 2020
      Keywords provided by Nicolas DEMARTINES, investigator, University of Lausanne Hospitals
      anesthesia, Longo, mucosectomy, hemorrhoids
      Additional relevant MeSH terms:
      Hemorrhoids
      Anesthetics

      Study Results

      No Results Posted as of Mar 2, 2020