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Local Versus General Anaesthesia in Stapled Hemorrhoidectomy

This study has been withdrawn prior to enrollment.
(slow recruitment, internal problems with the study protocol)
Sponsor:
ClinicalTrials.gov Identifier:
NCT00512044
First Posted: August 7, 2007
Last Update Posted: June 24, 2015
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Nicolas DEMARTINES, University of Lausanne Hospitals
August 6, 2007
August 7, 2007
June 24, 2015
October 2007
November 2007   (Final data collection date for primary outcome measure)
Not Provided
Not Provided
Complete list of historical versions of study NCT00512044 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
Not Provided
Not Provided
 
Local Versus General Anaesthesia in Stapled Hemorrhoidectomy
Local vs General Anaesthesia in Stapled Hemorrhoidectomy: A Multicentric Controlled Randomized Trial
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.

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.

Interventional
Phase 4
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Hemorrhoids
  • Procedure: Local anesthesia (pudendal block)
    local anesthesia as indicated
    Other Name: local
  • Procedure: general anesthesia (spinal and general)
    general according to guidelines
    Other Name: general
  • Active Comparator: A: general
    general anesthesia: spinal and general
    Intervention: Procedure: general anesthesia (spinal and general)
  • Experimental: B: pudendal
    local anesthesia: pudendal block
    Intervention: Procedure: Local anesthesia (pudendal block)
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Withdrawn
0
May 2008
November 2007   (Final data collection date for primary outcome measure)

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).
Sexes Eligible for Study: All
18 Years to 90 Years   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
Switzerland
 
 
NCT00512044
P07/CHV
No
Not Provided
Not Provided
Nicolas DEMARTINES, University of Lausanne Hospitals
University of Lausanne Hospitals
Not Provided
Study Chair: Nicolas Demartines, MD Department of Visceral Surgery, University Hospital Center, Lausanne, Switzerland
University of Lausanne Hospitals
June 2015

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP