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Local Versus General Anaesthesia in Stapled Hemorrhoidectomy

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.
 
ClinicalTrials.gov Identifier: NCT00512044
Recruitment Status : Withdrawn (slow recruitment, internal problems with the study protocol)
First Posted : August 7, 2007
Last Update Posted : March 2, 2020
Sponsor:
Information provided by (Responsible Party):
Nicolas DEMARTINES, University of Lausanne Hospitals

Tracking Information
First Submitted Date  ICMJE August 6, 2007
First Posted Date  ICMJE August 7, 2007
Last Update Posted Date March 2, 2020
Study Start Date  ICMJE October 2007
Actual Primary Completion Date November 2007   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE Not Provided
Original Primary Outcome Measures  ICMJE Not Provided
Change History
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Local Versus General Anaesthesia in Stapled Hemorrhoidectomy
Official Title  ICMJE Local vs General Anaesthesia in Stapled Hemorrhoidectomy: A Multicentric Controlled Randomized Trial
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.
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 Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Hemorrhoids
Intervention  ICMJE
  • 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
Study Arms  ICMJE
  • 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)
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Withdrawn
Actual Enrollment  ICMJE
 (submitted: June 23, 2015)
0
Original Estimated Enrollment  ICMJE
 (submitted: August 6, 2007)
58
Estimated Study Completion Date  ICMJE May 2008
Actual Primary Completion Date November 2007   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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).
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 90 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Switzerland
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00512044
Other Study ID Numbers  ICMJE P07/CHV
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Nicolas DEMARTINES, University of Lausanne Hospitals
Study Sponsor  ICMJE University of Lausanne Hospitals
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Chair: Nicolas Demartines, MD Department of Visceral Surgery, University Hospital Center, Lausanne, Switzerland
PRS Account University of Lausanne Hospitals
Verification Date February 2020

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