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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This study has been withdrawn prior to enrollment.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
  Purpose
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 Intervention Phase
Hemorrhoids Procedure: Local anesthesia (pudendal block) Procedure: general anesthesia (spinal and general) Phase 4

Study Type: Interventional
Study Design: 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

Resource links provided by NLM:


Further study details as provided by Nicolas DEMARTINES, University of Lausanne Hospitals:

Enrollment: 0
Study Start Date: October 2007
Estimated Study Completion Date: May 2008
Primary Completion Date: November 2007 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: A: general
general anesthesia: spinal and general
Procedure: general anesthesia (spinal and general)
general according to guidelines
Other Name: general
Experimental: B: pudendal
local anesthesia: pudendal block
Procedure: Local anesthesia (pudendal block)
local anesthesia as indicated
Other Name: local

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.

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 90 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00512044


Locations
Switzerland
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
  More Information

Responsible Party: Nicolas DEMARTINES, investigator, University of Lausanne Hospitals
ClinicalTrials.gov Identifier: NCT00512044     History of Changes
Other Study ID Numbers: P07/CHV
First Submitted: August 6, 2007
First Posted: August 7, 2007
Last Update Posted: June 24, 2015
Last Verified: June 2015

Keywords provided by Nicolas DEMARTINES, University of Lausanne Hospitals:
anesthesia, Longo, mucosectomy, hemorrhoids

Additional relevant MeSH terms:
Hemorrhoids
Rectal Diseases
Intestinal Diseases
Gastrointestinal Diseases
Digestive System Diseases
Vascular Diseases
Cardiovascular Diseases
Anesthetics
Central Nervous System Depressants
Physiological Effects of Drugs