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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This study has been withdrawn prior to enrollment.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:
Information provided by:
University of Lausanne Hospitals
ClinicalTrials.gov Identifier:
NCT00512044
First received: August 6, 2007
Last updated: June 29, 2010
Last verified: July 2007
History of Changes
  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 Stade III
 Procedure: Local anesthesia (pudendal block)
Procedure: general anesthesia (spinal and general)
 Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Local vs General Anaesthesia in Stapled Hemorrhoidectomy: A Multicentric Controlled Randomized Trial

Resource links provided by NLM:

MedlinePlus related topics: Hemorrhoids
U.S. FDA Resources

Further study details as provided by University of Lausanne Hospitals:

Estimated Enrollment: 58
Study Start Date: October 2007
Estimated Study Completion Date: May 2008
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

Ages Eligible for Study:   18 Years to 90 Years
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

ClinicalTrials.gov Identifier: NCT00512044     History of Changes
Other Study ID Numbers: P07/CHV
Study First Received: August 6, 2007
Last Updated: June 29, 2010
Health Authority: Switzerland: Ethikkommission

Keywords provided by 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
Pharmacologic Actions
Central Nervous System Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on May 21, 2013