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Recruitment Status : Withdrawn (slow recruitment, internal problems with the study protocol)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

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
Hemorrhoids 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.

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Study Type : Interventional  (Clinical Trial)
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 : October 2007
Actual Primary Completion Date : November 2007
Estimated Study Completion Date : May 2008

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Hemorrhoids

Arm Intervention/treatment
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

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 90 Years   (Adult, Older Adult)
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).

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 identifier (NCT number): NCT00512044

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Department of Visceral Surgery, University Hospital Center
Lausanne, Switzerland, 1011
Sponsors and Collaborators
University of Lausanne Hospitals
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Study Chair: Nicolas Demartines, MD Department of Visceral Surgery, University Hospital Center, Lausanne, Switzerland
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Responsible Party: Nicolas DEMARTINES, investigator, University of Lausanne Hospitals Identifier: NCT00512044    
Other Study ID Numbers: P07/CHV
First Posted: August 7, 2007    Key Record Dates
Last Update Posted: March 2, 2020
Last Verified: February 2020
Keywords provided by Nicolas DEMARTINES, University of Lausanne Hospitals:
anesthesia, Longo, mucosectomy, hemorrhoids
Additional relevant MeSH terms:
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Rectal Diseases
Intestinal Diseases
Gastrointestinal Diseases
Digestive System Diseases
Vascular Diseases
Cardiovascular Diseases
Central Nervous System Depressants
Physiological Effects of Drugs