Local vs General Anaesthesia in Stapled Hemorrhoidectomy - Full Text View

Sponsored by:	University of Lausanne Hospitals
Information provided by:	University of Lausanne Hospitals
ClinicalTrials.gov Identifier:	NCT00512044

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
Hemorrhoids Stade III	Procedure: Local anesthesia (pudendal block) Procedure: general anesthesia (spinal and general)

MedlinePlus related topics: Anesthesia Hemorrhoids

U.S. FDA Resources

Study Type:	Observational
Study Design:	Screening, Cross-Sectional, Defined Population, Prospective Study
Official Title:	Local vs General Anaesthesia in Stapled Hemorrhoidectomy: A Multicentric Controlled Randomized Trial

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

Contacts

Contact: Sven Muller, MD	+41 21 314 2325	sven.muller@chuv.ch
Contact: Herni Vuilleumier, MD	+41 21 314 2350

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

Study ID Numbers:	P07/CHV
Study First Received:	August 6, 2007
Last Updated:	August 6, 2007
ClinicalTrials.gov Identifier:	NCT00512044
Health Authority:	Switzerland: Ethikkommission

Keywords provided by University of Lausanne Hospitals:

anesthesia, Longo, mucosectomy, hemorrhoids

Study placed in the following topic categories:

Digestive System Diseases
Gastrointestinal Diseases
Vascular Diseases

Hemorrhoids
Intestinal Diseases
Rectal Diseases

Additional relevant MeSH terms:

Cardiovascular Diseases

ClinicalTrials.gov processed this record on January 16, 2009