- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00512044
Local Versus General Anaesthesia in Stapled Hemorrhoidectomy
Local vs General Anaesthesia in Stapled Hemorrhoidectomy: A Multicentric Controlled Randomized Trial
Study Overview
Status
Conditions
Intervention / Treatment
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
Phase
- Phase 4
Contacts and Locations
Study Locations
-
-
-
Lausanne, Switzerland, 1011
- Department of Visceral Surgery, University Hospital Center
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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).
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: A: general
general anesthesia: spinal and general
|
general according to guidelines
Other Names:
|
Experimental: B: pudendal
local anesthesia: pudendal block
|
local anesthesia as indicated
Other Names:
|
Collaborators and Investigators
Sponsor
Investigators
- Study Chair: Nicolas Demartines, MD, Department of Visceral Surgery, University Hospital Center, Lausanne, Switzerland
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- P07/CHV
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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