Local Versus General Anaesthesia in Stapled Hemorrhoidectomy

Hemorrhoids Clinical Trial

Official title:

Local vs General Anaesthesia in Stapled Hemorrhoidectomy: A Multicentric Controlled Randomized Trial

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT00512044
• Other study ID #: P07/CHV
• Status: Withdrawn
• Phase: Phase 4
• Start date: October 2007
• Est. completion date: May 2008

Study information

• Verified date: February 2020
• Source: University of Lausanne Hospitals
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: May 2008
• Est. primary completion date: November 2007
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 90 Years

Eligibility

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).

Related Conditions & MeSH terms

• Hemorrhoids

Intervention

Procedure:
• Local anesthesia (pudendal block)
local anesthesia as indicated
• general anesthesia (spinal and general)
general according to guidelines

Locations

Country	Name	City	State
Switzerland	Department of Visceral Surgery, University Hospital Center	Lausanne

Sponsors (1)

Lead Sponsor	Collaborator
University of Lausanne Hospitals

Country where clinical trial is conducted

Switzerland,