Local Versus General Anaesthesia in Stapled Hemorrhoidectomy

Lausanne University Hospital (CHUV)

Status and phase: Withdrawn; Phase 4

Conditions: Hemorrhoids

Treatments: Procedure: Local anesthesia (pudendal block); Procedure: general anesthesia (spinal and general)

Study type: Interventional

Funder types: Other

Identifiers

NCT00512044

P07/CHV

Details and patient eligibility

About

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.

Full 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.

Sex: All

Ages: 18 to 90 years old

Volunteers: No Healthy Volunteers

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).

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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0 participants in 2 patient groups

A: general

Active Comparator group

Description:

general anesthesia: spinal and general

Treatment:

Procedure: general anesthesia (spinal and general)

B: pudendal

Experimental group

Description:

local anesthesia: pudendal block

Treatment:

Procedure: Local anesthesia (pudendal block)