Local Versus General Anaesthesia in Stapled Hemorrhoidectomy

Phase 4

Withdrawn

• Conditions: Hemorrhoids
• Interventions: Procedure: general anesthesia (spinal and general); Procedure: Local anesthesia (pudendal block)

• Registration Number: NCT00512044
• Lead Sponsor: 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.

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 Timeline

• Study First Submitted: 2007-08-06
• Study First Submitted QC: 2007-08-06
• Study First Posted: 2007-08-07
• Study Start: 2007-10
• Primary Completion: 2007-11
• Study Completion: 2008-05
• Status Verified: 2020-02
• Last Update Submitted: 2020-02-28
• Last Update Posted: 2020-03-02

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
A: general	general anesthesia (spinal and general)	general anesthesia: spinal and general
B: pudendal	Local anesthesia (pudendal block)	local anesthesia: pudendal block

Trial Locations

Locations (1)

Department of Visceral Surgery, University Hospital Center; 🇨🇭 Lausanne, Switzerland