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Local Versus General Anaesthesia in Stapled Hemorrhoidectomy

Primary Purpose

Hemorrhoids

Status
Withdrawn
Phase
Phase 4
Locations
Switzerland
Study Type
Interventional
Intervention
Local anesthesia (pudendal block)
general anesthesia (spinal and general)
Sponsored by
University of Lausanne Hospitals
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Hemorrhoids focused on measuring anesthesia, Longo, mucosectomy, hemorrhoids

Eligibility Criteria

18 Years - 90 Years (Adult, Older Adult)All SexesDoes not accept 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).

Sites / Locations

  • Department of Visceral Surgery, University Hospital Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

A: general

B: pudendal

Arm Description

general anesthesia: spinal and general

local anesthesia: pudendal block

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

First Posted
August 6, 2007
Last Updated
February 28, 2020
Sponsor
University of Lausanne Hospitals
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1. Study Identification

Unique Protocol Identification Number
NCT00512044
Brief Title
Local Versus General Anaesthesia in Stapled Hemorrhoidectomy
Official Title
Local vs General Anaesthesia in Stapled Hemorrhoidectomy: A Multicentric Controlled Randomized Trial
Study Type
Interventional

2. Study Status

Record Verification Date
February 2020
Overall Recruitment Status
Withdrawn
Why Stopped
slow recruitment, internal problems with the study protocol
Study Start Date
October 2007 (undefined)
Primary Completion Date
November 2007 (Actual)
Study Completion Date
May 2008 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Lausanne Hospitals

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hemorrhoids
Keywords
anesthesia, Longo, mucosectomy, hemorrhoids

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
0 (Actual)

8. Arms, Groups, and Interventions

Arm Title
A: general
Arm Type
Active Comparator
Arm Description
general anesthesia: spinal and general
Arm Title
B: pudendal
Arm Type
Experimental
Arm Description
local anesthesia: pudendal block
Intervention Type
Procedure
Intervention Name(s)
Local anesthesia (pudendal block)
Other Intervention Name(s)
local
Intervention Description
local anesthesia as indicated
Intervention Type
Procedure
Intervention Name(s)
general anesthesia (spinal and general)
Other Intervention Name(s)
general
Intervention Description
general according to guidelines

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
90 Years
Accepts Healthy Volunteers
No
Eligibility 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).
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Nicolas Demartines, MD
Organizational Affiliation
Department of Visceral Surgery, University Hospital Center, Lausanne, Switzerland
Official's Role
Study Chair
Facility Information:
Facility Name
Department of Visceral Surgery, University Hospital Center
City
Lausanne
ZIP/Postal Code
1011
Country
Switzerland

12. IPD Sharing Statement

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Local Versus General Anaesthesia in Stapled Hemorrhoidectomy

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