Local Versus General Anaesthesia in Stapled Hemorrhoidectomy | NCT00512044

Studies
Local Versus General Anaesthesia in Stapled Hemorrhoidectomy

NCT00512044

Sponsor

University of Lausanne Hospitals

Status

Withdrawn

Last Update Posted

Mar 2, 2020Actual

Enrollment

0Actual

Phase

Phase 4

Conditions

Hemorrhoids

Interventions

Local anesthesia (pudendal block)
general anesthesia (spinal and general)

Countries

Switzerland

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Feb 2020

Overall Recruitment Status or Expanded Access Status

Withdrawn

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

slow recruitment, internal problems with the study protocol

Expanded Access Info

Start Date

Oct 2007

Primary Completion Date

Nov 2007Actual

Completion Date

May 2008Estimated

First Submitted Date

Aug 6, 2007

First Submission Date that Met QC Criteria

Aug 6, 2007

First Posted Date

Aug 7, 2007Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Feb 28, 2020

Last Update Posted Date

Mar 2, 2020Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 4

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

0Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
A: general	Active Comparator	general anesthesia: spinal and general	Procedure: general anesthesia (spinal and general)
B: pudendal	Experimental	local anesthesia: pudendal block	Procedure: Local anesthesia (pudendal block)

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Local anesthesia (pudendal block)	Procedure	local anesthesia as indicated	B: pudendal

Eligibility Module

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).

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

90 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Nicolas Demartines, MD	Department of Visceral Surgery, University Hospital Center, Lausanne, Switzerland	Study Chair

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Department of Visceral Surgery, University Hospital Center		Lausanne		1011	Switzerland

Condition Browse Module

MeSH Terms

ID	Term
D006484	Hemorrhoids

Ancestor Terms

ID	Term
D012002	Rectal Diseases
D007410	Intestinal Diseases
D005767	Gastrointestinal Diseases
D004066	Digestive System Diseases

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D000772	Anesthesia, Local
D000768	Anesthesia, General

Ancestor Terms

ID	Term
D000765	Anesthesia, Conduction
D000758	Anesthesia
D000760	Anesthesia and Analgesia

Browse Leaves

Not provided

Browse Branches

Not provided