NCT00512044

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.

Trial Health

30
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Timeline
Completed

Started Oct 2007

Shorter than P25 for phase_4

Geographic Reach
1 country

1 active site

Status
withdrawn

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 6, 2007

Completed
1 day until next milestone

First Posted

Study publicly available on registry

August 7, 2007

Completed
2 months until next milestone

Study Start

First participant enrolled

October 1, 2007

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2007

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2008

Completed
Last Updated

March 2, 2020

Status Verified

February 1, 2020

Enrollment Period

1 month

First QC Date

August 6, 2007

Last Update Submit

February 28, 2020

Conditions

Hemorrhoids

Keywords

anesthesia, Longo, mucosectomy, hemorrhoids

Study Arms (2)

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

Local anesthesia (pudendal block)PROCEDURE

local anesthesia as indicated

Also known as: local
B: pudendal
general anesthesia (spinal and general)PROCEDURE

general according to guidelines

Also known as: general
A: general

Eligibility Criteria

Age18 Years - 90 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Hemorrhoids grade III suitable for elective stapled hemorrhoidectomy

You may not qualify if:

  • Age \< 18 years
  • No informed consent
  • Emergency situation
  • Contraindication to either anaesthesia method
  • Patients not speaking french or german.
  • Additional anal pathology (fissure, tumour).

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of Visceral Surgery, University Hospital Center

Lausanne, 1011, Switzerland

Location

MeSH Terms

Conditions

Hemorrhoids

Interventions

Anesthesia, LocalAnesthesia, General

Condition Hierarchy (Ancestors)

Rectal DiseasesIntestinal DiseasesGastrointestinal DiseasesDigestive System DiseasesVascular DiseasesCardiovascular Diseases

Intervention Hierarchy (Ancestors)

Anesthesia, ConductionAnesthesiaAnesthesia and Analgesia

Study Officials

  • Nicolas Demartines, MD

    Department of Visceral Surgery, University Hospital Center, Lausanne, Switzerland

    STUDY CHAIR
0

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
investigator

Study Record Dates

First Submitted

August 6, 2007

First Posted

August 7, 2007

Study Start

October 1, 2007

Primary Completion

November 1, 2007

Study Completion

May 1, 2008

Last Updated

March 2, 2020

Record last verified: 2020-02

Locations

CH(1)