Condition category
Circulatory System
Date applied
19/01/2010
Date assigned
01/02/2010
Last edited
01/02/2010
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Dr Wolfgang Mouton

ORCID ID

Contact details

Krankenhausstrasse 12
Thun
3600
Switzerland

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

N/A

Study information

Scientific title

Surgery as a trigger for neorevascularisation in recurrent saphenofemoral incompetence: a randomised trial of three different techniques

Acronym

Study hypothesis

Surgery itself, and maybe the type of surgery, may trigger neorevascularistion in the groin when treating sapheno-femoral incompetence.The hypothesis is that one of the following three techniques is better - inducing less neorevascularisation - than the other two. If this would be the case this one technique should be preferred to the other two, worldwide.

The three techniques are:
1. Dissection under ligation
2. Dissection with electrocoagulation
3. Ultrasonic dissection

Ethics approval

Ethics Commission of the Regionalspital Thun approved on the 1st March 2002 (ref: 2:4;1.3)

Study design

Prospective randomised study

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Hospitals

Trial type

Prevention

Patient information sheet

Not available in web format, please use the contact details below to request a patient information sheet

Condition

Recurrent varicose veins

Intervention

The study was approved by the local Human Ethics Committee. All patients included in the study have informed pre-operative consent. 36 consecutive unselected patients underwent redo saphenous high ligation procedures during a period of thirteen months (1st April 2002 - 30th June 2003).

The study population comprised 34 female patients and 2 males. The age ranged from 24 to 73 years (mean 53 years). Thirty-two patients had undergone at least one previous procedure in the groin. The patients were randomised to receive either dissection with ultrasound (Ultracision Harmonic Scalpel, Ethicon Endo-Surgery, Johnson and Johnson Company, Spreitenbach, Switzerland) or electrocoagulation (Elektrotom Berchtold GmbH&Co, Tuttlingen, Germany) or sharp dissection with ligation of scar and lymphatic tissue using absorbable suture material (Vicryl, Ethicon Endo-Surgery, Johnson and Johnson Company, Spreitenbach, Switzerland).

The groin was reopened via a transverse incision. The femoral artery was visualised as a landmark, after which the femoral vein was dissected and recurrent veins ligated and divided. Fascia and subcutaneous tissue was closed in two layers and included a vacuum wound drain. The skin was closed with sutures. Operating time is around one hour per procedure. The drain was removed one day post-operatively.

After three months a clinical and colour duplex ultrasonography investigation (Acuson Aspen, Acuson Corporation, Mountain View CA, USA) were carried out to detect lymphatic complications. After seven years a clinical and colour duplex ultrasonography investigation were carried out to detect and describe type and extent of neorevascularisation for the patients of all three treatment arms.

Intervention type

Other

Phase

Not Applicable

Drug names

Primary outcome measures

Clinical outcome and duplex sonography outcome at three months
VDS: venous disability score
VCSS: venous clinical severity score

Secondary outcome measures

Clinical outcome and duplex sonography outcome at seven years
VDS: venous disability score
VCSS: venous clinical severity score

Overall trial start date

01/04/2002

Overall trial end date

01/06/2010

Reason abandoned

Eligibility

Participant inclusion criteria

1. Consecutive randomised patients with re-do surgery for sapheno-femoral incompetence in the groin
2. Written informed consent
3. Adults greater than 16 years old, either sex

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

36

Participant exclusion criteria

Does not want to take part in the study

Recruitment start date

01/04/2002

Recruitment end date

01/06/2010

Locations

Countries of recruitment

Switzerland

Trial participating centre

Krankenhausstrasse 12
Thun
3600
Switzerland

Sponsor information

Organisation

Regionalspital Thun (Switzerland)

Sponsor details

Krankenhausstrasse 12
Thun
3600
Switzerland

Sponsor type

Hospital/treatment centre

Website

Funders

Funder type

Hospital/treatment centre

Funder name

Regionalspital Thun (Switzerland) - paying incidental costs

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes