Condition category
Surgery
Date applied
09/10/2003
Date assigned
23/10/2003
Last edited
10/10/2014
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 David Sokal

ORCID ID

Contact details

Family Health International
PO Box 13950
Research Triangle Park
North Carolina
27709
United States of America
+1 919 405 1466
dsokal@fhi.org

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

Study # 9638

Study information

Scientific title

Acronym

Study hypothesis

Not provided at time of registration

Ethics approval

Not provided at time of registration

Study design

Randomised controlled trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Hospitals

Trial type

Treatment

Patient information sheet

Condition

Vasectomy

Intervention

No-scalpel vasectomy by ligation and excision, with fascial interposition versus without fascial interposition

Intervention type

Procedure/Surgery

Phase

Not Applicable

Drug names

Primary outcome measures

Not provided at time of registration

Secondary outcome measures

Not provided at time of registration

Overall trial start date

01/12/1999

Overall trial end date

01/06/2002

Reason abandoned

Eligibility

Participant inclusion criteria

Men seeking a vasectomy

Participant type

Patient

Age group

Adult

Gender

Male

Target number of participants

841

Participant exclusion criteria

Not provided at time of registration

Recruitment start date

01/12/1999

Recruitment end date

01/06/2002

Locations

Countries of recruitment

Brazil, El Salvador, Mexico, Nepal, Panama, Sri Lanka, United States of America

Trial participating centre

Family Health International
North Carolina
27709
United States of America

Sponsor information

Organisation

Family Health International (USA)

Sponsor details

PO Box 13950
Research Triangle Park
North Carolina
27709
United States of America
+1 919 544 6979
dgrimes@fhi.org

Sponsor type

Research organisation

Website

http://www.fhi.org/en/index.htm

Funders

Funder type

Government

Funder name

Family Health International (USA) - partial support

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Funder name

U.S. Agency for International Development (USAID) Cooperative Agreement( (ref: CCP-A-00-95-00022-02) - funding

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Funder name

EngenderHealth (USA) with funds from USAID Cooperative Agreement (ref: HRN-A-00-98-00042-00) - funding

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

2004 results in: http://www.ncbi.nlm.nih.gov/pubmed/15056388

Publication citations

  1. Results

    Sokal D, Irsula B, Hays M, Chen-Mok M, Barone MA, , Vasectomy by ligation and excision, with or without fascial interposition: a randomized controlled trial [ISRCTN77781689]., BMC Med, 2004, 2, 6, doi: 10.1186/1741-7015-2-6.

Additional files

Editorial Notes