Condition category
Digestive System
Date applied
31/12/2018
Date assigned
10/06/2019
Last edited
26/04/2019
Prospective/Retrospective
Retrospectively registered
Overall trial status
Ongoing
Recruitment status
Recruiting

Plain English Summary

Background and study aims
Over 200 million people live with a groin hernia worldwide and if left untreated, this condition causes considerable pain and also leads to 40,000 deaths per year. Epidemiological studies among women have not been performed to determine the real burden of disease but a previous study in Eastern Uganda indicated groin hernias in women contributing 24% of groin hernia surgery volume. A facility based study carried out in 29 hospitals in Uganda found that 16% of the groin hernia repairs were performed in women, mainly using tension techniques (manuscript). Tension groin hernia repairs have high rates of recurrence compared to mesh repair.

Groin hernia repair is the commonest general surgical procedure performed globally (8). It affects children, women and men but most research has been carried out in men. The risk of recurrence is higher in women than in men when the same methods are used (11). In the emergency setting, mortality is higher for women than for men undergoing hernia repair (13). This inequity warrants further investigation and correction.

Laparoscopic approach is considered the gold standard in mesh hernia repair in women (14). This method is not available to the majority of the patients in sub-Saharan Africa or Uganda. An open method for repair of groin hernia in women, which is easy to learn, safe to use and with high cost-effectiveness is therefore called for.

The proposed study will investigate the use of a modified anterior mesh technique, that will cater for both inguinal and femoral hernias, hoping that we can reduce recurrence and chronic groin pain after groin hernia repair in women.

The aims of this study are:
1. Evaluate and compare the outcomes after hernia repair using the anterior mesh repair and the modified version of the anterior mesh repair in adult females.
2. Calculate (and compare) costs and cost-effectiveness of this procedure (of the modified anterior mesh repair against the Lichtenstein method.

Who can participate?
Adult women without significant comorbidities (ASA class 1 and 2) with primary, reducible groin hernia.

What does the study involve?
Study participants will be randomised to being operated using an anterior mesh repair or a modified anterior mesh repair for their groin hernia. The surgery will be done under local anaesthesia as day case surgery. Prior to inclusion into the study, patients will be physically examined including ultrasonography of the groins.

What are the possible benefits and risks of participating?
Surgery is always associated with certain risks. The risk of elective groin hernia repair is however small. The patients will be operated on by consultant surgeons which is rare in Uganda. The patients will also be followed up after 2 weeks, one and three years. No costs are associated with the surgeries for the study participants.

Where is the study run from?
The study will be carried out in several hospitals in Uganda. There are 11 tentative hospitals but the number who will actually contribute to the study will depend on how well recruitment and inclusion of patients into the study goes.

When is the study starting and how long is it expected to run for?
Inclusion of patients into the study will begin in October 2019. We expect the recruitment to be completed during 2020. Follow up will be done between 2020 and 2023.

Who is funding the study?
The study is funded through grants from the Swedish Medical Society and the Swedish Research Council.

Who is the main contact?
Jenny Löfgren, jenny.lofgren@ki.se
Alphonsus Matovu, senior consultant surgeon at Mubende Regional Referral Hospital and PhD student at Karolinska Institutet. Leading study activities on site.
E-mail: alphonsusing@gmail.com

Trial website

Contact information

Type

Public

Primary contact

Dr Jenny Löfgren

ORCID ID

http://orcid.org/0000-0001-5884-0369

Contact details

Department of Molecular Medicine and Surgery
Karolinska Institutet
Karolinska University Hospital
Solna (L1:00)
Stockholm
17176
Sweden
0704 612426
jenny.lofgren@ki.se

Type

Scientific

Additional contact

Dr Jenny Löfgren

ORCID ID

http://orcid.org/0000-0001-5884-0369

Contact details

Department of Molecular Medicine and Surgery
Karolinska Institutet
Karolinska University Hospital
Solna (L1:00)
Stockholm
17176
Sweden
0704 612426
jenny.lofgren@ki.se

Additional identifiers

EudraCT number

Nil known

ClinicalTrials.gov number

Nil known

Protocol/serial number

N/A

Study information

Scientific title

Open anterior mesh repair versus modified open anterior mesh repair for groin hernia in women. A double blinded randomized controlled trial.

Acronym

FemRep

Study hypothesis

There will be no clinically or statistically significant differences in terms of the primary and secondary endpoints when comparing the two surgical methods under study.

Ethics approval

Mildmay Uganda - Research Ethics Committee, 20/12/2018, ref. 0110-2018.

Study design

Interventional, multi-centre, double blind, randomised controlled trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Hospitals

Trial type

Treatment

Patient information sheet

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

Condition

Groin hernia

Intervention

All patients will be physically examined, including ultrasonography of the groin, for diagnosis. All patients will be operated for their groin hernia. Two techniques will be used. The duration of the surgery will be 1-2 hours in most cases, depending on the level of complexity. All patients will be followed up after 2 weeks, 1 year and 3 years. Patients will be randomised to the control or experimental group after diagnosis has been assured. A computer-based program will be used and the randomisation will be done by a nurse. If a patient randomised to the control arm is found to have a femoral hernia (intraoperatively) she will cross over to the experimental arm).

Control arm: Anterior mesh repair according to Lichtenstein, under local anaesthesia.

Experimental arm: Modified anterior mesh repair under local anaesthesia. All steps are the same as for the control arm but in addition, the transversals fascia is opened and a slit of the mesh is fixed to cover the femoral canal.

Intervention type

Procedure/Surgery

Phase

Drug names

Primary outcome measure

Recurrence will be determined by a blinded observer through physical examination at 1 and 3 years. In unclear cases, ultrasonography will be used in addition to the physical examination.

Secondary outcome measures

1. Postoperative complications will be determined through physical examination by a blinded observer at 2 weeks.
2. Self-Assessed health status will be measured using a health thermometer where 0 represents the worst imaginable health, and 100 represents the best imaginable health. This is done preoperatively, at 2 weeks, 1 year and 3 years.
3. Patient satisfaction will be measured through asking the study participants "are you satisfied with the result of the operation?" as well as "are your level of groin symptoms less, the same or worse compared to before the surgery?". This is done at 1 and 3 years.
4. Cost and cost-effectiveness of the interventions will be calculated in terms of cost in USD per DALY averted. The IPQ results will be translated into disability weights for DALY calculation. Costs will be assessed from the providers perspective, including information on materials and medicines, staff costs, capital costs and overhead costs.
5. Chronic pain will be measured using the Inguinal Pain Questionnaire. Level of pain will be assessed before the operation, and at 1 and 3 years postoperatively

Overall trial start date

01/01/2017

Overall trial end date

01/02/2024

Reason abandoned (if study stopped)

Eligibility

Participant inclusion criteria

1. Female
2. Primary, reducible groin hernia
3. ASA class 1-2

Participant type

Patient

Age group

Adult

Gender

Female

Target number of participants

440 + 50

Participant exclusion criteria

1. Recurrent hernia
2. Alcohol or substance abuse
3. Known or suspected coagulopathy.

Recruitment start date

01/02/2019

Recruitment end date

01/02/2021

Locations

Countries of recruitment

Uganda

Trial participating centre

Arua Regional Referral Hospital
Arua
Arua
N/A
Uganda

Trial participating centre

Mubende Regional Referral Hospital
Mubende
Mubende
N/A
Uganda

Trial participating centre

Hoima Regional Referral Hospital
Hoima
Hoima
N/A
Uganda

Trial participating centre

Jinja Regional Referral Hospital
Jinja
Jinja
N/A
Uganda

Trial participating centre

Iganga General Hospital
Iganga
Iganga
N/A
Uganda

Trial participating centre

Buluba Mission Hospital
Buluba
Jinja
N/A
Uganda

Trial participating centre

Kitovu Mission Hospital
Masaka
Masaka
N/A
Uganda

Trial participating centre

Tororo General Hospital
Tororo
Tororo
N/A
Uganda

Trial participating centre

Kitgum General Hospital
Kitgum
Kitgum
N/A
Uganda

Trial participating centre

Lacor Mission Hospital
Gulu
Gulu
N/A
Uganda

Trial participating centre

Kamuli Mission Hospital
Kamuli
Kamuli
N/A
Uganda

Sponsor information

Organisation

Karolinska Institutet

Sponsor details

Department of Molecular Medicine and Surgery
Karolinska Institutet
Karolinska University Hospital
Solna (L1:00)
Stockholm
17176
Sweden

Sponsor type

University/education

Website

www.ki.se

Funders

Funder type

Government

Funder name

Vetenskapsrådet

Alternative name(s)

Swedish Research Council, VR

Funding Body Type

government organisation

Funding Body Subtype

National government

Location

Sweden

Funder name

Swedish Medical Society

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Study findings will be published after the one year and the three year follow up. Cost and cost effectiveness analysis will be published separately from the clinical findings.

IPD sharing statement: the datasets generated during and/or analysed during the current study will be available upon request from Dr Jenny Löfgren (jenny.lofgren@ki.se). The data available will be raw data (original or scanned forms or in excel format) and it will be available from the time of publication based on the one year follow up. Raw data will be stored for 10 years. We do not expect to share data for research purposes but it will be made available by request from reviewers or the journals where we submit the manuscripts. Sharing of data is not part of the patient consent.

Intention to publish date

01/06/2021

Participant level data

Available on request

Basic results (scientific)

Publication list

Publication citations

Additional files

Editorial Notes