Trial document





This trial has been registered retrospectively.
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  DRKS00017536

Trial Description

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Title

Quality of Life of female working age patients after operative therapy of a groin Hernia

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Trial Acronym

QuaLiHern

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URL of the Trial

[---]*

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Brief Summary in Lay Language

90% of surgical procedures on groin hernias are performed on men. Accordingly, there are relatively few studies that refer primarily to women with groin hernias.
Nevertheless, research shows that women with groin hernias generally experience a more complicated course with more frequent recurrence of the hernia and more complications, such as chronic pain. These factors can have a negative impact on patients' physical performance and quality of life and especially younger patients are affected.

Therefore, we want to assess the quality of life and hip mobility of working age (younger than 67 years at date of surgery) women after hernia surgery and compare these results with the quality of life and hip mobility of
a) working age men after groin hernia surgery and
b) working age women without prior groin surgery.

Patients who can be assigned to one of these groups are interviewed and examined during a visit to our hospital.

During the visit, the participants are asked to complete three different questionnaires on quality of life. In addition, the strength and mobility of the hip joint will be examined in a physical examination.

We assume that the female patients operated on the groin
1) experience a reduced quality of life
2) more frequent and more severe inguinal pain
3) are less articulated in the hip and can apply less force.
To verify these assumptions, we will conduct this study.

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Brief Summary in Scientific Language

Women with groin hernias experience more peri- and postoperative adverse events than male patients. This is especially true for younger, possibly employed, women. Nevertheless, the influence of groin hernia surgery on the quality of life and physical performance of this group is not investigated sufficiently. In this monocentric cohort study, we want to examine this with the help of three quality of life specific questionnaires and a physical examination of the hip with an emphasis on mobility and strength.

Since June 2014, surgically treated patients with hernia at University Clinic for Visceral Surgery at Pius Hospital are enrolled for the German hernia register herniamed after informed consent. They also agree that they can be contacted by the clinic for further questioning and examination.

A total of three groups of patients will be examined, two of whom will be recruited from herniamed.
Group 1 shall be recruited from patients of the described cohort of registered hernia patients. The decisive criterion is that the operation took place before the patient reached the age of 67 and that the patients have completed at least the age of 18 at time of operation. Exclusion criteria are insufficient knowledge of German, refusal to participate in the examination, neurological deficits of the lower extremity, a hip prosthesis on the body side treated for hernia, and previous death of the patient. Patients who meet the inclusion criteria will be contacted by telephone. The exclusion criteria are queried and an appointment is made for presentation at the clinic.

Group 2 consists of male patients of the herniamed cohort who are paired with the patients according to various criteria. Matching criteria are a) date of surgery (+/- 3 months) b) patient's age (+/- 2 years) c) hernia classification determined during surgery d) BMI at date of surgery, divided into the four groups corresponding to the WHO categories underweight (BMI < 18.5 kg/m2), normal weight (BMI from 18.5 to < 25.0 kg/m2), overweight (BMI from 25.0 to < 30 kg/m2) and obesity (BMI from 30 kg/m2) e) surgical method (open or laparoscopic) f) classification as primary or recurrent hernia. Exclusion criteria and the process of inclusion are the same as for group 1.

Group 3 should consist of elective in-patients of the clinic that are not operated on the groin or abdomen. They will be informed about the study upon admission, asked for consent to participate and will be examined on the first postoperative day and asked to complete the questionnaires. The only inclusion criterion is an age between 18 and 67 years. The exclusion criteria correspond to those of groups 1 and 2. In addition, no abdominal, hip or pelvic surgery should have been performed in the past year.

Patients will receive three questionnaires to determine their quality of life (Short Form (36) Health Questionnaire (SF-36), Core Outcome Measures Index for Hernias (COMI), Carolinas Comfort Scale (CCS)) as part of a clinical visit and will be examined with goniometer and hand dynamo for strength and mobility in the hip.

The three groups each form two samples (group 1 & group 2, and group 1 & group 3) which are to be compared against each other.
The primary questions are the following:
1. is the quality of life of operated working age women with groin hernias (group 1) different from the quality of life of operated working age men with groin hernias (group 2) or from that of a female control group (group 3), as measured by CCS, COMI and SF-36 questionnaires?
2. are there significant differences in hip mobility and strength between groups 1 & 2 and 1 & 3?
The secondary aim is to investigate whether the German versions of the CCS and COMI questionnaires also provide valid and reliable results in a female cohort.

The hypotheses regarding the investigated aspects are the following:
1. female patients who have undergone groin hernia surgery experience a reduced quality of life compared to men who have undergone surgery and women who have not undergone groin hernia surgery.
2. female patients after groin hernia surgery report significantly more pain in the operated groin than men. It is also significantly more severe.
3. female patients after groin hernia surgery have limited hip strength and mobility.

Scheduling:
1. Basic information on patients and operations has been collected since June 2014 as part of the herniamed examination in the Pius Hospital.
2. in July 2019, patients who fit the inclusion criteria for groups 1 and 2 will be contacted.
3. from July 2019 to the end of January 2020, the patients are to be presented to complete the questionnaires and clinical examination. During the same period the patients of group 3 will be recruited and examined.
4. February 2020: statistical analysis

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Do you plan to share individual participant data with other researchers?

Yes

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Description IPD sharing plan:

All anonymised data including study protocol and statistical evaluations can be requested from the study director Dr Uslar.

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Organizational Data

  •   DRKS00017536
  •   2020/01/15
  •   [---]*
  •   yes
  •   Approved
  •   2019-069, Medizinische Ethikkommission der Carl von Ossietzky Universität Oldenburg
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Secondary IDs

  • [---]*
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Health Condition or Problem studied

  •   K40 -  Inguinal hernia
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Interventions/Observational Groups

  •   Quality of life and hip performance in female patients after surgical treatment of groin hernia between 18 and 67 years of age.
  •   Quality of life and hip performance in male patients after surgical treatment of groin hernia between 18 and 67 years of age.
  •   Quality of life and hip performance in women aged 18 to 67 years without surgery in the groin and abdominal region within the previous year.
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Characteristics

  •   Non-interventional
  •   Observational study
  •   Non-randomized controlled trial
  •   Open (masking not used)
  •   [---]*
  •   Other
  •   Prognosis
  •   Other
  •   N/A
  •   N/A
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Primary Outcome

Quality of life of female patients after herniotomy, determined from results of the SF-36, COMI and CCS questionnaires (Core Outcome Measures Index for Hernias (COMI), Carolinas Comfort Scale (CCS))
and
Performance in the hip joint of female patients after herniotomy, determined as mobility in degrees (abduction, external and internal rotation, flexion and extension) and force (in the respective direction of movement). Patients are invited to one study visit to the surgical clinic between September 2019 and January 2020.

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Secondary Outcome

The secondary aim is to investigate whether the German versions of the CCS and COMI questionnaires also provide valid and reliable results in a female cohort.

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Countries of Recruitment

  •   Germany
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Locations of Recruitment

  • Medical Center 
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Recruitment

  •   Actual
  •   2019/07/01
  •   100
  •   Monocenter trial
  •   National
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Inclusion Criteria

  •   Both, male and female
  •   18   Years
  •   73   Years
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Additional Inclusion Criteria

Group 1:
- female patients of the clinic who have signed a consent to be included in the herniamed registry and to be contacted
- surgery after completion of the 18th and before completion of the 67th year of life

Group 2:
- male patients of the clinic who have signed a consent to be admitted to the herniamed registry and to be contacted
- matching with patients of group 1 according to
a) date of surgery (+/- 3 months)
b) age (+/- 2 years)
c) hernia classification established during surgery
d) BMI at surgery divided into four groups corresponding to WHO categories: Underweight (BMI < 18.5 kg/m2), Normal (BMI from 18.5 to < 25.0 kg/m2), Overweight (BMI from 25.0 to < 30 kg/m2) and Obessive (BMI from 30 kg/m2)
e) surgical method used (open or laparoscopic)
f) classification as a primary or recurrent hernia

Group 3:
- female patients who are elective inpatients in treatment at the clinic
- are not operated on the groin or abdomen
- age between 18 and 67 years

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Exclusion Criteria

- insufficient German language skills
- refusal to participate in the investigation
- neurological deficits of the lower extremity
- hip prosthesis on the body side treated for a hernia
- previous death of the patient

group 3 additionally: no surgery on abdomen, hips and pelvis in the previous year

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Addresses

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    • Universitätsklinik für Viszeralchirurgie, Klinik für Allgemein- und Viszeralchirurgie, Pius-Hospital Oldenburg
    • Mr.  Prof. Dr. med.  Dirk  Weyhe 
    • Georgstraße 12
    • 26121  Oldenburg
    • Germany
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    • Universitätsklinik für Viszeralchirurgie, Klinik für Allgemein- und Viszeralchirurgie, Pius-Hospital Oldenburg
    • Ms.  Dr.  Verena  Uslar 
    • Georgstraße 12
    • 26122  Oldenburg
    • Germany
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    • Universitätsklinik für Viszeralchirurgie, Klinik für Allgemein- und Viszeralchirurgie, Pius-Hospital Oldenburg
    • Ms.  Dr.  Verena  Uslar 
    • Georgstraße 12
    • 26122  Oldenburg
    • Germany
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Sources of Monetary or Material Support

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    • Universitätsklinik für Viszeralchirurgie, Klinik für Allgemein- und Viszeralchirurgie, Pius-Hospital Oldenburg
    • Mr.  Prof. Dr. med.  Dirk  Weyhe 
    • Georgstraße 12
    • 26122  Oldenburg
    • Germany
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Status

  •   Recruiting ongoing
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Trial Publications, Results and other Documents

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* This entry means the parameter is not applicable or has not been set.