Comparing the Quality of Life After Nylon Darn Repair of Inguinal Hernia to Polypropylene Mesh Repair
Comparing the Quality of Life After Nylon Darn Repair of Inguinal Hernia to Polypropylene Mesh Repair
Inguinal hernia repair may be done by the nylon darn, polypropylene mesh and other methods.
 Polypropylene mesh is established in the literature as the standard of care for inguinal
 hernia repair. It is however expensive and not readily available in our community hospitals.
 Nylon darn repair is widely used in our hospitals. We think that the quality of life
 following nylon darn repair and polypropylene mesh repair is similar. In order to find out,
 we are recruiting 79 patients to undergo nylon darn repair for their inguinal hernia and
 another 79 patients to undergo polypropylene mesh repair for their inguinal hernia repair.

 We are doing research to compare the quality of life after nylon darn repair of inguinal
 hernia to polypropylene mesh repair in patients aged 18 years to 80 years who come to St.
 Luke Hospital for their first-ever inguinal hernia repair.
This will be a randomised controlled trial of patients undergoing polypropylene mesh and
 nylon darn repair for inguinal hernias at St. Luke Hospital, Kasei, Ghana.

 The study will be conducted at the St. Luke Hospital, Kasei, Ghana. St. Luke Hospital is a
 primary hospital facility situated in the Ejura-Sekyedumase district of Ghana.

 The surgical unit of the hospital has 58 beds and offers specialist surgical services through
 the outpatient's clinic, 24-hour emergency unit and the operating theatre.

 Elective groin hernia repairs are performed daily by the surgical team comprising specialist
 surgeon, medical officers, anaesthetists and perioperative nurses. Both nylon darn technique
 and mesh repairs are performed.

 SAMPLE SIZE:

 Mommers et al., in their use of COMI-hernia tool to assess patient quality of life following
 120 hernia repairs, reported a mean score of QoL at 6 weeks postop of 1.6 (SD ± 1.5) and a
 mean VAS pain score at 6 weeks postop of 1.0 (SD ± 1.7).

 Assuming this score and using the sample size formula for non-inferiority clinical trials
 (two-sample parallel trial)

 n=(〖2(zα+zβ)〗^2.σ^2)/(ϵ-δ)^2

 Where:

 n=Sample size Zα= 1.64, corresponding to one-tailed significance level for α =0.05 Zβ=0.84,
 corresponding to power of 80% σ = Standard Deviation ε = 0% (ie. = 0.00), true difference in
 mean between the treatment and active control [μ2(test) - μ1(control)] δ = non-inferiority
 margin of 50%

 -  (2(1.64+0.84)^2.〖(1.7)〗^2)/(-0.00-(-0.50))^2

 -  (2(2.48)^2 〖(1.7)〗^2)/(-0.00-(-0.50))^2 =2x6.1504x2.89/((0.25) ) =142.2 Providing for
 10% attrition at the patient level, we arrive at a sample size of 158.

 A hundred and twenty-two patients (79 for each arm), who fulfil the inclusion criteria, will
 be recruited for the study.

 Consecutive patients presenting with an inguinal hernia who fulfil the inclusion criteria
 will be approached for recruitment into the study. The study and its objectives will be
 clearly explained to the prospective participant as per the patient information leaflet. The
 patient will then be given the opportunity to ask questions. Prospective participants will be
 assured that they are not under obligation to participate in this study. They may change
 their mind later and stop participating even if they agreed earlier. If they choose not to
 participate, they will receive the established standard treatment offered at St. Luke
 Hospital for patients presenting with inguinal hernia.

 If a patient consents to participate in the study, that participant will then sign or
 thumbprint the written consent form. If a prospective participant is non-literate, the
 participant information leaflet will be interpreted to the participant in his/her local
 language, in the presence of a literate witness. The literate witness will countersign the
 written informed consent form. A copy of the consent form will be kept in the investigator's
 records. Another copy will be given to the patient in addition to the patient information
 leaflet.

 Randomisation will be done using a computer-generated sequential schedule in blocks of six
 (6) with an allocation ratio of 1:1. The generated schedule will be sealed in serially
 numbered opaque envelopes to be placed in a container at the operating theatre. Theatre staff
 will be chosen to pick the envelopes and allocate participants to either group during the
 surgery. This will only be done after the surgeon has performed high ligation of the sac for
 indirect hernias or reduction of the contents of the sac for direct hernias. The next
 serially numbered envelope will be opened for each new participant. The sequence will be
 generated by an independent statistician who will not be involved in the enrolment,
 management/treatment or assignment of participants. Trial participants will not be informed
 of their assignment, but this will be known by the operating surgeons.

 A participant can withdraw from the study at any point of the study without having to explain
 the decision. In the event of a participant withdrawing from the study, the established
 standard treatment offered to patients presenting with inguinal hernia at St. Luke Hospital
 will be continued. A trial exit form will be completed by the principal investigator for that
 participant.

 The participant and the trained research assistant will be blinded to the intervention used
 for the participants.

 One hundred and fifty-eight patients (18 years and above) presenting for inguinal hernia
 repair at the surgical theatre of St. Luke Hospital within the study period of one year will
 be approached and screened to determine their eligibility to participate in the study.

 After obtaining consent, initial data including socio-demographics of the patient, history
 and clinical examination to characterize the inguinal hernia, will be extracted from the
 patient's folder and recorded on the data gathering form.

 The patient's identity will be protected by using coded identifiers. Data gathering will be
 done under the strict supervision of the project supervisor.

 Patient pre-operative data will also be collected according to the structured data gathering
 form.

 This will include the grade of the inguinal hernia based on Kingsnorth's classification of
 inguinal hernia The ASA (American Society of Anaesthesiologists) score as recorded by the
 qualified anaesthetist during the anaesthetic assessment will be recorded

 Patients will be operated as day cases as practiced in the hospital. If for any reason a
 patient has to stay overnight, they will be included in the study and the reason for
 overnight stay noted.

 During the surgery, the operating surgeon will be informed about which arm the patient has
 been randomized into after the skin incision has been made and the surgeon has performed high
 ligation of the sac for indirect hernias or reduction of the contents of the sac for direct
 hernias.

 Group 1: Patients to undergo inguinal hernia repair using nylon darn technique Group 2:
 Patients to undergo inguinal hernia repair using polypropylene mesh. The inguinal hernia
 repair will be performed using anaesthesia as determined by a qualified anaesthetist during
 the anaesthetic assessment.

 Inguinal hernia repair by either technique will be carried out by a specialist surgeon or a
 trained medical officer.

 Patients will be discharged home on a five (5) day supply of oral diclofenac sodium to be
 taken 12 hourly after meals for pain control.

 A dedicated phone number (of the primary investigator) will be provided for patients to call
 in case they have any concerns.

 Wound dressings will be changed by a qualified nurse in the hospital's wound dressing room.
 This will be done on alternate days, starting on postoperative day 3 for patients in both
 arms of the study. At each wound dressing, the investigator will assess for haematoma,
 seroma, testicular swelling and wound infection. If any wound problems are diagnosed, this
 will be recorded on the case report form and the patient managed appropriately.

 If no wound problems are found, all stitches will be removed on the seventh postoperative day
 at the surgical outpatients' clinic.

 Participants will be contacted 12 weeks after surgery to come for a clinical review at the
 general surgery outpatients' clinic. If for any reason the participant cannot come for the
 12th-week clinical review, a follow-up visit to the participant in his community will be
 done. If this is not successful, a follow-up phone call will be placed and the follow-up
 interview administered.

 In case the participant actively withdraws consent, dies anytime between the allocation and
 the 12th-week follow-up or patient could not be reached for the 12th-week follow-up
 interview, a trial exit form will be completed for that participant.

 Data collection will be done by the primary investigator and the trained research assistant
 into the structured data entry form, including the COMI-Hernia tool. For each patient, the
 COMI-hernia total score before surgery and 12 weeks after surgery will be calculated.

 Participant's identity will be protected by using coded identifiers. Data will be transcribed
 into electronic form using Microsoft® Access® 2010 (Microsoft Corporation, Redmond,
 Washington). Data cleaning will be done weekly to ensure consistency.

 Data will be coded and analysed using STATA v.14 software (StataCorp LLC, College Station,
 Texas). Data will be presented using descriptive statistics. Measures of central tendency and
 dispersion will be used to describe quantitative variables such as the COMI-hernia score
 (mean ± standard deviations (SD) for normally distributed data and median and ranges for
 skewed data). Categorical variables will be expressed as numbers and percentages. Differences
 between mean COMI-Hernia total scores of patients undergoing nylon darn repair and
 polypropylene mesh repair will be determined with the Student's t-test. One-way analysis of
 variance (ANOVA) with post-hoc analysis will be used to confirm significance between the
 groups if the data is normally distributed. For skewed data, Kruskal Wallis analysis will be
 used. Chi square goodness of fit will be used to test association between variables. Relative
 risk [95% confidence interval (CI)]. Statistical significance will be set at p< 0.05.
Inclusion Criteria:

 -  Patients, 18 years and above, presenting with primary reducible inguinal hernias

 -  Patients, 18 years and above, with irreducible inguinal hernias which is neither
 obstructed nor strangulated.

 Exclusion Criteria:

 -  Patients who do not consent to participate in the study.

 -  Patients presenting with recurrent, obstructed or strangulated hernias

 -  Patients with bilateral hernias

 -  Patients with immunosuppression (uncontrolled diabetes mellitus, malnutrition,
 patients on long-term steroids, known AIDS patients)

 -  Patients with chronic debilitating illnesses (chronic renal or liver failure,
 congestive cardiac failure) and urinary bladder outlet obstruction

 -  Concomitant repair of another abdominal hernia e.g. umbilical hernia

 -  Hernia repair combined with another surgical procedure

 -  Patients under the age of 18 years and over 80 years

 -  Pregnant women

 -  ASA score 4 or more