DOCUMENTACIÓN DE REFERENCIA Manual de Medio ambiente, apartado 4.4.2.

All information and data were entered into a structured form (Appendix 3) constructed for the purpose of this study by the researcher.

The following data were collected pre-orchiectomy

(a) Adequate history was taken which included the bio-data (age, sex, occupation, marital status), presenting complaints, duration of illness/problems, history presenting complaints including LUTS, any history suggestive of expected complications like acute retention, renal failure, haematuria, history suggestive of prostatic malignancy, metastases and history of co-morbid conditions (e.g. diabetes mellitus).

(b) Physical examination findings- general physical examination findings (pallor, icterus, pedal oedema, hepatomegaly, ballotable kidneys etc), anthropometric data (weight, height and body-mass index), digital rectal examination (DRE) findings and clinical stage of prostate cancer (after history and examination) were entered into the structured form.

(c) Samples of venous blood for estimation of the pre-orchiectomy serum testosterone levels and serum PSA level were taken by the researcher himself. The results of the

pre-treatment serum PSA in ng/ml and testosterone levels in nmol/L were entered into the structured form after analysis at the laboratory.

36 (d) The size of the prostate on trans-abdominal pelvic ultrasonography (using 3.5-5 MHz

probe) which was done at the radiology department of LUTH was recorded. Prostate size was calculated using the formula- π/6 × transverse diameter × AP diameter × longitudinal diameter that assumes that the prostate is ellipsoid.⁷¹ Volume was expressed in cm³. (e) The testicular sizes were measured and recorded after a scrotal ultrasound scan (using

7.5MHz probe). Testicular size was also calculated using the ellipsoid formula and volume was expressed in cm³.

(f) The date of prostate biopsy, and histological type of prostate malignancy were recorded in the proforma with the Gleason grades and Gleason score.

(g) Quality of life of the patients was assessed pre-orchiectomy using the FACT-P (version 4) self-administered questionnaire (Appendix 4). Illiterate or incapacitated patients were assisted in filling the quality of life questionnaire by the researcher. Where there was a language barrier, a trained interpreter fluent in the patient’s language was recruited to assist in filling the quality of life questionnaire.

At four weeks and three months post-orchiectomy, the following data were entered (a) Post-orchiectomy serum testosterone and serum PSA levels at these times

(b) In addition, the qualities of life of the patients were assessed at the same time. An item on the FACT-P questionnaire (item P5) used to assess the quality of life measured whether the patient was able to feel like a man at these times.

4.5.1- Procedure for collection of blood samples, storage and analysis of serum samples-

37 Blood samples were collected between 7am to 10am. Blood samples for total serum testosterone and serum total PSA were centrifuged with separation of serum which was stored in cryo-tubes at -80 degrees centigrade at a blood/serum sample storage facility in LUTH. Samples were subsequently analyzed in batches by the same Chemical Pathologists (2 in number) working together assisted by the researcher. Serum total PSA and Testosterone concentrations were quantitatively determined by enzyme immunoassay.

4.5.2- Procedure for bilateral total and subcapsular orchiectomy: Bilateral orchiectomy was done under local anaesthesia (skin infiltration with 2% xylocaine + adrenaline). The spermatic cord was also infiltrated with the local anaesthetic just inferior to the external ring of the inguinal canal. In the theatre, patient was positioned supine and a scrotal median raphe incision was made through skin, dartos, and layers of the scrotum and tunica vaginalis to expose the testis and the spermatic cord on one side first.

For total orchiectomy, the spermatic cord was split into two or three pedicles through avascular planes with excision of the testis and distal spermatic cord. The remaining pedicles were transfixed using vicryl 2 sutures.

For subcapsular orchiectomy, a longitudinal incision was made through the tunica albuginea of the testis along its free border, exposing the yellowish inner parenchymal tissue (composed mainly of Leydig cells and seminiferous tubules). The testicular parenchymal tissue was bluntly dissected from the inner wall of the tunica albuginea. The dissected parenchyma was divided at the testicular hilum using scissors. Any tissue remaining on the inside of the tunica albuginea was removed and meticulous haemostasis was achieved using diathermy. The capsule was re-sutured with a continuous layer of 3-0 vicryl.

38 The procedure (total or subcapsular orchiectomy) was repeated on the other side through the same skin incision and the wound closed using 3-0 vicryl to layers of the scrotal wall, and 2-0 vicryl to the scrotal skin. The procedure was completed by local dressing, a large gauze pressure pad and a scrotal support.

4.5.3- Scoring system for the FACT-P questionnaire- The Functional Assessment of Chronic Illness Therapy (FACIT) measurement system questionnaires are designed for patient

self-administration, but can also be administered by interview format. Both methods were used in this study. The FACT-P (Appendix 4) has five individually scored subscales that evaluate the

patient’s physical well-being (PWB), social/family well-being (SWB), emotional well-being (EWB), functional well-being (FWB) and additional concerns (PCS) that relate directly to prostate cancer. The first four subscales previously mentioned make up the FACT-G

questionnaire used to assess the general quality of life of the patient. Addition of the last scale (additional concerns) makes it a FACT-P questionnaire. Summation of the individual subscale scores produced a total FACT-P score of which scores can range from ‘0’ to ‘156’- the higher the score, the better the quality of life. Individual item, subscale and FACT-G scores can also be calculated and compared amongst patients.

Item P5 on the questionnaire helped to assess the effect of the type of orchiectomy on body image and perception of self as a man.

Complete details of the scoring guidelines are also provided in appendix 4 after the main FACT-P questionnaire.