None listed
Conditions
Brief summary
The study designed to test the effect of surgical procedures used on the health and quality of life of the participants, beside their possible side effects or complication, in two different group of patients who were selected and distributed random-ally for the two techniques of surgeries ( open or laparoscopic)
Interventions
This study was done between May 2008 until September 2011, in our university hospital, about 191 cases of unilateral groin hernia, who were fit for general anesthesia and pneumoperitoneum with co2, without complicated hernia, or previous lower abdominal surgery were included. Exclusion criteria also included bilateral and, recurrent hernias. 191 cases were randomly distributed into two groups, using a big container containing 200 balls each ball had a number either one, or, two i.e one hundred ball containing number one, and, another one hundred ball contained number two. After explanation the surgical techniques and the side effects of each technique, and after getting a written consent from the patient to participate in the study, each patient was asked to withdraw one ball with a number, number one means that the patient had undergone laparoscopic transabdominal per-peritoneal mesh repair (TAPP) or group one, and, number two means that the patient belong to the group two or the open Lichtenstein free tension repair. Both procedures were performed under general anesthesia plus a mixtures of 0.5% Bupivacaine, and 1% lidocaine as 1:1 was used to achieve local anesthesia either in inguinal incision or at port site infiltration. Six cases were excluded from laparoscopic group I after surgery, as intra-operative finding of bilateral hernia, and, bilateral repair was done for them, and, they were excluded from the study. TAPP approach with three port sites was performed in 88 unilateral inguinal hernia patients. With sharp dissection, a posterior peritoneal flap was obtained to expose the internal inguinal ring, the sac was dissected and reduced completely if small or partially excised left in situ if large, continued dissection medially exposing the inferior epigastric vessels, the floor of the inguinal canal or the transverses abdominus arch, Cooper’s ligament, and iliopubic tract.7 by 12 cm polypropylene mesh was used to cover the defect and fixed to the transverses abdominus arch, Cooper’s ligament, and iliopubic tract using stables. The peritoneum was closed over the mesh using stables. periumbilical fascial defect was closed with vicryl number 1. The open repair was performed in 97 patients according to the technique, described by Lichtenstein et al., 1989 Lichtenstein, I.L., Schulman, A.G., Amid, P.K.: The tension-free hernioplasty. Am. J. Surg. 159:188, 1989 In both groups skin closure was achieved using subcutaneous monocryl. Follow up of patient early after one month, then every six months or when needed. The definition of chronic pain was depending upon “International Association of the Study of Pain” which defined chronic pain as “pain lasting for 3 months or more,” International Association for the Study of Pain, Subcommittee on Taxonomy. Classification of chronic pain: descriptions of chronic pain syndromes and definitions of pain terms. Pain 1986;3(Suppl): S1–226. The Short-Form 36 (SF-36) was used in the first visit to assess quality of life. SF-36 has three levels: (1) items, (2) eight scales that aggregate, and (3) two summary measures (physical and mental health). The eight scales are well known as: physical functioning which expressed by (10 items), social functioning represented by (2 items), role physical limitations was expressed by (4 items), role limitations due to emotional problems as (3 items), mental health represented with (5 items), vitality had (4 items), bodily pain expressed by (2 items), and general health perception represented by (5 items), each item was represented with a score staring by zero for the worst and 100 for the best. SPSS V 19 was used for data entry. All procedures, patient demographics, and follow-up data were recorded. Results were grouped and statistical significance was determined using the two-sample Wilcoxon rank-sum (Mann-Whitney) test. The primary end point for the study was the total outcomes of the quality of life, the secondary end point was identifications of the complications of both techniques, recurrent rate, and, technical failure. Average time of procedure is between 30-60 minutes Group I or TAPP is the intervention group and Group 2 Lichtenstein free tension repair is the control but active group
Sponsors
Study design
Eligibility
Inclusion criteria
above 18years, diagnosed as inguinal Hernia either direct or indirect, accept to participate 9n the trial, and fit for surgery, had no history of psychological or mental disease
Exclusion criteria
Recurrent, complicated and bilateral cases, unfit for surgery, refusing trial, or had psychological or mental diseases