Comparison of non-mesh (Desarda) and mesh (Lichtenstein) methods for inguinal hernia repair at Mulago Hospital: a single-centre double-blind randomised controlled trial
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Background: Despite the high burden of inguinal hernias in Uganda, and the total embrace of the tension-free mesh techniques in the developed countries, hernia repair in Uganda is still based on the traditional modified Bassini method which is attended by postoperative acute and chronic groin pain and high recurrence index. While the on-lay mesh (Lichtenstein) is considered as a gold standard method of hernia repair, its use has remained low in the developing countries because of its prohibitive cost. The Desarda technique is affordable, simple, and easy to do and learn. It does not require complicated dissection or suturing, and it is not associated with tension on the suture line. There was need to evaluate its effectiveness in Uganda by comparing it with Lichtenstein technique. Since short-term outcomes of hernia repair predict the medium and long term outcomes, they were investigated in this study. Study Objectives: The purpose of the this study was to compare the short-term outcomes of the mesh (Lichtenstein) and non-mesh (Desarda) methods of hernia repair, with regard to acute postoperative pain, day of return to normal gait, operative time and complications. Methods: This was a double-blind randomised controlled study. Participants aged between 18 and 82 with reducible, primary inguinal hernias presenting to the Surgical Out-patient Department (SOPD) of Mulago National Referral Hospital, Uganda were recruited between early April 2009 and July 2009. The participants who met the inclusion criteria were randomly allocated to each of the study arms (Desarda and Lichtenstein). The participants and outcomes assessor were blinded to the treatment method offered. Postoperative acute pain was assessed with the help of a Visual Analogue Scale (V AS) at l-2hrs, 3 days, 7 days and 14ih postoperative day. Gait and Postoperative complications were assessed on the ih and 14th POD. Data entry and analysis were done with Epidata-Entry 3.1 and STATA 10 packages. Analysis was based on the intention-to-treat design. Mean pain score, day of return to normal gait and operative time were compared using a student's t- test. Comparison of complication rates was performed by i (chi¬square) or Fisher's exact test. Bivariate and multivariate analysis using t-test, X 2, analysis of variance (ANOVA) with Bonferroni tests and multiple regression analysis were done to evaluate the influence of baseline factors on the key outcomes. The power of the study was set at 80%, confidence interval at 95% and a two-sided P value of less than 0.05 was considered statistically significant. Results: There were 101 participants of which 13 (12.9%) were females. Fifty one participants were allocated to the Lichtenstein study arm and 50 were allocated to the Desarda arm. Three participants were lost to follow up (two in the Lichtenstein group and one in the Desarda group). The baseline characteristics were similar in the two study arms. There was no significant difference in the mean pain score between the study arms [3rd postoperative day: 3.33±1.75 for Lichtenstein and 2.73±1.64 for Desarda. Effect size (95% CI): 0.59 (-0.088 - 1.272) and the scores on the 7th POD were 1.31±1.19 for Lichtenstein and 1.31±1.34 for Desarda, effect size (95% CI): 0.00 (-0.509 - 0.509)]. No difference was observed in regard to mean day of resumption of normal gait [2.44 ±1.62 for Lichtenstein and 2.06±1.13 for Desarda, effect size (95% CI): 0.08 (-0.030 - 0.193)]. A significant difference was recorded in regard to operative time- with the Desarda repair taking a remarkably shorter duration [15.9 ±3.52 minutes for Lichtenstein repair and 10.02 ±2.93 minutes for Desarda's repair, effect size (95% CI): 5.92 (4.62 -7.20), P=O.OOOI]. Complication rates were similar in the two study arms. Conclusion: This study has shown that efficacy of the Desarda technique III respect of influencing the early clinical outcomes of hernia repair is similar to that of Lichtenstein method. However the operator in this study showed that the Desarda repair takes a significantly shorter operative time. Thus in the face of resource constraints, Desarda's repair should be considered a more cost effective method.