Naveen 2014.
Methods | 70 participants admitted in the surgical wards of Sri Adichunchanagiri Hospital and Research Center, BG Nagara, India, and diagnosed to have an inguinal hernia, were included in the study. They were randomly allocated to undergo a Modified Bassini's repair (MBR) (35) or a Lichtenstein Mesh Repair (LMR) (35). | |
Participants | Any patient with an inguinal hernia (irrespective of type, direct and indirect) admitted at the time of enrolment was included apart from the following exclusion criteria: congential inguinal hernia, pregnant women, participants with recurrent/bilateral/complicated inguinal hernia and participants with coagulopathy or on anticoagulant therapy. | |
Interventions | A classical incision was used for all participants; 2.5cm above and parallel to the medial three‐fifths of the inguinal ligament. Then participants underwent either of the following. Modified Bassini's repair Sac was separated from cord structures and dealt with according to the type of hernia, conjoint tendon was sutured onto the inguinal ligament Lichtenstein repair After dissection of the sac, polypropylene mesh was placed on the defect and fixed to the inguinal ligament below and to the conjoint tendon with sutures All participants were given pre‐operative antibiotic prophylaxis with cefotaxime and both groups were only administered spinal anaesthesia with diclofenac for postoperative analgesia. Sutures were removed 7 days postoperatively. |
|
Outcomes | Participants were evaluated postoperatively for the following outcomes.
Participants were followed up once a month for the first 3 months, once every 3 months thereafter in the first year and 6 months thereafter to a total of 18 months, assessed for recurrence and overall well‐being. |
|
Notes | Mean duration of surgery in the LMR group was significantly less than the MBR group. Pain on postoperative day 7 was significantly more in the LMR group compare to the MBR group, but no statistically significant difference was noted at day 30. 2.9% of participants undergoing LMR and 5.7% of participants undergoing MBR developed haematomas, and 22.9% of LMR compared to 8.6% of MBR participants developed seromas. 2 participants undergoing LMR repair developed postoperative wound infection. | |
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Low risk | The authors report that randomisation was performed via computer‐generated sequences from SAS software. |
Allocation concealment (selection bias) | Unclear risk | No information was offered regarding allocation concealment. |
Blinding of participants and personnel (performance bias) All outcomes | Unclear risk | No information was offered regarding blinding of participants/personnel. |
Blinding of outcome assessment (detection bias) All outcomes | Unclear risk | No information was offered regarding blinding of participants/personnel during outcome follow‐up. |
Incomplete outcome data (attrition bias) All outcomes | Low risk | Two participants in each group were lost to follow‐up. |
Selective reporting (reporting bias) | Low risk | All outcomes were reported and discussed. |
Other bias | Low risk | None identified. |