Surgery · Medical Literature
Comparison of self-fixating mesh to tack fixation in laparoscopic inguinal hernia repair: a double-blind randomized clinical trial (SELFITAC).
Abstract
To compare postoperative pain, hernia-specific Quality of Life, inflammatory response and the long-term hernia-related complaints between self-fixating mesh and limited tack fixation in laparoscopic totally extraperitoneal (TEP) inguinal hernia repair. This prospective double-blind randomised clinical trial enrolled adult males undergoing elective unilateral TEP repair between April 2018 and December 2020. The patients were randomised in a 1:1 ratio to receive either self-fixating mesh (n = 56) or limited mesh fixation with up to three non-absorbable tacks (n = 56). The primary outcomes studied were postoperative pain (Visual Analogue Scale, VAS) and Quality of Life (Carolina Comfort Scale, CCS), recorded at prespecified intervals up to 3 months. The secondary outcomes included operative time, mesh deployment time, complications, analgesic consumption, length of stay, inflammatory markers (WBC at 48 h; ESR at 3 months) and a predefined long-term follow-up to evaluate late pain, hernia-related discomfort, recurrence, contralateral hernia development, and chronic pain outcomes after at least 5 years of the index surgery. The operative duration and mesh deployment times were similar in both groups. Mesh deployment time was initially longer with self-fixating mesh in the first chronological quartile, but progressively decreased with experience and was comparable to tack fixation by later quartiles, demonstrating a significant learning-curve effect. Median VAS and CCS scores at all prespecified time points showed no clinically meaningful difference. Analgesic requirements were comparable between groups. Both groups demonstrated a significant postoperative rise in inflammatory markers; however, the magnitude of change was lower in the self-fixating mesh group, with statistically significant differences between groups in ΔWBC and ΔESR. Cord oedema and seroma were the most frequent postoperative surgical site occurrences (SSOs), with similar rates in either group. Only 96 of the 112 patients could be followed up after at least 5 years of the index surgery with an average of 78.5 months follow up. Both groups demonstrated minimal pain and mesh-related discomfort, with no clinically meaningful differences in average VAS or Carolina Comfort Scale scores. The rates of chronic pain (VAS ≥ 3) were low (four in each arm) and comparable between groups. No significant difference was observed in long-term pain-related functional impairment. One recurrence was detected in the self-fixating arm during the study. The postoperative pain scores, hernia-specific quality-of-life outcomes, and early and late complication rates, including recurrence, with the use of self-fixating mesh were comparable to those observed with limited tack fixation in TEP repair. Although inflammatory markers increased postoperatively in both groups, the magnitude of the inflammatory response was modestly lower in the self-fixating mesh group. Mesh deployment time was initially longer with self-fixating mesh but decreased significantly with experience and became comparable to tack fixation, indicating a short and clinically acceptable learning curve. These findings support self-fixating mesh as a safe and atraumatic alternative fixation strategy in TEP repair with comparable short-term and long-term pain, quality of life, and recurrence rates.
Clinical relevance
In adult males undergoing elective unilateral laparoscopic totally extraperitoneal (TEP) inguinal hernia repair, does self-fixating mesh confer superior postoperative pain control and hernia-specific quality of life compared to limited fixation with up to three non-absorbable tacks, and are these benefits sustained at long-term follow-up of at least five years? __SNAPSHOT__ {"studyDesign":"Prospective double-blind randomized clinical trial (SELFITAC)","setting":"Not reported (institution type and country not specified in the available abstract)","sampleSize":"n = 112 (self-fixating mesh: n = 56; limited tack fixation: n = 56)","population":"Adult males undergoing elective, unilateral, laparoscopic TEP inguinal hernia repair; enrolled April 2018 to December 2020","intervention":"Self-fixating mesh (type/brand not specified in the abstract)","comparator":"Limited mesh fixation with up to three non-absorbable tacks","primaryOutcome":"Postoperative pain (Visual Analogue Scale, VAS) and hernia-specific Quality of Life (Carolina Comfort Scale, CCS), recorded at prespecified intervals up to 3 months","followUp":"Short-term primary outcomes to 3 months; predefined long-term follow-up at a minimum of 5 years post-index surgery for late pain, discomfort, recurrence, contralateral hernia development, and chronic pain","fundingSource":"Not reported"}
Key findings
The provided abstract is truncated prior to reporting any numerical results for the primary outcomes (VAS pain scores and CCS quality-of-life scores) or any secondary endpoints. No absolute or relative effect sizes, confidence intervals, p-values, or rates for recurrence, chronic pain, inflammatory markers, analgesic consumption, operative duration, mesh deployment time, length of stay, or long-term outcomes are discernible from the available text. The abstract notes that operative duration and mesh deployment time were among the secondary outcomes studied, but the results sentence is cut off. No NNT or NNH can be calculated. No clinically important adverse events or complications are reported in the available excerpt. All quantitative findings must be considered not reported based on the information accessible for this summary.
Practice implications
IMPORTANT LIMITATION: Only a truncated abstract is available for this summary; the results and conclusions sections are absent. It is therefore not possible to determine whether self-fixating mesh was superior, non-inferior, or equivalent to limited tack fixation for postoperative pain or quality of life in TEP inguinal hernia repair. The study's double-blind design in a surgical trial is methodologically noteworthy and addresses an important limitation of prior research in this area. The population is restricted to adult males undergoing elective unilateral TEP repair, limiting applicability to females, patients requiring bilateral repair, recurrent hernias, and those managed via TAPP. The prespecified long-term follow-up component (≥5 years) is a meaningful strength that could address the clinically important questions of chronic pain and recurrence that shorter trials cannot answer. No change in clinical practice can be recommended from this summary alone. Clinicians should access the full publication (PMID 42490014, Hernia, July 2026) to evaluate the complete results, statistical analysis, and authors' conclusions before applying findings. __LIMITATIONS__ 1. Only a truncated abstract is available; results are entirely unreportable from the current excerpt, introducing a critical information gap. 2. The trial enrolled exclusively adult males with unilateral hernias, substantially limiting generalizability to females and patients with bilateral or recurrent hernias. 3. Sample size of 56 per arm may be underpowered to detect modest differences in pain scores or to capture infrequent outcomes such as recurrence or chronic pain, particularly for the long-term follow-up component. 4. The use of VAS and CCS as co-primary endpoints without pre-specified hierarchical testing raises potential concerns about multiplicity, though this cannot be confirmed without the full methods. 5. Blinding in a surgical device trial is inherently challenging; the mechanism of double-blinding (patient and outcome assessor, or surgeon and patient) is not clarified in the abstract. 6. A minimum 5-year follow-up endpoint is methodologically appropriate for recurrence and chronic pain, but actual follow-up completion rates and losses to follow-up are not reported. 7. Funding source is not disclosed, precluding assessment of industry sponsorship bias. 8. Generalizability may be restricted by single-center or limited-center design (setting not reported). 9. The choice of non-absorbable tacks as the comparator, rather than absorbable tacks or fibrin glue, limits the scope of conclusions regarding contemporary fixation alternatives. __BOTTOM_LINE_CATEGORY__ low_certainty __BOTTOM_LINE__ The SELFITAC trial is a double-blind RCT comparing self-fixating mesh to limited non-absorbable tack fixation in male patients undergoing elective unilateral laparoscopic TEP inguinal hernia repair, with primary endpoints of postoperative pain (VAS) and hernia-specific quality of life (CCS) up to 3 months and a prespecified long-term follow-up at ≥5 years. The abstract provided is truncated prior to the results section; no efficacy, safety, or long-term outcome data are available for this summary. Clinicians should consult the full publication (PMID 42490014) before drawing any practice-informing conclusions.