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Groin hernia repair : evaluation of clinical impacts and interactions of mesh and mesh fixation

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<p dir="ltr">AIMS</p><p dir="ltr">The project underlying this thesis aimed to identify and quantify relative risk differences in reoperation rate (Papers I and II) and chronic postoperative inguinal pain (CPIP) following surgical repair of groin hernias, depending on diverse types of mesh implants and modes of mesh fixation.</p><p dir="ltr">Paper III was a preparatory study to identify relevant preoperative effect modifiers, to streamline an upcoming CPIP study on mesh/fixation combinations in laparoscopic groin hernia repair.</p><p dir="ltr">METHODS</p><p dir="ltr">The 3 individual studies were each based on large, nationwide cohorts from the Swedish Hernia Registry (SHR). For statistical analysis, Papers I and II used multivariable Cox regression. Paper III used multivariable logistic regression. P- values are 2-tailed with 95% confidence intervals (CI).</p><p dir="ltr">The predictors of interest were:</p><p dir="ltr">Paper I: Fixation suture material in the Lichtenstein repair: permanent vs long- term absorbable vs short-term absorbable sutures.</p><p dir="ltr">Paper II: Mesh/fixation combinations in laparoscopic repairs. Standard polypropylene mesh (StdPPM) vs lightweight mesh (LWM); and metal tacks vs absorbable tacks vs fibrin glue vs no fixation.</p><p dir="ltr">Paper III: Preoperative risk factors in laparoscopic repairs.</p><p dir="ltr">RESULTS</p><p dir="ltr">Paper I: 82,015 Lichtenstein repairs were included. With permanent sutures as reference (HR = 1) </p><ul><li>long-term absorbable sutures (HR 1.1; CI 0.8-1.6; P = 0.49) were not associated with an increased risk for reoperation . </li><li>short-term absorbable sutures associated with a more than doubled reoperation risk (HR, 2.2; CI 1.7-3.0; P <0.001).</li></ul><p dir="ltr">Paper II: Of 25,190 repairs, 924 (3.7%) were later reoperated for recurrence. The lowest, mutually equivalent, reoperation risks were associated with:</p><ul><li>StdPPM without fixation (reference = HR, 1) </li><li>StdPPM + metal tacks (HR, 0.8; CI 0.4 - 1.4; P = 0.39), </li><li>StdPPM + fibrin glue (HR, 1.1; CI 0.7 - 1.6; P = 0.63) </li><li>LWM + fibrin glue (HR, 1.2; CI 0.95 - 1.6; P = 0.11) </li></ul><p dir="ltr">All other LWM options correlated with increased risk:</p><ul><li>LWM + metal tacks (HR, 1.6; CI 1.02 - 2.6; P = 0.040) </li><li>LWM + absorbable tacks (HR, 2.4; CI 1.5 - 3.8; P <0.001) </li><li>LWM without fixation (HR, 2.0; CI 1.5 - 2.5; P <0.001).</li></ul><p dir="ltr">Paper III: From 82 surgical centers, 15,363 patients (33% female) were eligible, with mean age 57 years. Of 10,524 (69%) questionnaire respondents, 3,026 (29%) had CPIP according to our primary definition used for the main analysis, and 1,614 (15%) according to our secondary definition. The response rate varied significantly across some variables, particularly age.</p><p dir="ltr">Preoperative predictors significantly associated with CPIP were:</p><ul><li>female sex (OR, 1.2; CI, 1.1-2.3) </li><li>younger age (eg, <45 vs ≥65 years; OR, 1.4; CI, 1.2-1.6) </li><li>overweight (OR 1.3; CI 1.2-1.5) and obesity (OR, 1.6; CI, 1.3-1.9) </li><li>ASA 2 (OR, 1.1; CI, 1.01-1.2), and ASA ≥3 (OR, 1.4; CI, 1.2-1.7) </li><li>recurrent hernia (OR, 1.3; CI, 1.2-1.5) </li><li>femoral hernia (OR, 1.3, ;CI, 1.1-1.6) vs lateral and/or medial hernias </li><li>small (<1.5cm) vs large (>3cm) hernia defect Ø (OR, 1.2; C,I 1.03-1.4)</li></ul><p dir="ltr">CONCLUSIONS</p><p dir="ltr">Paper I:</p><ul><li>Regarding recurrence risk, long-term absorbable sutures are an excellent alternative to permanent sutures for mesh fixation in Lichtenstein inguinal hernioplasty.</li><li>Short-term absorbable sutures entail an independent risk factor for recurrence and should therefore be avoided.</li></ul><p dir="ltr">Whether there is a difference in impact on CPIP between these 2 suture alternatives needs to be explored.</p><p dir="ltr">Paper II:</p><ul><li>With StdPPM, neither mechanical nor glue fixation associated with improved outcomes. Thus, for this mesh category, we recommend no fixation. This is also, by far, the least expensive option.</li><li>With LWM, we recommend fibrin glue fixation, which was the only LWM alternative on par with non-affixed StdPPM.</li></ul><p dir="ltr">Paper III:</p><ul><li>This study identified relevant preoperative CPIP risk factors and quantified their relative impact. <br>The results can be useful in designing and interpreting other studies.</li><li>It also highlights selection bias, which appears to be a major general issue in CPIP studies but has not been satisfactorily addressed in prior reports. Future CPIP research should incorporate strategies to mitigate selection bias further.</li></ul><h3>List of scientific papers</h3><p dir="ltr">I. <b>Novik B,</b> Nordin P, Skullman S, Dalenbäck J, Enochsson L. More recurrences after hernia mesh fixation with short-term absorbable sutures: A registry study of 82 015 Lichtenstein repairs. Arch Surg. 2011;146:12-17. <a href="https://doi.org/10.1001/archsurg.2010.302" rel="noreferrer" target="_blank">https://doi.org/10.1001/archsurg.2010.302</a></p><p dir="ltr">II. <b>Novik B,</b> Sandblom G, Ansorge C, Thorell A. Association of mesh and fixation options with reoperation risk after laparoscopic groin hernia surgery: A Swedish Hernia Registry study of 25,190 totally extraperitoneal and transabdominal preperitoneal repairs. J Am Coll Surg 2022;234:311-325. <a href="https://doi.org/10.1097/XCS.0000000000000060" rel="noreferrer" target="_blank">https://doi.org/10.1097/XCS.0000000000000060</a></p><p dir="ltr">III. <b>Novik B,</b> Sandblom G, Thorell A. Preoperative risk factors for chronic pain after laparoscopic groin hernia repair: A Swedish Hernia Registry study. 2024. [Submitted]</p>
Karolinska Institutet
Title: Groin hernia repair : evaluation of clinical impacts and interactions of mesh and mesh fixation
Description:
<p dir="ltr">AIMS</p><p dir="ltr">The project underlying this thesis aimed to identify and quantify relative risk differences in reoperation rate (Papers I and II) and chronic postoperative inguinal pain (CPIP) following surgical repair of groin hernias, depending on diverse types of mesh implants and modes of mesh fixation.
</p><p dir="ltr">Paper III was a preparatory study to identify relevant preoperative effect modifiers, to streamline an upcoming CPIP study on mesh/fixation combinations in laparoscopic groin hernia repair.
</p><p dir="ltr">METHODS</p><p dir="ltr">The 3 individual studies were each based on large, nationwide cohorts from the Swedish Hernia Registry (SHR).
For statistical analysis, Papers I and II used multivariable Cox regression.
Paper III used multivariable logistic regression.
P- values are 2-tailed with 95% confidence intervals (CI).
</p><p dir="ltr">The predictors of interest were:</p><p dir="ltr">Paper I: Fixation suture material in the Lichtenstein repair: permanent vs long- term absorbable vs short-term absorbable sutures.
</p><p dir="ltr">Paper II: Mesh/fixation combinations in laparoscopic repairs.
Standard polypropylene mesh (StdPPM) vs lightweight mesh (LWM); and metal tacks vs absorbable tacks vs fibrin glue vs no fixation.
</p><p dir="ltr">Paper III: Preoperative risk factors in laparoscopic repairs.
</p><p dir="ltr">RESULTS</p><p dir="ltr">Paper I: 82,015 Lichtenstein repairs were included.
With permanent sutures as reference (HR = 1) </p><ul><li>long-term absorbable sutures (HR 1.
1; CI 0.
8-1.
6; P = 0.
49) were not associated with an increased risk for reoperation .
</li><li>short-term absorbable sutures associated with a more than doubled reoperation risk (HR, 2.
2; CI 1.
7-3.
0; P <0.
001).
</li></ul><p dir="ltr">Paper II: Of 25,190 repairs, 924 (3.
7%) were later reoperated for recurrence.
The lowest, mutually equivalent, reoperation risks were associated with:</p><ul><li>StdPPM without fixation (reference = HR, 1) </li><li>StdPPM + metal tacks (HR, 0.
8; CI 0.
4 - 1.
4; P = 0.
39), </li><li>StdPPM + fibrin glue (HR, 1.
1; CI 0.
7 - 1.
6; P = 0.
63) </li><li>LWM + fibrin glue (HR, 1.
2; CI 0.
95 - 1.
6; P = 0.
11) </li></ul><p dir="ltr">All other LWM options correlated with increased risk:</p><ul><li>LWM + metal tacks (HR, 1.
6; CI 1.
02 - 2.
6; P = 0.
040) </li><li>LWM + absorbable tacks (HR, 2.
4; CI 1.
5 - 3.
8; P <0.
001) </li><li>LWM without fixation (HR, 2.
0; CI 1.
5 - 2.
5; P <0.
001).
</li></ul><p dir="ltr">Paper III: From 82 surgical centers, 15,363 patients (33% female) were eligible, with mean age 57 years.
Of 10,524 (69%) questionnaire respondents, 3,026 (29%) had CPIP according to our primary definition used for the main analysis, and 1,614 (15%) according to our secondary definition.
The response rate varied significantly across some variables, particularly age.
</p><p dir="ltr">Preoperative predictors significantly associated with CPIP were:</p><ul><li>female sex (OR, 1.
2; CI, 1.
1-2.
3) </li><li>younger age (eg, <45 vs ≥65 years; OR, 1.
4; CI, 1.
2-1.
6) </li><li>overweight (OR 1.
3; CI 1.
2-1.
5) and obesity (OR, 1.
6; CI, 1.
3-1.
9) </li><li>ASA 2 (OR, 1.
1; CI, 1.
01-1.
2), and ASA ≥3 (OR, 1.
4; CI, 1.
2-1.
7) </li><li>recurrent hernia (OR, 1.
3; CI, 1.
2-1.
5) </li><li>femoral hernia (OR, 1.
3, ;CI, 1.
1-1.
6) vs lateral and/or medial hernias </li><li>small (<1.
5cm) vs large (>3cm) hernia defect Ø (OR, 1.
2; C,I 1.
03-1.
4)</li></ul><p dir="ltr">CONCLUSIONS</p><p dir="ltr">Paper I:</p><ul><li>Regarding recurrence risk, long-term absorbable sutures are an excellent alternative to permanent sutures for mesh fixation in Lichtenstein inguinal hernioplasty.
</li><li>Short-term absorbable sutures entail an independent risk factor for recurrence and should therefore be avoided.
</li></ul><p dir="ltr">Whether there is a difference in impact on CPIP between these 2 suture alternatives needs to be explored.
</p><p dir="ltr">Paper II:</p><ul><li>With StdPPM, neither mechanical nor glue fixation associated with improved outcomes.
Thus, for this mesh category, we recommend no fixation.
This is also, by far, the least expensive option.
</li><li>With LWM, we recommend fibrin glue fixation, which was the only LWM alternative on par with non-affixed StdPPM.
</li></ul><p dir="ltr">Paper III:</p><ul><li>This study identified relevant preoperative CPIP risk factors and quantified their relative impact.
<br>The results can be useful in designing and interpreting other studies.
</li><li>It also highlights selection bias, which appears to be a major general issue in CPIP studies but has not been satisfactorily addressed in prior reports.
Future CPIP research should incorporate strategies to mitigate selection bias further.
</li></ul><h3>List of scientific papers</h3><p dir="ltr">I.
<b>Novik B,</b> Nordin P, Skullman S, Dalenbäck J, Enochsson L.
More recurrences after hernia mesh fixation with short-term absorbable sutures: A registry study of 82 015 Lichtenstein repairs.
Arch Surg.
2011;146:12-17.
<a href="https://doi.
org/10.
1001/archsurg.
2010.
302" rel="noreferrer" target="_blank">https://doi.
org/10.
1001/archsurg.
2010.
302</a></p><p dir="ltr">II.
<b>Novik B,</b> Sandblom G, Ansorge C, Thorell A.
Association of mesh and fixation options with reoperation risk after laparoscopic groin hernia surgery: A Swedish Hernia Registry study of 25,190 totally extraperitoneal and transabdominal preperitoneal repairs.
J Am Coll Surg 2022;234:311-325.
<a href="https://doi.
org/10.
1097/XCS.
0000000000000060" rel="noreferrer" target="_blank">https://doi.
org/10.
1097/XCS.
0000000000000060</a></p><p dir="ltr">III.
<b>Novik B,</b> Sandblom G, Thorell A.
Preoperative risk factors for chronic pain after laparoscopic groin hernia repair: A Swedish Hernia Registry study.
2024.
[Submitted]</p>.

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