Abstract
Background and Aims:
A new technique for the repair of inguinal hernia, called Onstep, has been described. This technique places the mesh in the preperitoneal space medially and between the internal and external oblique muscles laterally. The Onstep technique has not yet been described outside the inventors’ departments. This study was based on the first 80 patients operated by the Onstep technique in a general surgical department. The objective of the study was to investigate postoperative pain and complications following the Onstep repair of inguinal hernia.
Material and Methods:
A total of 80 patients, operated in our department, were followed up in the medical files and contacted by letter. Patients were asked to fill out the Inguinal Pain Questionnaire, Carolinas Comfort Scale, and the Activity Assessment Scale, in order to assess postoperative pain.
Results:
No perioperative complications occurred. The response rate was 85% on the mailed questionnaires. No patients had any activities they were not able to perform. Activity Assessment Scale results: 80.3% did not have substantial pain-related impairment of daily function. Carolinas Comfort Scale results: 94.8% did not have a symptomatic repair. Inguinal Pain Questionnaire results: 95.5% reported no pain or pain that was easily ignored.
Conclusions:
It seems from this study that the Onstep technique is a safe method for inguinal hernia repair regarding perioperative and postoperative complications. The postoperative pain seems to be equal to or lower than after the Lichtenstein technique.
Keywords
Introduction
The optimal repair of groin hernia has been sought for decades. More than 70 different methods of repair have been described (1), all with the claim of being better or offering other advantages than previous methods. The European Hernia Society recommends the use of mesh for repair of inguinal hernia in order to mitigate recurrence (2). Recommendations include the Lichtenstein repair for open inguinal hernia repair and either the Trans Abdominal Preperitoneal (TAPP) or the Totally Extraperitoneal (TEP) repair when performing the operation laparoscopically (2). The mesh-based methods have proven valid in terms of significantly lower recurrence rates compared to open repair without a mesh (3).
With lowering recurrence rates due to improved surgical techniques, the focus on early and chronic pain as well as impairment of sexual function after hernia repair has increased (4). A range of different solutions have been suggested and investigated in order to mitigate these issues, such as different properties of mesh (5), different types of fixation methods (6–8) (i.e. glue, tacks, and self-fixating meshes) and nerve-sparing procedures (9). The laparoscopic approaches have proven to be superior in terms of reducing chronic pain and pain-related impairment of sexual function, but the recurrence rate in the early series was slightly higher than for the Lichtenstein repair, and the risk of serious adverse events was also elevated (10). Therefore, surgeons are still seeking to improve or find new ways of repairing groin hernias.
A new technique called Onstep, which merges the preperitoneal placement of the mesh from laparoscopic repair with the open incision and dissection from the open repair has been described (11). This technique places the mesh in the preperitoneal space medially and between the internal and external oblique muscles laterally. A series of almost 700 patients operated between 2005 and 2011 has recently been published, with convincing results regarding residual pain and recurrences (11). However, the technique has not yet been described outside the departments of the inventors of the technique. This study is based on the first 80 patients operated by the Onstep technique in a general surgical department, with the objective to investigate postoperative pain and complications following the Onstep repair of inguinal hernia.
Material and Methods
From December 2011 to January 2013, the Onstep technique was performed by four general surgeons on 80 patients, one patient was operated bilaterally. All patients were informed about and offered the Onstep technique preoperatively. The patients were informed that they were free to choose a Lichtenstein repair instead.
The Onstep technique is an open technique with insertion of a mesh. The skin incision is placed more cranially than the incision for a Lichtenstein repair (Fig. 1). A blunt dissection is performed between the external and internal oblique muscles. The spermatic cord is then mobilized, the hernia is handled, and a perforation is made in the transversalis fascia, close to the pubic bone. The mesh used in this technique is a Polysoft mesh. The medial part of the mesh is placed preperitoneally, and the lateral part, which is surrounding the spermatic cord, is placed between the internal and external oblique muscles (Fig. 2).
The 4-cm skin incision is placed at approximately two-finger width cranially of the symphysis and at two-finger width lateral to the midline.
On the left, the mesh is seen being placed. On the right, it is seen how a part of the mesh is placed between the external and internal oblique muscles laterally. The mesh is medially placed in the preperitoneal space.
As part of a quality study all patients were contacted in January 2013 by letter and asked to fill out the Inguinal Pain Questionnaire (IPQ) (12), Carolinas Comfort Scale (CCS) (13), and the Activity Assessment Scale (AAS) (14) in order to assess postoperative pain, comfort relating to the mesh and pain-related impairment of function. Patients were also asked to describe any complications or discomfort not otherwise covered by the questionnaires. Bilaterally operated patients responded to two questionnaires, and the hernias were analyzed separately.
The AAS asks specifically about difficulties or discomfort within the last 24 h. The AAS was analyzed by assigning a score from 1 to 5 for each of the possible answers to the 13 items (14). If an activity was not performed due to other reasons, this item was not scored, and was omitted from the analysis. The patient score was then transformed to a score ranging from 0 to 100. A score of more than 8.3 was considered as substantial impairment of function (15).
The IPQ questionnaire was developed to assess pain following groin hernia repair. The IPQ states clearly which time frame the different items relate to, for example, “right now,” “within the last week,” “how long time is the pain persisting.” The IPQ was analyzed item by item since no total score could be calculated, and the percentage given is in relation to the number of patients responding to that item.
The CCS is investigating three different aspects following mesh-based groin hernia repair: feeling or discomfort of mesh, groin pain, and limitations of movements. The CCS was analyzed according to the “Carolinas Comfort Scale—User guide.” In short, if more than two items were missing, the response from this patient was omitted from the analysis. If two or less items were missing, a replacement was done according to the manual. Response was scored from 0 to 5 (no symptoms—disabling symptoms). It is also possible to answer, “did not perform activity,” and this answer was not assigned a value. Mean values were calculated overall, and for each of the subcategories such as mesh feeling, groin pain, and limitations of movement. Symptomatic repair was defined as an overall mean of >1 or mean in any subcategory >1 (16).
All handling of data was done using SPSS version 20 (SPSS Inc., Chicago, IL, USA). This study was approved by the Danish Data Protection agency (HEH-2013-005), and being a quality control study, it did not need ethical approval according to Danish law.
Results
A total of 80 patients were identified in our electronic records of operative procedures as having received an Onstep repair of groin hernia in the inclusion period (Table 1). One patient was operated on both sides. Follow-up was first conducted in the electronic medical file in the hospital register. Intraoperative findings were 61% indirect inguinal hernias, 35% direct inguinal hernias, and 4% femoral hernias. No perioperative complications occurred. Seven of the 80 patients (8.6%) contacted the department within 30 days, with the following complaints: four hematomas, one seroma, one superficial infection, and one with complaints of feeling the mesh-ring. All were managed conservatively.
Demographics of the study population.
Managed conservatively and/or watchful waiting.
Further follow-up was done by mailed questionnaires. The response rate was 88.9%, of which one patient did not wish to participate and two patients were unable to fill out the questionnaire due to medical conditions. In total, 68 patients (85%) answered the questionnaires, with a total of 69 hernias operated (3 in women and 66 in men). Median follow-up was 4 months with a range of 1–13 months. In one patient, the ring was removed due to discomfort and pain, but following the removal of the ring with local anesthesia, this patient was pain free.
One patient has been operated due to recurrence. Furthermore, two patients had suspicion of recurrence, both confirmed by a physician. These three patients were some of the first patients operated with the Onstep technique in the department.
No significant differences were found when comparing operating time or postoperative pain between the patients operated by different surgeons. Furthermore, with the current material it was not possible to demonstrate a learning curve effect.
AAS Results
Of the respondents, 65 patients (95.6%) completed the AAS questionnaire. In all, 53 patients (80.3%) had a score of less than 8.3, which previously has been defined as no substantial impairment of function (15). No patients had any activities they were not able to perform.
CCS Results
A total of 58 patients filled out the CCS sufficiently to make calculations. A mean > 1 on the CCS has previously been considered symptomatic (Fig. 3) (16). Overall: three patients (5.2%) had a mean CCS, overall > 1. Mesh comfort: four patients (6.9%) had a mean CCS, mesh >1. Pain: three patients (5.2%) had a mean CCS, pain > 1. Movement: three patients (5.2%) had a mean CCS, move > 1. No patients reported disabling symptoms in any categories.
Histogram showing distribution of overall mean CCS score and the cumulative percent. A mean CCS score of >1 is considered symptomatic (8). The two lines represent CCS mean = 1 and the corresponding cumulative percent of the respondents = 94.8%.
IPQ Results
The results from the IPQ were not summarized like the AAS or CCS, but results were described for individual items. In all, 54 patients (80.6%) reported no pain, 10 patients (14.9%) reported pain that was easily ignored, and 3 (4.5%) reported pain that could not be ignored and interfered with daily activities. Two patients did not respond to this item. For the patients without pain, 80.9% had no pain already 1 month after the surgery. In total, three patients reported taking pain medication the last week before answering the questionnaire.
Discussion
This study is, to our knowledge, the first to investigate postoperative pain following the Onstep repair of inguinal hernia outside the inventors’ departments. These preliminary results show that the Onstep technique is safe to implement, with no perioperative serious complications. The degree of chronic pain (20% measured by the AAS, 5.2% measured by the CCS, and 4.3% measured by the IPQ) was, if not superior, then at least comparable to the results from Lichtenstein repair (16–18). However, it should be noticed that we had a wide range of follow-up time, with patients answering the questionnaires as soon as 1 month after the operation, and the results are therefore not directly comparable to other published series.
The findings in this study are not as promising as published results from the first 693 patients operated in Portugal (11); however, there are several differences between these two studies. Many of the procedures represented in this study have been used for training sessions, that is, teaching the technique, and it is expected that this procedure, as well as all other surgical procedures, has a learning curve. Another difference is the follow-up time. In this study, patients had been followed up for a median of 4 months, ranging from 1 to 13 months, compared to the standardized 12-month follow-up visit described in the first series (11). The follow-up in this study was done by validated questionnaires compared to the first study where follow-up was done by clinical examination and interviewing. No systematic approach was described regarding the clinical interview, and it is likely that it would not always cover all items as seen by the AAS, the CCS, or the IPQ. This could explain why we found a higher percentage of patients in this study with complaints. In the construction of the IPQ, the questions were chosen with the aim of reflecting a clinical follow-up (12). Therefore, the IPQ might be the best for comparing the results between the first study and our findings. On the IPQ, only 4.3% of the respondents reported pain that could not be ignored and interfered with daily activities. This number is close to the numbers in the first study, even with the shorter follow-up time. The results from the CCS (5.2% with symptomatic repair) were comparable to those from previous studies of patients with inguinal hernia. It has previously been shown that the proportion of patients with a symptomatic repair was 5.3% following TEP, 9.6% following TAPP, and 5.9% following a modified Lichtenstein repair, all with a standardized 6-month follow-up period (16).
This study could be used to guide further research regarding the Onstep technique since it may be comparable to standard open or laparoscopic treatments. However, some limitations of the study have to be considered. The population was relatively small (n = 80) and the follow-up was conducted via medical files and questionnaires and not by clinical examination. However, the response rate was high (85%), and the questionnaires have previously been validated (12–14).
In conclusion, the Onstep technique seems to be a safe method for inguinal hernia repair regarding perioperative and postoperative complications, and postoperative pain was equal to or lower than after the Lichtenstein procedure, even with a relatively short follow-up period. Further studies are needed before broader implementation into general surgical practice, which ideally should be by blinded randomized clinical trials.
Footnotes
Declaration of Conflicting Interests
Andresen and Dr. Burcharth report grants from Bard, outside the submitted work. Dr. Rosenberg reports grants and personal fees from Bard, grants from Baxter Healthcare, grants from Johnson & Johnson, outside the submitted work.
Funding
This research received no specific grant from any funding agency in the public, commercial, or not-for-profit sectors.