Early assessment of bilateral inguinal hernia repair: A comparison between the laparoscopic total extraperitoneal and Stoppa approaches.

BACKGROUND: The present clinical trial was designed to compare the results of bilateral inguinal hernia repair between patients who underwent the conventional Stoppa technique and laparoscopic total extraperitoneal repair (LTE) with a single mesh and without staple fixation. PATIENTS AND METHODS: This controlled, randomised clinical trial was conducted at General Surgery and Trauma of the Clinics Hospital, Medical School, the University of São Paulo between September 2010 and February 2011. Totally, 50 male patients, with a bilateral inguinal hernia, older than 25 years were considered eligible for the study. The following parameters were analysed during the early post-operative period: (1) The intensity of surgical trauma, operation time, C-reactive protein (CRP) levels, white blood cell count, bleeding and pain intensity; (2) quality of life assessment; and (3) post-operative complications.
RESULTS: LTE procedure was longer than the Stoppa procedure (134.6 min ± 38.3 vs. 90.6 min ± 41.3; P < 0.05). The levels of CRP were higher in the Stoppa group (P < 0.05) but the number of leucocytes, haematocrit, and haemoglobin were similar between the groups (P > 0.05). There was no difference in pain during the 1st and 7th post-operative, physical functioning, physical limitation, the impact of pain on daily activities, and the Carolinas Comfort Scale during the 7th and 15th post-operative (P > 0.05). Complications occurred in 88% of Stoppa group (22 patients) and 64% in LTE group (16 patients) (P < 0.05).
CONCLUSION: The comparative study between the Stoppa and LTE approaches for the bilateral inguinal hernia repair demonstrated that: (1) The LTE approach showed less surgical trauma despite the longer operation time; (2) Quality of life during the early post-operative period were similar; and (3) Complication rates were higher in the Stoppa group.

RCT Entities:   Population Interventions Outcomes

INTRODUCTION

The current recommendation for treatment of bilateral inguinal hernia is to repair both sides during the same surgery and anaesthetic procedure[1] and to use the mesh on the transverse or pre-peritoneal fascia.[2] Stoppa technique uses a giant pre-peritoneal prosthesis through an infraumbilical midline incision.[3] Laparoscopic hernia repair became feasible after the incorporation of the principles of the technique described by Stoppa et al., Nyhus et al., and McVay and Anson.[345] Two alternative techniques were improved and have been used routinely: The transabdominal preperitoneal (TAPP)[6] and the total extraperitoneal (TEP).[78] Both approaches use meshes larger than those used with an open anterior approach to reinforce the abdominal wall in the inguinal region and perform parietalisation of the spermatic cord structures.

Studies have shown evidence favouring the techniques with a tension-free mesh because they cause less pain and a lower post-operative recurrence. Laparoscopic inguinal hernia repair has existed for almost 20 years, but its acceptance is not unanimous. Some factors such as the need for extensive training, the tenuous benefit to the patient, and the higher cost explain the hesitation to adopt the laparoscopic approach as a standard procedure for all patients. The present clinical trial was designed to compare the results of bilateral inguinal hernia repair between patients who underwent the conventional Stoppa technique and laparoscopic total extraperitoneal repair (LTE) with a single mesh and without staple fixation.

PATIENTS AND METHODS

This controlled, randomised clinical trial was approved by the Ethics Committee for the Research Projects Analysis of the Clinics Hospital/University of São Paulo Medical School (HCFMUSP), and was conducted as part of the General Surgery and Trauma subject at HCFMUSP between September 2010 and February 2011. Prior to being included, the patients were informed about the study and then filled out the informed consent term that is standardised in the institution.

Totally, 50 patients were considered eligible for the study: Male patients with bilateral inguinal hernia (Nyhus classification), older than 25 years, with a body mass index (BMI) below 29 and with American Society of Anaesthesiologists (ASA) Class I and II. Patients with scrotal inguinal hernia, younger than 25 years, with a BMI above 29, ASA Class III and IV, as well as patients with liver disease and anaemia who were immunocompromised or who previously underwent infraumbilical surgery were excluded from the study. Randomisation was performed to offer the 50 patients the same opportunity to belong to either the 'Stoppa' group or the 'LTE' group. For that purpose, computer software determined the sequence of the surgeries (Stoppa or LTE).[9] All patients underwent the same anaesthesia and post-operative analgesia protocol.

Blood samples were collected from the patients 24 h before and 24 h and 48 h after the procedure for C-reactive protein (CRP), haemoglobin level, haematocrit level, and leucocytes/mm3 measurements. Patients responded to a questionnaire to assess their pain intensity from the 1st to 7th post-operative days, their physical functioning, the impact of pain on physical activities, and daily activities (three domains of the short form-36 (SF-36)) and post-operative comfort (Carolinas Comfort Scale). Pain intensity was assessed using the pain visual analogue scale (VAS) with values ranging from 1 (no pain) to 10 (worst possible pain). The Carolinas Comfort Scale assesses the comfort associated with eight types of usual physical movements: Bending over, standing up, sitting down, getting out of bed, coughing, walking, climbing or descending stairs and exercising.

A monofilament, macroporous polypropylene mesh (26 cm × 36 cm) was used. The mesh was cut so that its size and shape would fit the anatomical characteristics of the patient. The width of the prosthesis was determined by the distance between the two anterior superior iliac spines minus 2 cm (W). The height of the prosthesis was defined by the distance between the upper edge of the pubis to 1.5 cm above the imaginary line that joins the anterior superior iliac spines, plus 4 cm (H). The mesh was cut and configured according to the lower recesses of the retropubic and retroinguinal regions to ensure that the mesh will be well positioned and stretched without folds [Figure 1].

Figure 1

Measures used to determine the size and configuration of the mesh. L (mesh length) = Distance between anterior superior iliac spine-2 cm; H (mesh height) = Distance between the base of the penis and the imaginary line of the two anterior superior iliac spines

For Stoppa group, a Pfannenstiel incision was performed 3 cm above the pubis. Both retropubic space of the Retzius and the right and left the retroinguinal space of Bogros were dissected through this incision. The VAS deferens and spermatic vessels were dissected out and separated from the peritoneum, allowing the bilateral parietalisation of these structures. The mesh was placed between the components of the spermatic cord and the peritoneum, with no need to split the mesh. A polypropylene mesh with an appropriate size and shape was used according to the anatomical characteristics of the patient. Finally, the mesh did not display wrinkles or folds between the muscle and the peritoneum.

For LTE group, the surgery was initiated with a 3-cm transverse incision in the midline, 1.5 cm above the imaginary line that joins the two anterior superior iliac spines. A blunt dissection was performed between the transverse fascia and parietal peritoneum using a sponge clamp with gauze towards the pubis under direct vision, separating the bladder and parietal peritoneum from the anterior abdominal wall and exposing the retropubic space of Retzius. Laterally, the retroinguinal space of Bogros was dissected between the anterior wall and peritoneum until the level of the previous iliac spines. After the dissection of the pre-peritoneal space, a 10-mm permanent trocar was introduced through the incision, which was narrowed around the trocar with continuous Vicryl® 00 sutures. Carbon dioxide was then insufflated into the pre-peritoneal space until a pressure of 12 mmHg was reached. Next, a 30° laparoscope (10 mm) was introduced, and the prevesical and retroinguinal space were examined. Under the laparoscopic vision, a 5-mm trocar was then sequentially introduced in the right and left iliac fossa. The identification, dissection of the spermatic cord structures and parietalisation were similar to that performed for open surgery. After the dissection, the mesh was introduced into the pre-peritoneal space by pulling it with the thread placed in the suprapubic region that also helped to fix the mesh.

At the end of the intervention, operation duration was recorded (in minutes) and defined as the time interval between the beginning of the incision and final stitch in the skin. Complications that occurred within 15 days after the surgery were recorded.

The quantitative variables were expressed as the mean ± standard deviation and were analysed using Student's t-test. To compare the biochemical, haematological, pain and SF-36 domain parameters between the two groups and over time, two-way analysis of variance for repeated measures was used followed by the Bonferroni and Tukey's post-hoc tests. Chi-squared test was used for the proportion analysis. GraphPad software version 5.0 for Windows (GraphPad Software, San Diego, CA, USA) and SPSS version 18.0 6th edition (SPSS Inc., Chicago, IL, USA) were used for statistical analysis and to create the plots. A P < 0.05 was considered to be statistically significant.

RESULTS

A total of 50 male patients were analysed to compare the surgical procedures adopted in this study regarding the occurrence of possible changes in the first 15 post-operative days. Table 1 shows the patients and hernia characteristics and the quality of life in the Stoppa and LTE groups 24 h before the surgery (P > 0.05). Regarding the mean operation time (min), the LTE procedure was longer than the Stoppa procedure (134.6 ± 38.3 vs. 90.6 ± 41.3; P < 0.05). The levels of CRP were higher in the Stoppa group (P < 0.05), confirming that the surgical trauma was more intense in this group. The number of leucocytes and the haematocrit and haemoglobin levels were similar between the groups (P > 0.05) [Table 2].

Table 1

Patients characteristics and quality of life in pre-operative period (mean ± SD), as groups

Table 2

Values of CRP, leucocytes, haemoglobin and haematocrit on pre-operative period, 1st and 2nd post-operative day, as groups

Pain intensity [Table 3], physical functioning, physical limitation, the impact of pain on daily activities, and the Carolinas Comfort Scale [Table 4] were similar among groups (P > 0.05).

Table 3

Pain intensity value from 1st to 7th post-operative day, according to VAS

Table 4

Assessments of physical functioning, physical limitation, the impact of pain on daily activities and the carolinas comfort scale assessed on pre-operative period, 7th and 15th post-operative day, as groups

Complications occurred in 88% of Stoppa Group (22 patients) and 64% in LTE Group (16 patients) (P < 0.05). In Stoppa group, there were 11 haematomas, 11 seromas, and five bruises. In three patients, puncture were necessary. Complications of LTE group were seven haematomas, seven bruises and seven seromas, and no intervention was necessary.

DISCUSSION

The hernia repair approach was and still is another topic for discussion. In the open approach, there are debates concerning what would be the best alternative for hernia repair: Conventional bilateral hernia repair using an anterior approach or an incision either longitudinally or transversely with a posterior approach of the preperitoneal space. With the improvement of laparoscopic techniques for inguinal hernias repairs, using both the TAPP and TEP approaches, the best results of laparoscopic techniques were obtained with bilateral inguinal hernias.[1011]

In the present study, Stoppa and LTE approaches were similar regarding the extension of the dissected area in the preperitoneal space, mesh size, and procedure used to fix the meshes. The main difference between the two techniques was access: The Pfannenstiel incision was used in the Stoppa group, and the laparoscopic incision was used in the LTE group. In the present study, the preperitoneal space was dissected under direct vision without using the dissection balloon. A randomised, multicentre study compared the dissection of the preperitoneal space with and without a dissection balloon. The results showed no difference in the time spent to create the preperitoneal space, and the number of conversions was similar. The authors concluded that a dissection balloon was unnecessary, and the cost of operation was lower in the group without the balloon.[12]

Usually, laparoscopic bilateral inguinal hernia repair uses two meshes. The laparoscopic insertion and manipulation of two smaller meshes in the preperitoneal space is easier than that using a larger mesh. Some studies have reported that a larger mesh that covers the entire myopectineal orifice has the advantage of reducing recurrence near the pubis.[1213]

Another study showed no difference in the early and late outcomes when one or two meshes were used for the laparoscopic repair of bilateral inguinal hernias;[14] however, the cost was lower when a single mesh was used.[15] The intensity of the inflammatory response is directly proportional to the mesh size.[16] In the present study, a single mesh was used so that inflammatory responses to the mesh during the acute phase would be similar in the two groups.

The fixation of the mesh to the pectineal ligament, pubis, and transverse fascia followed the standard procedures used since the introduction of laparoscopic hernia repair. Because of the frequent incidence of persistent pain resulting from nerve damage by the staples, some researchers have supported non-fixation of the mesh. This idea was based on the Stoppa approach that used large meshes in the pre-peritoneal space without fixing them, obtaining good results.[317] The intra-abdominal pressure can hold the mesh in place, when a large piece of mesh is used (at least 10 cm × 15 cm) and placed without any wrinkles between the tissue layers and when the mesh covers all the hernia defect.[18] One study showed no movement of an unfixed mesh up to the 3rd month after surgery as assessed by chest X-ray.[19]

Two randomised controlled studies have shown that the non-fixation of the mesh did not increase the recurrence rate, and there was a trend toward a reduction in the incidence of neuralgia compared with the group where staples were used to hold the mesh in place.[20] In the current study, the mesh was fixed in both the TEP and Stoppa groups, with only one retropubic stitch.

In the present study, the operation time was longer in the LTE group. One study revealed that the operation time was similar between the Stoppa and laparoscopic TAPP approaches.[21] Studies comparing the Stoppa and LTE approaches also found that the laparoscopic procedure was longer.[22] In bilateral inguinal hernia repair via LTE, the amplitude of the pre-peritoneal space is smaller than when using other approaches, requiring the surgeon to perform a gradual dissection, thus explaining the longer time required for this procedure.

The CRP level was similar in both groups after the surgery. On the 1st and 2nd post-operative days, the CRP levels were statistically significantly higher in the Stoppa group. Significant differences were observed when analysing the progression of the CRP levels during the post-operative period, confirming the progressive increase in the CRP levels during the analysed periods.

During the post-operative period without complications, CRP levels rise gradually until they reach a peak on the 2nd day after surgery. Subsequently, the levels gradually decline until the 7th post-operative day. The CRP measurement is quantitative, and changes in CRP levels are directly proportional to the intensity of surgical trauma.[23] In the current study, the CRP levels indicated that the intensity of the surgical trauma was higher in the Stoppa group, confirming data from previous studies.[2224]

The leucocytes during the pre-operative period was similar in both groups. On the 1st post-operative day, the surgical trauma increased the leucocytes, similarly in both the Stoppa and TEP groups. Despite a reduction, the leucocytes remained elevated during the 2nd post-operative day, with no difference between the groups. The two surgical approaches analysed similarly increased the leucocytes, a finding that is in agreement with the literature.[1622]

The concentration of haemoglobin and the haematocrit value during the pre-operative period were similar in both groups. On the 1st post-operative day, the surgery caused a decrease in the levels of haemoglobin and haematocrit in both groups and remained stable on the 2nd post-operative day, with no differences between the groups. The haemoglobin concentration and the haematocrit value were determined to measure the occurrence of bleeding during the operation. A decrease of approximately 1 g/dL in the haemoglobin levels and a haematocrit decrease by 2% on the 1st post-operative day were not exclusively due to blood loss. The saline infusion during surgery contributed to reduced haemoglobin and haematocrit levels during the post-operative period.

Most of the studies that compare the different techniques for inguinal hernia repair use the VAS to assess pain intensity. In the literature, the VAS was applied on the 1st, 2nd and 3rd post-operative days, and all of the studies revealed that the group of patients submitted to laparoscopic surgeries had less pain than the group submitted to the Stoppa procedure.[2125]

A study revealed that not only the pain was more intense in the Stoppa group but also the analgesic consumption was higher. Another study that used on-demand analgesia reported VAS values of 5.7 and 1.7 in the Stoppa group and 4.7 and 0.7 in the TAPP group on the 1st and 2nd post-operative days, respectively. The authors concluded that Stoppa repair causes more pain than TAPP repair.[21]

In the present study, where standardised regular analgesia was used, the pain intensity assessed from the 1st to the 7th post-operative days was similar in both groups. The maximum value reached in the VAS was 3.4 on the 2nd post-operative day in the LTE group and on the 3rd post-operative day in the Stoppa group. Therefore, with regular post-operative analgesia for bilateral inguinal hernia repair, pain intensity is reduced to minimum values, regardless of the approach used.

The present study did not provide evidence of faster patient recovery in the LTE group, although there was a trend towards this outcome in this group. The values of physical functioning and physical limitation on the 7th post-operative day in both groups were smaller than those observed before surgery, showing the negative influence of the surgery in these perceptions by the patient. On the 15th post-operative day, the scores of these perceptions exceeded the value obtained before surgery in the LTE group, but the values in the Stoppa group were lower than those observed before surgery despite being greater than those on the 7th day. Considering the values obtained, a minimum of 300 subjects in each group would be required to ensure that the physical functioning and physical limitation during the post-operative period are influenced by the type of approach under the conditions used in this study.

Considering the daily activities domain, the effect of pain was similar between the groups. The pre-operative scores were similar in both groups and smaller than those obtained on the 7th and 15th post-operative days. Therefore, in the patient's perception, the pain caused by the surgery exceeded the pain caused by the hernia. This study demonstrated that the pain assessed by the VAS and its impact on routine physical activity have very close absolute values and were not a good parameter for differentiation.

The Carolinas Comfort Scale, a specific instrument to assess quality of life in patients after mesh hernia repair, analyses the feeling of pain and of the mesh and limitations when bending over, standing up, sitting down, sitting during daily activities, coughing, walking, climbing or descending stairs, and exercising.

In the present study, the obtained score indicated a small discomfort before surgery that was similar between the groups. On the 7th post-operative day, discomfort was higher in both groups, confirming the influence of the surgery on discomfort; no statistically significant difference was observed between the groups. On the 15th post-operative day, the scores of both groups returned to the pre-operative levels in both groups. According to the study that validated the Carolinas Comfort Scale, these levels correspond to the group of patients satisfied with treatment.[26]

Vascular, vesical or intra-abdominal visceral injuries did not occur during the surgery; there was no bleeding or infections in surgical wounds during the post-operative period, as described in some studies.[13] Minor complications were observed, such as the presence of bruises, haematomas, and seromas, which were present in 22 (88%) patients from the Stoppa group and 16 (64%) patients from the LTE group. This ratio was statistically significant and similar to that obtained in previous studies.[21] Haematomas from three of 11 patients from the Stoppa group were punctured to drain the collection. The others presented spontaneous absorption of the collection.

The present study indicates that laparoscopic bilateral inguinal hernia repair using the LTE approach results in less surgical trauma, as assessed by the CRP levels. However, the cellular impact was similar to that using open surgery. The pain intensity during the post-operative period was low when analgesia was administered and did not differ between the two groups, suggesting that the analgesic medication controls the pain and maintains pain at low levels of intensity, regardless of the approach used. Although the results show a trend favouring the laparoscopic approach, the present work could not conclude that the recovery was faster. A study with regular analgesia and a greater number of participants may clarify whether the recovery time is shorter using the laparoscopic approach.

CONCLUSION

The comparative study between the Stoppa and LTE approaches for the bilateral inguinal hernia repair demonstrated the following:

The LTE approach showed less surgical trauma despite the longer operation time;

Quality of life during the early post-operative period were similar; and

Complication rates were higher in the Stoppa group.