Nader Shaaban MD, Maged Rihan MD, MRCS

One large Versus two meshes Fixation During laparoscopic Transabdominal preperitoneal bilateral inguinal hernioplasty : A Randomized Prospective Trial

Nader Shaaban MD, Maged Rihan MD, MRCS.

Department of General Surgery, Faculty of Medicine, Cairo University

Abstract

Background

Transabdominal preperitoneal hernioplasty (TAPP) is a feasible method for the treatment of bilateral inguinal hernia. The objective of this study is to compare the clinical outcome and cost of using one large versus using two meshes in simultaneous bilateral endoscopic TAPP inguinal hernioplasty.

Patients and Methods

Between July 2007 and February 2009, a total of 60 male patients with bilateral inguinal hernias were randomized to two equal groups and underwent bilateral TAPP: Group (A) have one large mesh and Group (B) have two meshes fixation. The primary endpoints were number of applied tacking staples, severity of pain, analgesic requirement, and incidence of seroma. Secondary endpoints were length of hospital stay, number of days required to resume normal outdoor activities and work, recurrence rate, and incidence of chronic pain.

Results

The 2 groups were comparable in age, and types of hernia. TAPP were successfully performed in all patients. The group A consumed significantly less analgesics compared with that of the group B (P =0.034). There was a significant difference in the postoperative pain score at rest and on coughing from the day of operation to postoperative day 6 between the groups. The incidence of seroma was slightly higher in group A (20 %) than in group B (10 %) (P = 0.015). Length of hospital stay and time taken to resume normal activities and work were comparable between the 2 groups. With a median follow-up of 1.2 years, no recurrent hernia has been detected in either group, but the incidence of chronic pain in the group B (23 %) was higher than that of the group A (13.6 %).

Conclusion

This randomized prospective clinical trial demonstrated a significant reduction of cost and analgesic consumption by using one large mesh fixation during bilateral TAPP, but it was associated with a minimal increased incidence of postoperative seroma.

Keywords: TAPP –Bilateral inguinal hernia- One mesh fixation.

Introduction

Following the laparoscopic revolution, laparoscopic hernia repair has become one of the commoner laparoscopic operations. Several studies have demonstrated a definite advantage over open repair with regard to reduced post-operative pain1, 2 and earlier return to work and normal activities. Bilateral hernias are repaired without extra incisions and recovery for these is very quick. 1, 3, 4

In the last years, this approach tends to become the gold standard procedure for the one day surgery of groin hernias. Transabdominal preperitoneal hernioplasty (TAPP) is a feasible method for the treatment of bilateral hernia. The laparoscopic exploration allows the intra operative diagnosis of other associated hernias. The anatomic landmarks are easily recognizable and the learning curve could be shortened. The postoperative recovery is rapid and the patient can quicker return to his normal activity; in this way, the day surgery could be considered.5

Inadequate mesh fixation has been reported to be a main cause for hernia recurrence after laparoscopic repair.6–9 Endoscopic stapling has been the most commonly adopted technique for prosthetic mesh fixation. Mechanical anchorage of the mesh not only reduces the risk of mesh migration but also enhances the bursting strength of the repair.10,11

With an increasing emphasis on the evaluation of functional recovery, acute pain has become an important outcome parameter after hernia surgery.12 Seroma is the commonest morbidity following laparoscopic hernia repair, with a reported incidence ranging from 3.4% to 11.7%. Its occurrence sometimes causes alarm to the patients as it mimics a postoperative recurrence of hernia. 13–16

The present randomized prospective trial was designed to test the null hypothesis that the early clinical outcomes including reduction of postoperative pain and cost of bilateral TAPP using one mesh are better to those using two meshes. We present a description of our technique by using one large mesh in repairing bilateral inguinal hernia, and also describe the outcome and complications we have experienced.

Materials and Methods

Inclusion criteria were age at least 18 years, male sex, medical fitness for general anesthesia, and suitability for TAPP. Between July 2007 and February 2009, 60 patients presented with bilateral inguinal hernia were included in this study. Patients who underwent concomitant operative procedures were excluded. Informed consent was obtained prior to randomization. Patients were randomized to 2 arms of treatment, one mesh group (A) and two meshes group (B), by sealed envelopes containing random number in the operation theater. A prospective collection of data using standardized data entry sheet was performed.

Surgical Technique

Patients were operated in a supine Trendelenburg's position under general anesthesia. Preoperative antibiotic, ampicillin 1 g with sulpactam 500 mg, was given intravenously on induction of general anesthesia. A 3-port technique was used, with urinary catheterization. A transverse 10-mm infraumbilical incision was made for the camera port. Carbon dioxide was insufflated to a pressure of 14 mm Hg. Another 10-mm trocar port was then inserted to the right side of the umbilicus in the midclavicular line under endoscopic guidance. The third 5-mm trocar port was placed at of the umbilicus in the midclavicular line. The pre-peritoneal space is then entered by incising the peritoneum transversely from the region of the medial umbilical ligament laterally and anterior to the hernial defect. Peritoneal flaps are then developed. Direct sacs and small indirect sacs are fully reduced. Larger indirect sacs are dissected and having freed from the cord structures, circumcised, and the distal part of a large sac is left insitu. The anatomy is then defined and the posterior flap fully developed, the dissection going at least 5cms posterior to the internal ring. In group B, the dissection is carried to the symphysis pubis medially in both sides. In group A, the dissection is carried medially anterior to the inferior epegastric vessels and the median umbilical ligament to reach the other side without incising the overlying peritoneum. In group B a 15 x 10 cm prolene mesh is then fashioned and inserted in eash side to cover the posterior wall of the inguinal canal, deep inguinal ring and femoral ring on each side. The medial border of the mesh is adjacent to the symphysis pubis and the posterior part is placed well behind the internal ring. When the mesh is satisfactorily placed, it is stapled in place, staples being applied to the pubic bone and Cooper’s ligament. Further staples are placed into the muscle layers anteriorly but none into or below the ileo-pubic tract or posterior to this. In group A a 30 x 10 cm prolene mesh is then fashioned and inserted, staples were not applied medially nor to the pubic bone, as the supporting effect of the inferior epigastric vessels and the median umbilical ligaments were replacing the role of the medial stapling fixation. The peritoneum is then reconstituted by suturing with vicryl 3/0 and the operation completed by closing the external oblique at the port sites and skin closure. Hernia types were determined intraoperatively according to the Nyhus classification.17

Postoperative Management

After assessment of the patients, they were discharged on the second day of surgery. Postoperative analgesic regimen, including oral diclofenac sodium SR 100 mg daily and paracetamol 500 mg, 3 times daily upon patients’ request, were standardized. All patients had follow-up at the outpatient clinic 1 week after discharge. During follow-up, all complications and clinical recurrence were recorded. Subsequent follow-ups were scheduled at 3, 6, and 12 months and yearly thereafter.

Outcome Assessment

The primary endpoints were number of applied tacking staples, severity of postoperative pain, analgesic requirement, and incidence of seroma. Severity of pain was assessed by a linear analogue pain score on a scale from 0 to 10 daily after operation. All patients were taught to fill in a pain score chart to document their daily pain score at rest and on coughing at home. The visual analogue pain scale is a simple-to-use instrument consisting of a 10-cm line placed horizontally on the paper with "No pain" and "The worst pain you could possibly imagine" placed at the left and right ends, respectively.

Patients were instructed to mark the spot on the line correlating to the level of all pain being experienced at the time of the medical visit. The level of pain is calculated by measuring (in millimeters), the distance from the left end of the scale to the mark. The validity, sensitivity, and reliability of the visual pain analogue scale have been confirmed. 18-20

Total amount of analgesic consumption was based on the total number of analgesic tablets consumed by the patient during the postoperative period. A seroma was defined as the clinical presence of a palpable fluid collection over the groin in the absence of bruising during follow-up.

Secondary outcome measures included operative time, length of hospital stay, number of days required to resume normal outdoor activities and work, recurrence rate, and incidence of chronic groin pain. Operative time was defined as the time from the skin incision to the placement of the last suture. Length of hospital stay was referred to the total number of nights spent in hospital after operation. Chronic groin pain was assessed by a standardized questionnaire at 1 year after operation.21

Results

TABLE 1. Patients Characteristics
P / Group B (n=30) / Group A (n=30) / Charecteristic
0.627 / 51 (40.0 – 61.0) / 49 (40.6 – 56.3) / Age yr [mean (range)]
0.153 / 62 (58.0 – 70.0) / 60 (53.5 – 66.5) / Body weight kg
0.491 / Types of hernia*[no. (%)]
6(10) / 11(18.3) / II
41(68.3) / 38(63.3) / IIIA
7(11.7) / 8(13.3) / IIIB
1(1.7) / 0(0) / IIIC
4(6.7) / 2(3.3) / IVA
1(1.7) / 1(1.7) / IVB
*Nyhus classification17

All TAPP were successfully performed, and there were no conversions to open repair. The median operative time was 105 minutes (range, 75–130 minutes) and 95 minutes (range, 70–120 minutes) in A and B groups, respectively. There were no intraoperative complications or hospital mortality.

In the first week the total number of analgesic tablets consumed by the group A (4.5 tablets; range, 2–10 tablets) was significantly less than that of the group B (7 tablets; range, 4–14 tablets) (P = 0.034).

Comparison of daily pain scores at rest and on coughing from the day of operation to postoperative day 6 between the 2 groups, showed that the mean values of the pain score is lower in group A than in group B, especially on coughing (Figs. 1 and 2).

FIGURE 1. Chart showing the mean values of daily postoperative pain score at rest in both groups.

FIGURE 2. Chart showing the mean values of daily postoperative pain score on coughing in both groups.

The median length of hospital stay was 1 day (range, 1–1 day) in group A and 1 day (range, 1–2 days) in group B (P = 0.428).

Postoperatively there were no major complications, and none of the patients had wound infection. Group A had a higher incidence of postoperative seroma (20%) than the Group B (10%) (P = 0.015). They resolved spontaneously without the need for surgical intervention.

The time taken to resume normal outdoor activities was comparable between the group A (3 days; range, 2–4 days) and group B (3 days, range, 2–5 days) (P = 0.681).

The number of tacking staples used in the fixation of the two meshes in group B ranged from 10 to 12 tacking staples, and ranged from 6 to 8 tacking staples only in the fixation of the large mesh in group A. The total cost for the use of two meshes was???????, which was greater than that for the use of one mesh.

Follow-up ranged from 8 to 27 months. With a median follow-up of 1.2 years, none of the patients was found to have recurrence. A total of 48 patients had follow-up exceeding 1 year. Of these, the incidence of chronic pain was (23%) (n = 6 of 26) in group B, which was higher than that of group A (13.6%) (n = 3 of 22).

Discussion

For the unilateral inguinal hernia, during the TAPP procedure, the use of large meshes

(100x150 mm) are recommended to reduce the recurrence rate. 22 For the bilateral hernia two meshes, 22, 23 or a single large mesh could be used like in Stoppa procedure. 24

A previous report documented that the actual tendency is to use two separate meshes technique covering the bilateral defects which is technically easier and associated with good short and long term results. 25

However, we realized in our study that the lower cost, less need for postoperative pain killers, and decrease of the acute and chronic pain reported by the patients of the one mesh group; all these factors are much more significant even if this technique needs more dissection, more operative time and has more liability for postoperative seroma formation which was self limited and did not require any intervention.

Some concern has arisen regarding the potential complications of prosthetic stapling, such as sensory nerve entrapment. To address this issue, in addition to that of cost containment, performance of laparoscopic hernia repair without fixation of the mesh has been advocated. Recent reports26–28 demonstrated comparable early recurrence rates with and without prosthetic mesh stapling, but long-term results remain to be proven. Besides, recurrence of hernia after laparoscopic repair has been attributed to an inadequate mesh fixation.29–31 Phillips et al9 suggested secure stapling of the mesh to reduce recurrence rate following laparoscopic hernioplasty.

In our trial we nullify the adverse effects which may occur due to using more staples by using only one large mesh which required less number of staples than in two meshes, especially in the medline because of the anchoring and the supporting actions of the median umbilical ligament and both the right and the left inferior epigastric vessels.

Chronic pain after inguinal hernia repair has been classified broadly as either somatic or neuropathic in origin. Somatic pain may arise from tissue injury, tissue ischemia, or the placement of staples or nonabsorbable sutures on the pubic bone.9 Meralgia paresthetica is a rare but serious potential complication of prosthetic mesh stapling.32-34 Tetik et al7 conducted a multicenter study recruiting 1514 laparoscopic repairs of inguinal hernia and reported 2 neurologic complications that required repeat laparoscopy and staple removal.

In the present trial, the use of one large mesh for bilateral inguinal hernias conferred a significant reduction of analgesic requirement compared with that of the two meshes group. This finding may be explained by using a less number of tacking staples in group A. This finding was consistent with a previous report12 documenting reduced acute and chronic pain by avoiding prosthetic stapling and encouraging biologic fixation which avoids somatic and neurologic injury associated with the use of staples.

In laparoscopic inguinal hernia repair, a potential tissue space left behind the dissected area that was created by the hernia mass naturally occurs. Occurrence of fluid collection in this pouch puts the surgeon in a dilemma about whether it is a complication or a natural process of the healing. 35–37

Seroma is the commonest morbidity following laparoscopic hernia repair, with a reported incidence ranging from 3.4% to 11.7%. Its occurrence sometimes causes alarm to the patients as it mimics a postoperative recurrence of hernia. 13–16

The prevalence of postoperative seroma was higher in group A than in group B. Our findings could be explained by the fact that more dissection is needed, especially in the midline, and the larger size of the meshes in group A stimulated a more intense reaction in the tissues that increase exudation and hence seroma formation.

Lowham et al6 conducted a multicenter study to evaluate the mechanisms leading to hernia recurrence after laparoscopic and traditional preperitoneal herniorrhaphy. Mesh lifting by hematoma and inadequate inferior mesh fixation represented the most common causes of recurrence for surgeons experienced in traditional or laparoscopic preperitoneal hernia repair. In another retrospective review of 7661 patients with 10,053 laparoscopic hernia repairs by Felix et al,8 inadequate lateral and medial fixation of the mesh were the chief mechanisms causing recurrence. As stapling of the mesh is contraindicated below the iliopubic tract, median umbilical ligament and inferior epigastric vessels serve as a complementary tool for prosthetic mesh fixation at the medial side of each defect and its ability to affix the mesh without injuring the underlying structure. This may help to reduce the incidence of chronic pain in the long run.

The main advantage of using one mesh in group A in this study was its cost, which was nearly half the cost of two meshes repair in group B. In addition to the reduction of analgesic medications, acute and chronic pain compared to group B.

Conclusion

This randomized prospective trial demonstrated a significant reduction of analgesic requirement and cost by using one large mesh fixation during bilateral TAPP, but it was associated with an increased incidence of postoperative seroma.

References

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2-Millikan KW, Kosik ML, Doolas A. A prospective comparison of transabdominal preperitoneal laparoscopic hernia repair versus traditional open hernia repair in a university setting. Surg Laparosc Endosc 1994; 4: 247-53.

3-Kiruparan P, Pettit SH. Prospective audit of 200 patients undergoing laparoscopic inguinal hernia repair with followup from 1 to 4 years. J R Coll Surg Edin 1998; 43:13-6.

4- Brooks DC. A prospective comparison of laparoscopic and tension-free open herniorraphy. Arch Surg 1994; 129: 361-6.

5- Moldovanu R, Pavy G, Popa T. Laparoscopic transabdominal preperitoneal repair (TAPP) for bilateral inguinal hernia. France Anatomie şi tehnici chirurgicale Jurnalul de Chirurgie, Iaşi, 2010, Vol. 6, Nr. 3.