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 Table of Contents  
ORIGINAL ARTICLE
Year : 2019  |  Volume : 4  |  Issue : 1  |  Page : 29-32

A prospective randomized controlled trial of open Lichtenstein and totally extra-peritoneal repair in men with uncomplicated groin hernia


1 Department of Surgery, District Hospital Pulwama, Health Services Kashmir, Srinagar, Jammu and Kashmir, India
2 Department of Surgery, Government Medical College and Associated Hospitals, Srinagar, Jammu and Kashmir, India
3 Department of Surgery, District Hospital Pulwama, Health Services Kashmir; Department of Surgery, Government Medical College and Associated Hospitals, Srinagar, Jammu and Kashmir, India

Date of Submission27-May-2019
Date of Acceptance27-May-2019
Date of Web Publication26-Sep-2019

Correspondence Address:
Dr. Arshad Rashid
Department of Surgery, Government Medical College and Associated Hospitals, Srinagar - 190 010, Jammu and Kashmir
India
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Source of Support: None, Conflict of Interest: None


DOI: 10.4103/SJL.SJL_9_19

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  Abstract 

Objective: The objective of this study is to compare laparoscopic totally extra-peritoneal repair (TEP) with Lichtenstein repair for inguinal hernia with regard to mean operative time, complications, postoperative pain, hospital stay, return to work, cosmetic effects (scar size), and recurrence rate.
Patients and Methods: This was a prospective randomized controlled study conducted in a district hospital over a period of 3 years. One hundred and thirty-two patients of groin hernias were treated, 66 each by TEP repair and Lichtenstein tension-free repair. Patients were followed up for 1 year.
Results: The mean operative time in laparoscopic TEP was 78.56 min against 58.12 min in Lichtenstein repair (P < 0.0001). The intraoperative complication rates did not differ significantly between the two techniques (P = 0.0612). The postoperative pain scores were significantly lesser in the TEP group (P < 0.0001). The postoperative hospital stay was similar in the two groups (P = 0.7125). There was no statistical difference in the total number of postoperative complications in the two groups(P = 0.8381). The TEP group had a smaller average scar size (P < 0.0001) and returned to their activities of daily life much earlier (P < 0.0001). The recurrence rates were, however, similar between the two groups (P = 0.7861).
Conclusion: TEP offered a number of advantages over Lichtenstein repair and proved to be the sure winner.

Keywords: Groin hernia, hernioplasty, inguinal hernia, Lichtenstein repair, totally extra-peritoneal repair


How to cite this article:
Gul SI, Laharwal AR, Wani AA, Rashid A. A prospective randomized controlled trial of open Lichtenstein and totally extra-peritoneal repair in men with uncomplicated groin hernia. Saudi J Laparosc 2019;4:29-32

How to cite this URL:
Gul SI, Laharwal AR, Wani AA, Rashid A. A prospective randomized controlled trial of open Lichtenstein and totally extra-peritoneal repair in men with uncomplicated groin hernia. Saudi J Laparosc [serial online] 2019 [cited 2019 Nov 15];4:29-32. Available from: http://www.saudijl.org/text.asp?2019/4/1/29/267865


  Introduction Top


As the spectrum of laparoscopic procedures started to expand after the first laparoscopic cholecystectomy, the inclusion of laparoscopic hernia repair was not very far. The use of laparoscopic techniques for the repair of groin hernias incited a heated debate. The proponents of this technique emphasize the benefits of excellent visualization, minimal pain, less postoperative analgesia, rapid return to work, improved cosmesis, decreased wound infections, and potential cost servings secondary to decreased work loss.[1],[2],[3],[4],[5] Some studies even mention a decreased recurrence with laparoscopic techniques for hernia repair as compared to open techniques.[5],[6] On the other hand, Lichtenstein repair can be done under local anesthesia, using common surgical instruments, and thus, the operative costs can be minimum.[7],[8],[9],[10] We describe our early experience with totally extra-peritoneal (TEP) repair in comparison with Lichtenstein repair for the repair of groin hernias.


  Patients and Methods Top


This study was a prospective randomized controlled trial comprising a cohort of 132 patients, 66 each for Lichtenstein and TEP repairs. A computer-generated chart did the randomization. All the repairs were done by a single surgeon (the corresponding author, who was well experienced in laparoscopy) with the primary aim being comparison of TEP with Lichtenstein repair. Between October 2014 and October 2017, 132 patients with uncomplicated groin hernias were treated by either laparoscopic technique (TEP) or Lichtenstein tension-free repair at a district level hospital of Health Services Kashmir.

All of the cases were admitted on an elective basis, and only the uncomplicated hernias were taken up for the study. Patients with bilateral and recurrent hernias were excluded from the study along with females, children <16 years of age, and those with contraindications for general anesthesia. All of the patients were advised to empty their urinary bladder just before surgery. A standard three-port TEP repair was done with all the ports in the midline. We did not use any balloon dissector and created the preperitoneal space by blunt dissection with telescope only. Lichtenstein repair was done in the standard fashion.

Various intraoperative and postoperative parameters such as operative time, complications, postoperative pain, postoperative stay, cosmetic effects, time to return to activities of daily life, and recurrence rates were evaluated. For Lichtenstein repair, operative time was defined as the time taken from incising the skin to the time of suturing/stapling of skin, whereas for TEP, it was defined as the time taken from insertion of ports up to the closure of skin defects. Postoperative pain was measured by visual analog scale (VAS). The pain scores were obtained at 1, 2, 4, 6, 8, 12, and 24 h postoperatively. Analgesics were administered if the VAS score was >6. Wound was inspected for any soakage or signs of infection. The cosmetic effects were determined by measuring the total scar size at 60 days postoperatively. All the patients were followed in the outpatients department for a minimum period of 1 year (initially weekly for a month and thereafter monthly for the rest of the year) and the time taken for return to routine work and any recurrence was noted.

An approval from the institutional ethical committee was obtained for the purpose of this study. Written and informed consent was taken from the patients for publication and analysis of their data after explaining to them the protocol of the study in their own language. The data thus collected were compiled and analyzed using SPSS version 22 for Mac (IBM Corp., New York, 2012, USA). To calculate the P value, Fisher's exact test and Pearson's Chi-square test were applied to compare the frequencies for categorical parameters, and the unpaired t-test was used to compare the means (two-tailed) among continuous variables. The results were calculated on 95% confidence interval. A P < 0.05 was considered statistically significant.


  Results Top


During the study period, a total of 181 inguinal hernia patients were treated, out of which 49 were excluded as they did not meet the criteria of the study protocol. The remaining 132 patients were offered TEP or Lichtenstein repair in equal numbers. In the TEP group, six patients were lost to follow-up and two required conversion to transabdominal preperitoneal repair as they developed peritoneal breach and consequent loss of space and were not included for final analysis. In the Lichtenstein group, four patients were lost to follow-up and were not included for final analysis. Thus, a total of 58 patients of TEP and 62 patients of Lichtenstein repair were included in the final analysis [Figure 1].
Figure 1: The CONSORT flow diagram of the study

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Table 1: Baseline parameters of the two groups

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The baseline parameters were similar in both the groups, and all efforts were made to minimize the confounding factors [Table 1]. The mean operative time was significantly increased in the TEP group (78.56 12.31 vs. 58.12 8.68 min, P < 0.001). Though the total number of intraoperative complications were more in the TEP group as compared to Lichtenstein group, it did not reach statistical significance (4 [6.89%] vs. 2 [3.22%], P = 0.0612). Bleeding was encountered in two patients in each group (P = 0.8821). A complication unique to TEP was peritoneal breach, which was seen in 2 (3.34%) patients. There were no other intraoperative complications noted in either of the groups.

The mean postoperative pain scores (VAS) were significantly lower in the TEP group (4.63 0.42 vs. 6.71 0.53, P < 0.0001 [Figure 2]). Although wound infection and testicular swelling occurred more frequently in the Lichtenstein group, the total number of postoperative complications was similar in both the groups. The various postoperative variables are given in [Table 2]. The recurrence rate at 1-year follow-up was not statistically different in TEP group as compared to the Lichtenstein group (1 [1.72%] vs. 1 [1.61%], P = 7860).
Figure 2: Visual analog scale

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Table 2: Postoperative variables of the two groups

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  Discussion Top


To a serious and dedicated surgeon, it would be unthinkable to expect a career without being competent enough in the performance of repair for inguinal hernias. It would be unrealistic if not careless. Accounting for 75% of all abdominal wall hernias, and with a lifetime risk of 27% in men and 3% in women, inguinal hernia repair is one of the most commonly performed surgeries in the world.[11],[12],[13],[14],[15],[16] European Hernia Society (EHS) issued Grade A recommendation for both laparoscopic as well as Lichtenstein repair for primary hernias in 2009.[11] In 2012, an updated EHS meta-analysis of 27 randomized controlled trials reported significantly higher recurrence rate for TEP as compared to Lichtenstein.[12] However, an updated version of the guidelines published in 2014, excluded one randomized controlled trial (which had shown an erroneously high recurrence rate for TEP [33%]) from the 2012 meta-analysis and found no difference in the recurrence rates.[13] The current paper attempts to report on the comparison of TEP versus Lichtenstein repair in a homogenous population over 3 years with a minimum follow-up of 1 year for primary uncomplicated inguinal hernias in adult men at a district level hospital.

The surgical technique was not found to have any significant influence on the intraoperative complication rate or recurrence rate, but TEP provides all the benefits of minimal access surgery. Although the overall intraoperative or postoperative complication rates were similar in both the groups, some complications were unique to each group. As expected, peritoneal breach and surgical emphysema were only encountered in the TEP group, whereas wound infection, testicular swelling, and urinary retention were only seen in the Lichtenstein group. The findings of the present study thus confirm the validity of the decision taken by the Guidelines Group of the EHS to continue to recommend open Lichtenstein and endoscopic techniques for repair of unilateral primary inguinal hernias.[11],[12],[13],[14]

The major causes of postoperative pain are the stretching of the wound during surgery and the length of the fascial incision.[17] Our concern was that the longer operative time of TEP group might translate into more stretching of the port sites, and subsequently more post-operative pain. However, we found out that the pain was significantly more in the Lichtenstein group. This was possibly because of the reason that the length of fascial incision was more in the Lichtenstein group as compared with the cumulative length of the port-site fascial incisions. The maximum scores of pain were observed at 4 h postoperatively in both the groups, presumably due to exhaustion of the effects of analgesia and anesthesia. Less postoperative pain translated into early ambulation, acceptance of orals, and discharge of patients in the TEP group. This was also reflected in the earlier resumption of routine work by this group of patients. As most of the patients undergoing TEP were discharged within the 1st postoperative day (24-h period), we believe that this procedure might be used on a daycare basis.

The present study has some potential limitations. The sample size was small, and the population was homogenous, so extrapolation of results to other parts of the globe may not be valid. Our study was not a double-blinded one. However, the postoperative pain assessment was somewhat blinded as all scoring was performed by the attending nurse who was unaware of the ongoing study. We have also not been able to do a cost–benefit analysis of the different approaches. It was not done because we did not have a dedicated laparoscopic unit for this study and the same instruments were being used to perform other laparoscopic surgeries as well and cost assessment of wear and tear of the reusable instruments and other materials such as insufflation agents was difficult.


  Conclusion Top


TEP is superior to Lichtenstein and should be preferred as it results in less postoperative pain, better cosmesis, early resumption of routine activities, and less wound infection. Although the operative time is more in TEP, it can be decreased once more experience is gained. The recurrence rates are similar in both procedures.

Financial support and sponsorship

Nil.

Conflicts of interest

There are no conflicts of interest.

 
  References Top

1.
Schrenk P, Woisetschläger R, Rieger R, Wayand W. Prospective randomized trial comparing postoperative pain and return to physical activity after transabdominal preperitoneal, total preperitoneal or Shouldice technique for inguinal hernia repair. Br J Surg 1996;83:1563-6.  Back to cited text no. 1
    
2.
Zieren J, Zieren HU, Jacobi CA, Wenger FA, Müller JM. Prospective randomized study comparing laparoscopic and open tension-free inguinal hernia repair with Shouldice's operation. Am J Surg 1998;175:330-3.  Back to cited text no. 2
    
3.
Nicholson T, Tiruchelvam V. Comparison of laparoscopic vs. open modified Shouldice technique in inguinal hernia repair. JSLS 1999;3:39-43.  Back to cited text no. 3
    
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Liem MS, van Duyn EB, van der Graaf Y, van Vroonhoven TJ; Coala Trial Group. Recurrences after conventional anterior and laparoscopic inguinal hernia repair: A randomized comparison. Ann Surg 2003;237:136-41.  Back to cited text no. 4
    
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Misra MC, Bal S, Dewan N, Srivastava A. Laparoscopic hernia repair – What are the results? Ann Acad Med Singapore 1996;25:737-41.  Back to cited text no. 5
    
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Lau H, Patil NG, Yuen WK. Day-case endoscopic totally extraperitoneal inguinal hernioplasty versus open Lichtenstein hernioplasty for unilateral primary inguinal hernia in males: A randomized trial. Surg Endosc 2006;20:76-81.  Back to cited text no. 6
    
7.
Paajanen H. Lichtenstein inguinal herniorraphy under local infiltration anaesthesia as rapid outpatient procedure. Ann Chir Gynaecol 2001;90 Suppl 215:51-4.  Back to cited text no. 7
    
8.
Spallitta SI, Termine G, Zappulla A, Greco V, Compagno GM, Lo Iacono I, et al. Tension-free hernioplasty in the treatment of inguinal hernia in the adult: Our experience with local anesthesia and a review of the literature. Minerva Chir 1999;54:573-89.  Back to cited text no. 8
    
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Tuveri M, Calò PG, Melis G, Borsezio V, Muntoni G, Medas F, et al. Tension-free hernioplasty of recurrent inguinal hernia under local anaesthesia: A 5-year review. Chir Ital 2008;60:401-8.  Back to cited text no. 9
    
10.
Kurzer M, Belsham PA, Kark AE. The Lichtenstein repair. Surg Clin North Am 1998;78:1025-46.  Back to cited text no. 10
    
11.
Simons MP, Aufenacker T, Bay-Nielsen M, Bouillot JL, Campanelli G, Conze J, et al. European Hernia Society guidelines on the treatment of inguinal hernia in adult patients. Hernia 2009;13:343-403.  Back to cited text no. 11
    
12.
O'Reilly EA, Burke JP, O'Connell PR. A meta-analysis of surgical morbidity and recurrence after laparoscopic and open repair of primary unilateral inguinal hernia. Ann Surg 2012;255:846-53.  Back to cited text no. 12
    
13.
Miserez M, Peeters E, Aufenacker T, Bouillot JL, Campanelli G, Conze J, et al. Update with level 1 studies of the European Hernia Society guidelines on the treatment of inguinal hernia in adult patients. Hernia 2014;18:151-63.  Back to cited text no. 13
    
14.
Miserez M, Alexandre JH, Campanelli G, Corcione F, Cuccurullo D, Pascual MH, et al. The European Hernia Society groin hernia classification: Simple and easy to remember. Hernia 2007;11:113-6.  Back to cited text no. 14
    
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Grant A. Laparoscopic compared with open methods of groin hernia repair: Systematic review of randomized controlled trials. Br J Surg 2000;87:860-7.  Back to cited text no. 15
    
16.
Chung RS, Rowland DY. Meta-analyses of randomized controlled trials of laparoscopic vs. conventional inguinal hernia repairs. Surg Endosc 1999;13:689-94.  Back to cited text no. 16
    
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Rashid A, Nazir S, Kakroo SM, Chalkoo MA, Razvi SA, Wani AA. Laparoscopic interval appendectomy versus open interval appendectomy: A prospective randomized controlled trial. Surg Laparosc Endosc Percutan Tech 2013;23:93-6.  Back to cited text no. 17
    


    Figures

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    Tables

  [Table 1], [Table 2]



 

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