JOURNAL OF LAPAROENDOSCOPIC & ADVANCED SURGICAL TECHNIQUESVolume 8, Number 6, 1998Mary Ann Liebert, Inc.

A Randomized Prospective Controlled Trial ofLaparoscopic Extraperitoneal Hernia Repair andMesh-Plug Hernioplasty: A Study of 315 Cases

NAJIB KHOURY, M.D., F.R.C.S.C.

ABSTRACT

Inguinal hernias can be repaired by traditional methods, tension-free, mesh-plug hernio-plasty, and the less conventional laparoscopic techniques that have the added advantage ofquicker recovery. Between September 1994 and September 1997, a prospective randomizedcontrolled trial was performed on 292 patients with a total of 315 hernias. Of these, 150 pa-tients with 169 hernias underwent the extraperitoneal laparoscopic repair (TEP) and 142patients with 146 hernias were treated with mesh-plug hernioplasty. Patients were examinedat 1 week after surgery and every 4 months thereafter for 3 years. Operative results, post-operative recovery, complications, and recurrences were recorded. Follow-up was completefor 89% of the patients. The average operative time was 31.5 minutes for the TEP and 30.5minutes for the mesh-plug hernioplasty. The average operative time for the last 75 laparo-scopic cases was 20 minutes, 10 minutes shorter than the open-surgery group. The overallrecurrence rate was (2.5%) for the TEP and (3%) for the mesh-plug hernioplasty. Patientsundergoing the laparoscopic repair consumed less narcotic analgesic and returned to theirnormal activity 1 week sooner than the open-surgery group. A median of 8 days vs. 15 dayswas required for patients to return to work, respectively, in the TEP and open-surgery group(p < 0.01). Intraoperative complications occurred in two patients (1.3%) in the TEP repair.Both had peritoneal tear that mandated conversion to the TAPP repair. There were no ma-

jor postoperative complications. A total of 20 (13%) minor postoperative complications oc-curred in the TEP. Thirty-three (23%) minor complications occurred in the open-surgerygroup (p < 0.01). Ninety-eight percent of the patients were discharged the same day in theopen-surgery group compared to 100% in the laparoscopy group. Patients with inguinal her-nias who undergo extraperitoneal laparoscopic repair have the same recurrences and hos-pital stay but recover more rapidly, consume less analgesic, and have fewer minor compli-cations than those who undergo the mesh-plug hernioplasty.

INTRODUCTION

Inguinal hernias are common with recurrence rates ranging from less than 1% up to 15%, with a fol-low up of more than 5 years.1-4 Traditional repairs of McVay, Bassini, and Shouldice, involving ap-

Department of Surgery, Jean-Talon Hospital, Quebec, Canada.

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proximation of nonanatomically opposed tissue under tension, are responsible for the lengthy and painfulrecovery periods. The tension-free repair using a nonabsorbable mesh popularized by Lichtenstein et al.,gives good long-term results with less operative pain, quicker return to work, but requires a standard largeincision.The mesh-plug hernioplasty, as advocated by Robbins and Rutkow, is simple, rapid, with an early re-

currence rate of 0.1%. It has the added benefits of greater patient comfort and rapid return to work.Laparoscopic techniques in several small trials proved to be safe and effective; they have comparable re-

currence rates to open repair with the advantage of less postoperative pain and a more rapid return towork.7~12To our knowledge, there have been no randomized prospective trials comparing the recently introduced

tension-free plug repair with the extraperitoneal laparoscopic approach. This study was conducted to com-

pare the merits of the two types of repair in terms of recurrence rates, complications, and postoperative re-

covery.

MATERIALS AND METHODS

Patients over 18 years old with groin hernias (inguinal or femoral; primary, recurrent, and bilateral) wereassigned to either open-plug repair or extraperitoneal laparoscopic repair by random selection by cards. Ex-clusion criteria were a history of multiple lower abdominal surgery, pregnancy, and contraindication to gen-eral anesthesia. Patients were requested to attend the out-patient clinic at 1 week after surgery and every 4months thereafter for 3 consecutive years, for complete and standardized data collection on recurrence rates,recovery time, and complications. The data on postoperative complications, type, and severity of pain andresumption of daily activity was recorded by the coordinator of the 1-day surgery clinic. This was per-formed by filling out a questionnaire by phone call 48 hours after the surgery or at the first visit 1 weekafter the surgery.

The open-plug repair was performed under local anesthesia with light sedation. General anesthesia shouldhave been used for both aims of the study. We do not believe that the type of anesthesia would influencethe final outcome in terms of hospital stay, recurrence, or resumption of normal activity. The study was de-signed to compare two different techniques: one using an open approach, with the added advantage of be-ing performed under local anesthesia, while the laparoscopic approach necessitated a general anesthetic.The open technique consisted of a reduction of the hernia after a complete and high dissection of the sac

to the internal spermatic ring. A plug prosthesis is then inserted at the internal ring and its fixation securedwith absorbable sutures. An additional onlay mesh encircling the cord structures and covering the directspace is then placed without fixation.The laparoscopic technique has been described elsewhere.13 It was performed with the patient under gen-

eral anesthesia. Patients were not catheterized unless a full bladder was suspected. The technique used bal-loon dissection to develop the preperitoneal space. The sac was dissected free from the structures of thespermatic cord. A polypropylene mesh (10 X 14 cm) was placed over the hernial orifice, covering both thedirect and indirect spaces, and fixed with staples. Outpatient surgery was planned for all patients in bothgroups, with the exception of those presenting significant cardiopulmonary disease or receiving long-termanticoagulation therapy. No prophylactic antibiotic therapy was given. Operative complications related to

bleeding, injury to spermatic structures, technical defects, and conversion to transperitoneal approach as

well as cardiovascular complications were recorded. Postoperative complications related to the operativetechnique such as hematoma, seroma, swelling, wound infection, chronic pain, as well as urinary problemsand cardiovascular and pulmonary complications were assessed and documented. The severity of pain was

assessed using a numerical scale. The data collection for the pain analog scales was performed by the co-

ordinator of the 1-day surgery clinic by phone call in the first 48 hours, and at the outpatient clinic 1 weekafter the surgery. The data was gathered by filling out a questionnaire addressing the number of pain-killertablets consumed and the severity of pain on a scale of 0 to 10. The dates at which patients returned towork were recorded. Operation time (skin incision to dressing placement) and type of hernia were docu-mented from patient records.

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Statistical analysis was done using a commercially available statistics module (Microsoft, Excel version5.0) run on an IBM compatible work station. Unpaired Student's f-tests were used to compare two meansand to determine differences between groups; (p < 0.05) was considered statistically significant.

RESULTS

Between September 1994 and September 1997, we enrolled 293 patients with 316 hernias in the study.One patient with contraindication to general anesthesia was not eligible and excluded, leaving 292 patientswith 315 hernias. In the final analysis, 150 patients with 169 hernias were randomized to have the laparo-scopic repair, and 142 patients with 146 hernias the open repair. The final disparity in group sizes occurredbecause four patients with bilateral hernias randomized to the mesh-plug hernioplasty crossed over to thelaparoscopic group. They refused to have open surgery on both sides, but elected to have the laparoscopicrepair under general anesthesia. These patients should have been excluded, but were maintained. We be-lieve that the number is too small, and the statistical differences observed among measured variables were

highly significant to a degree that errors would have not influenced the final result.Randomization was successful, and the demographics of the patient population in both groups were sim-

ilar (Table 1). There were 140 male and 10 female patients in the laparoscopic group compared to 132 maleand 10 female patients in the open-surgery group. The average patient age was 48 years old (range 19-76)and 54 years old (range 18-80), respectively in the laparoscopy and open-surgery group.From the 142 patients who had an open repair, 7 underwent general anesthesia, 4 underwent spinal anes-

thesia, and 131 patients local anesthesia. All patients undergoing the laparoscopic repair had general anes-thesia.

The vast majority of operations in both groups were performed as 1-day surgery; 140 patients (99%) inthe open-surgery group and all patients (100%) in the TEP. The median operation times for unilateral, bi-lateral, and recurrent hernias in the laparoscopic group were, respectively, 29 minutes (range 5-70), 48 min-utes (range 25-80), and 27 minutes (range 10-50), and in the mesh-plug hernioplasty were, respectively,30 minutes (range 10-55 min), 50 minutes (40-70), and 33 minutes (range 15-55). The operative times ofthe first 75 laparoscopic cases were longer than those of the 75 later cases (40 vs. 20 min). Compared withthe open surgery, the median operation time of the last 75 laparoscopic cases was 10 minutes shorter (20vs. 30) (Table 2) p< 0.01.The patients in the laparoscopic surgery group required less analgesic (average four tablets aceta-

minophen + codeine for the TEP compared to nine tablets for the open repair), and fared better on a nu-

Table 1. Demographics of 292 Patients with Hernias Repaired with Open or Laparoscopic Approach

Laparoscopic TEP surgery Mesh-plug hernioplasty(n = 150) (n = 142)

Age-Year 48 (19-76) 54 (18-80)Sex-no (%)Male/Female 140/10 (93/7) 132/10 (93/7)

Femoral-No. pts. (%) 6 (4%) 4 (2.8%)Inguinal—No. pts. (%) 144 (96%) 138 (97.2%)Inguinal—No. hernias (%) 163 142Unilateral 25 (86.8%) 134 (97%)Bilateral 19 (13.4%) 4 (3%)Recurrent 13 (9%) 17 (12%)Indirect 118(72.5%) 103(72.5%)Direct 41 (25%) 34 (24%)Combined 4 (2.5%) 5 (3.5%)RT sided 66 (52.8%) 74 (55.2%)LT sided 59 (47.2%) 60 (44.8%)

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Table 2. Operative Results of Laparoscopic and Mesh-Plug Hernioplasty

Laparoscopic TEP surgery Mesh-plug hernioplastyAnesthesia

General No. (%)SpinalLocal

Operation time—Min:All typesUnilateralBilateralRecurrentFirst 75 casesLast 75 cases

150 (100%)00

31.5 min (5-80)29 min (5-70)48 min (25-80)27 min (10-50)40 min (25-70)20 min (5-35)

7 (4.9%)4 (2.8%)

131 (92.2%)

30.5 min (10-70)30 min (10-55)50 min (40-70)33 min (15-55)

metical pain scale of 0 to 10, with 0 for no pain and 10 for very severe pain (average of 3 for the TEP com-

pared to level 7 for the open repair—p < 0.01).The patients undergoing the TEP repair were able to return to work sooner than the patients in the open-

surgery group. A median of 8 days (5-13) was required for patients to resume normal work after the lap-aroscopic operation compared to 15 days (11-21) after the open repair (p < 0.01).Surgical morbidity is detailed in Table 3. There were no wound infection or major complications re-

quiring reintervention or admission in either group.Two patients in the laparoscopic group had peritoneal tear (1.3%) requiring conversion to the TAPP re-

pair: no other intraoperative complications were recorded in either group. The incidence of postoperativecomplications was 13% in the laparoscopic group compared to 23% in the open group. Six patients (4%)developed wound hematoma, three patients (2%) experienced prolonged inguinal pain that resolved spon-taneously, and 11 patients (7.3%) had cord swelling in the laparoscopic group. Six patients (4.2%) devel-oped wound hematoma, five patients (3.5%) experienced prolonged inguinal pain, and 22 patients (15.4%)had cord swelling in the open group. Cord swelling is defined as edema starting at the site of skin incision,following the course of the cord structures, continuing up to the scrotal sac. Simple swelling limited to theinguinal area was not considered as a complication.The median follow up was 17 months (range 2-36). Recurrences were diagnosed in three patients (2.5%)

in the laparoscopic group and four patients (3%) in the open-surgery group. Two of the three recurrences

in the laparoscopy group occurred in the first year. One recurrence occurred in a patient with a bilateralhernia and peritoneal tear that required conversion to the TAPP repair. All four recurrences in the opengroup occurred in the first year. One recurrence was in a patient with a recurrent hernia; the other three re-

currences occurred in a Nyhus Type III posterior wall-defect hernia.

Table 3. Postoperative Morbidity

Laparoscopic OpenDeathMajor complicationsWound infectionMinor complications

HematomaIng. painCord swelling

Total

000

6 (4%)3 (2%)

11 (7.3%)

13%

000

6 (4.2%)5 (3.5%)

22 (15.4%)

23%

p-Value<0.01.

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COMMENT

Persistent difficulties with immediate postoperative pain and inability to return to work within a reason-

able time with the traditional repairs continue to be disconcerting. The tension-free Lichtenstein and mesh-plug hernioplasty have addressed these issues with some success. Postoperative recovery remains quickerwith the laparoscopy technique, and recurrence rate in experienced hands is low.

The TEP repair using balloon dissection presents an added technical challenge. Several small trials re-

port a longer median operating time with the extraperitoneal repair than the TAPP or open techniques.14With experience, skill is acquired and the operating time with the laparoscopic technique becomes compa-rable to that of the traditional open repair. The extraperitoneal operations in this study took an average of29 minutes for unilateral hernias compared to 30 minutes with the mesh-plug hernioplasty. The median op-erating time in the last 75 extraperitoneal repairs was 10 minutes shorter than the mesh-plug hernioplasty(20 vs. 30 min). The incidence ofperitoneal breaching necessitating conversion to other operative approachesvaries in the literature from insignificant to unacceptable levels15-17 up to 16%. Peritoneal rupture man-

dated conversion to TAPP repair in 2 of 150 laparoscopic patients (1.3%) in this study. One peritoneal tearoccurred in an athletic patient, the other in a patient with adhesions caused by previous lower abdominalsurgery.Surgical morbidity was lower (13%) with the TEP than that for patients randomized to the open repair

(23%) (p < 0.01). All of these complications were minor, mostly due to hematoma and cord swelling. Thehigh rate of postoperative hematoma formation and edema after open repair can be attributed to the use oflocal anesthesia. No wound infection and no major complications were reported in either the TEP or theopen repair.

The laparoscopic herniorrhaphy is superior to the open repair with respect to postoperative pain levelsand recovery time, as reported in several trials.18,19 The results of our study indicate that patients in the lap-aroscopic group suffered less pain, required less analgesic (average four tablets acetaminophen + codeinefor the TEP compared to nine tablets for the open repair), (p < 0.01), and fared better on a numerical painscale of 0 to 10 (average 3 for the TEP vs. 7 for the open repair, p < 0.01). The patients in the laparoscopygroup returned to work sooner. The difference (a median of 7 days) in both groups was appreciable. Thisdifference is attributed to the absence of an inguinal incision and the lower complication rate in terms ofwound hematoma and swelling.Laparoscopic herniorrhaphy is comparable to the mesh-plug hernioplasty with respect to hospital dis-

charge and recurrence rate. The requirement for a general anesthesia and the technical challenge attributedto the extraperitoneal approach did not prolong the hospital stay. Patients in both groups had the same dis-charge time, over 98% leaving the hospital the same day. Recurrences were respectively 2.5% and 3% inthe laparoscopic and open-surgery group. Three recurrences occurred in the Nyhus Type III posterior walldefect, and one recurrence occurred in Type IV inguinal hernia in the open-surgery group. We believe thatfor Type III and IV inguinal hernias the mesh-plug hernioplasty is not the ideal technique. The repair shouldnot simply consist of plugging the defect; reconstruction of the weakened inguinal floor with a mesh isneeded. This can be accomplished using the Lichtenstein tension-free hernioplasty or the TEP.

The need for routine perioperative antibiotic prophylaxis with mesh repair to diminish wound infectionis now less substantiated. Rutkow and Robbins successfully completed 1563 mesh-plug hernioplasty withno prophylactic antibiotic. Their infection rate was 0.1%. All infections resolved promptly with wound care

and oral antibiotics without removal of the mesh. Our infection rate with mesh prosthesis in 315 herniaswithout a prophylactic antibiotic remain 0%.There is little doubt that laparoscopic herniorrhaphy has assumed a place in the armamentarium of sur-

gical hernia repair. Completion of an adequate learning curve under supervision by experienced surgeonsis required to reach the experience and skill needed for a safe and effective repair. The results in our studyindicate that laparoscopic extraperitoneal hernia repair has features comparable to open repair in terms ofoperative time and hospital stay, although with experience the median operating time with TEP tends to beshorter. The laparoscopic repair also has features superior to the open repair in terms of quicker recovery,less postoperative pain, earlier return to work, and fewer minor postoperative complications. At present,technical difficulty, operative complication, and conversion rate should not be considered limiting factors

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in the assessment of the laparoscopic repair. Laparoscopic repair is safe, quick, effective, even cost effec-tive in terms of our earlier return to normal work. The only drawback remains the long-term follow-up ofthe recurrence rate.

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Address reprint requests to:

Najib Khoury, M.D.Department of Surgery

Jean-Talon Hospital1385, Jean-Talon Street

Mtl, Quebec, Canada H2E 1S6

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