Prospective randomized comparison between laparoscopic and conventional hernioplasty in the treatment of ventral abdominal hernias

Prospective randomized comparison between laparoscopic and conventional hernioplasty in the treatment of ventral abdominal hernias

Ibrahim H. Othman, MD; Ashraf A. Alattar, MD; Mohamed A. Hablus, MD;

H. M Abdelhady,  MD; TahaA. Ismail, MD

Department of General Surgery, Faculty of Medicine, Tanta University, Egypt.

Objectives:  This randomized prospective study compares the effectiveness of laparoscopic ventral hernioplasty to the conventional open hernioplasty.

Patients  and methods:  Forty patients  with ventral hernias  were randomized into 2 equal groups. Group L treated bylaparoscopichernioplastyand Group 0treatedby openhernioplasty. Patients were followed for 35.5 ±15.3 months in Group L patients and 32.5 ±14.5 months in Group 0 patients.

Results:  Mean greater dimension of hernia  defect was 6.40 ±2.76 em in group L and 5.25

±2.94 ems in Group 0 (p: 0.21). In group L, mean operative time was 59.4 ± 16.4 minutes. In group 0 it was 472 ±13.8 minutes  (p: 0.016). Postoperative pain score 6 hours after surgery was 2.95±1.19 in group L patients versus 3.75 ± 0.786 in group 0 patients (p: 0.017). Group L patients needed a mean of 1.20 ± 0.410 ampoules of 100 mg Pethedine  for analgesia in the first postoperative day versus 2.15 ± 0.671 ampoules in group 0 patients (p < 0.0001).  Mean

hospitalization time  was 1.10 ±0.308  days in group  L versus 1.45 ±0.605  days in group  0 (p: 0.027).     had 1 conversion  {2.5%) to the open repair. Postoperative  seroma occurred in 2 patients (5%) in group L and 2 patients (5%) in group 0 Two patients  (5%) in group 0 developed surgical site infection. Hernia recurrence was not seenin either Group. Mean patient satisfaction score for Group L patients was 7 90 ± 1.25 versus 6.00 ± 1.72  for Group 0 patients (p: 0.0003).

Conclusion: Compared to open repair, laparoscopic repair is technically  feasible, safe and effective, with good clinical outcome. It is associated with longer time for surgery but reduced post-operative  pain, analgesic requirement,  complication rate and infection rate and earlier return to normal activities.

Key words: Laparoscopic, conventional, ventral hernioplasty.

Introduction:

The common ventral  abdominal hernias include  paraumbilical, incisional, umbilical, and    epigastric   hernias.     Primary    ventral hernias  occur spontaneously due to primary fascial  pathology.l   Postoperative ventral hernia or incisional hernia is a common complication following abdominal surgery and   is   a  significant   cause   of  morbidity.2

Incisional    hernia    develops  in   3-13%    of

laparotomy incisions.3

All    varieties    of    ventral    hernias    are

characterized by a defect  in the anterior abdominal  wall.  The optimum treatment for such  hernias  is still  under  debate  and  there are no guidelines as to the most  appropriate treatment.4

Tension-free  repair   is   one   of   the   key

concepts  in  hernia  surgery  resulting   in decrease  in recurrence rate. The laparoscopic approach for repair of ventral hernias was first reported  in the  early  1990s.  Since  that time, the technique has evolved  into an accepted repair for the management ofventral hernias.

The many reports of excellent clinical results have made laparoscopic ventral hernia repair one of the fastest growing minimally invasive techniques of the past several years as it combines the benefits of minimal recurrence and minimal wound complications.s

Laparoscopic repair of ventral hernias is rapidly becoming more common, its utility, cost-effectiveness, lower infection and recurrence rates make it very attractive.6

This randomized prospective study was designed to compare the effectiveness of laparoscopic ventral hemioplasty to the conventional open technique.

Patients and methods:

This study was performed m General Surgery Department, Tanta University Hospitals,   Egypt   during  the   period   from March 2006 to December 2011 on 40 patients with ventral hernia. Full explanation of procedures;  possible  complications  and patient consent were assured before inclusion in the research. The study protocol was approved by the Ethics Committee of General Surgery Department, Tanta University Hospitals.

Patients  were  randomly  categorized  into

2 groups through  a computer randomization program. Group L included 20 patients operated on by laparoscopic ventral hemioplasty.  This  group  was  compared  to

20  patients undergoing  conventional  (open)

ventral hemioplasty  (Group 0).

All patients underwent detailed medical history, clinical examination and abdominal ultrasound examination in addition to routine hematological and biochemical investigations for preparation for general anesthesia.

Patients  were  hospitalized  on the  day of

surgery. All procedures were performed under general anesthesia. All patients received a single dose of intravenous Augmentin 1.2 grams 30 minutes prior to surgery.

Patients in group L underwent laparoscopic ventral hemioplasty. An angled (30 degrees)

1Omm telescope  was used  in all cases.  All patients were catheterized to decompress the urinary bladder. Gastric decompression was achieved by placement of a naso-gastric tube.

The patients were placed in a supine position. Access to the abdomen was accomplished  by means of either the open technique or Veress needle in left upper quadrant except after splenectomy  and left colon surgery or other left upper abdominal surgery.

A 10 mm trocar was passed into the abdomen, located midway between left costal margin and left iliac crest along the anterior axillary line; another three 5 mm trocars were passed into the abdomen, one located at the left lower quadrant in the midclavicular  line below the level of the umbilicus, the other 2 were located in the right lower quadrant; one in the midclavicular line and one along the anterior axillary line below the level of the umbilicus.

Adhesiolysis  and  taking  down  of adherent omentum were done using sharp dissection  with  minimal  use  of  diathermy to avoid inadvertent thermal injury to the bowel.  The  hernia  contents  were  reduced but the peritoneal sac was left in-situ. The margins of the hernia defect were delineated and measured. four-layer composite mesh (PROCEED™  Mesh by Ethicon, Johnson & Johnson Company) was used.

The mesh was tailored 3 em larger than the

defect from all margins. In early cases the mesh was fixed by sutures secured at the 4 comers of the mesh passing through the anterior abdominal wall from the telescope port and picked to the outside using suture passer and tied  on the outer surface of abdominal  wall over a piece of gauze and were cut at the skin level after 2 weeks. In the latter cases the 4 comers of the mesh were fixed from inside using 3/0 polypropylene stitches not reaching to the skin. The circumference  of the mesh was then tacked at intervals of 1cm forming double crown. No drains were inserted.

For group 0 patients, the operation was done in supine position. A transverse  skin incision was done over the hernia. Dissection of  the   sac,  opening   it,  reduction   of  the contents,  and excision of sac was done with closure   of  the   peritoneum.   Polypropylene mesh  was inserted  as a sublay  repair under the defect in the preperitoneal space either immediately  over the  closed  peritoneum  or

over a closed fascial layer after component separation.

In  both  situations  the  mesh  was  fixed and  spread  in  the  preperitoneal   space  by

3/0  polypropylene  comer  stitches  tied  over the fascial layer after closure of the defect. Closure of the defect was done using 1 polypropylene stitches. Skin was closed with suction drainage.

Patients  were  allowed  to  drink  3  hours after  recovery.  Analgesia  was  given  in the form of 100 mg Pethedine on recovery and another  100  mg  Pethedine  intramuscularly after 12 hours ifthe patient complains of pain. Postoperative  pain  was  measured  6  hours after surgery using pain visual analog scale.

Patients   were  discharged   from  hospital in the first post-operative morning in most cases. Patient satisfaction score was designed by asking patients to express their satisfaction in a numerical score from 0 to 10 one month after surgery.

Patients  were followed  in visits  at three day  interval  for  two  weeks  then  every  3 months. Patients that did not come for follow up  were  contacted  by  telephone.   Patients were encouraged to visit the clinic at any time if they have any problem. The mean length of follow up was 35.5 ±15.3 months in Group L patients and 32.5 ±14.5 months in Group 0 patients.

Statistical analysis: Quantitative variables were expressed as mean ±SD. Qualitative variables were expressed as frequency and percent.   Quantitative   parametric   variables were compared between the two groups using the unpaired student t-test, quantitative non­ parametric variables were compared using Mann-Whitney  test.  Qualitative  variables were   compared   using   Chi-square   test   or Fisher exact test when the criteria for using Chi-square  were  not  sufficient.  The  power used was 0.80 while the level of significance was 5%.

Results:

The demographic characteristics of patients studied, types of hernia and size of hernia defect were summarized in Tables(l- 3).

Operation time: In group L, operative time

ranged from 40-95 minutes (mean operative time: 59.4 ± 16.4 minutes). In group 0, operative time ranged from 35-90 minutes (mean operative  time:  47.2 ±13.8 minutes). The difference between the two groups was statistically significant (p: 0.016).

Postoperative  pain:  Postoperative  pain score  measured  6  hours  after  surgery  was

2.95±1.19  in  group  L  patients  versus  3.75

±0.786 in group 0 patients (p: 0.015). Group L patients needed a mean of 1.20 ± 0.410 ampoules of 100 mg Pethedine for analgesia in the first postoperative day. Group 0 patients needed a mean of 2.15 ±0.671 ampoules  of

100 mg Pethedine for analgesia in the first postoperative day (p < 0.001).

Hospitalization time: Hospitalization time ranged from 1-2 days in both groups. Mean hospitalization  time was 1.10 ±0.308 days in group  L. In group  0, mean  hospitalization time was 1.45 ± 0.605 days. The difference between the two groups was statistically significant (p: 0.026).

Time to  return  to  normal  activity:  Time to return to normal activity ranged from  4-8 days  in  group  L (mean  time:  5.65  ±0.988 days). In group 0, time to return to normal activity ranged from 6-27 days (mean time:

14.4  ±4. 90  days).  The  difference  between the two groups was statistically significant (p<0.001).

Complications:    We  had   to   convert   1 patient (2.5%) to the open repair due to lack of experience at the start of our research. postoperative seroma occurred in 2 patients (5%) in group Land  2 patients (5%) in group

0. All patients  were successfully  treated conservatively.  Two patients  (5%)  in group

0 developed  surgical  site  infection.   They were managed by proper antibiotic according to culture and sensitivity result. Hernia recurrence  was not seen in either 2 Groups. The difference between the complication rates in two  groups  was statistically  insignificant (p: 0.661). Post-operative complications are summarized in Table(4).

Patient satisfaction: The mean patient satisfaction  score  for  Group  L patients  was

= 7.90  ± 1.25 versus 6.00  ± 1.72 for  Group

0 patients.  The difference  between  the two

groups was statistically significant (p:  0.049).

Discussion:

A lasting surgical correction of a ventral hernia remains a challenge. Open primary suture repair has led to extremely high recurrence rates. For a fascial defect equal to or more than 4cm in size, the recurrence rate exceeds  40%.  For a fascial  defect  less than

4cm in size, the recurrence rate can be as high as 25%.7

The use of prosthetic mesh came to popularity after it was shown that the  long­ term  failure rate could be reduced to 11%.7

However, the placement of mesh typically required  extensive  soft tissue  dissection, raising of flaps and insertion of drains, increasing  the incidence  of wound  infection and local wound complications.8-10

The laparoscopic repair of ventral hernia utilizes the principles  of the open technique popularized by Stoppa, Rives et al. and Wantz.11-13 These principles include using large  mesh  prosthesis,  adequate  overlap  of the  hernia  defect,  and  eliminating  tension. In the laparoscopic technique, the mesh is placed intraperitoneally and extensive soft tissue dissection is eliminated.

Intraperitoneal  placement of mesh without sac excision seems to be the near-universal method of mesh positioning.14

All  of  the  hernias   in  our  series   were repaired with four-layer composite mesh (PROCEED™  Mesh by Ethicon, Johnson & Johnson Company). The polypropylene mesh side of the product allows for tissue ingrowth while  the  ORC  (oxidized  regenerated cellulose) side provides a bioresorbable layer that physically separates the polypropylene mesh from underlying tissue  and organ surfaces   during  the  wound-healing   period to   minimize   intestinal   attachment   to  the

mesh_9,15,16

The   ORC   side    appears   to    be   less easily   infected   than   other   biomaterials.17

It is therefore  recommended  that  mesh materials be separated from the intestine, whenever possible.18-20 For this purpose, the PROCEED™ Mesh is well suited.

Intra-abdominal    placement   of   a   large

mesh with wide overlap of defects, use of smaller  incisions,  laparoscopic  adhesiolysis to   uncover  small   unpalpable   defects  that may go unnoticed with open repair, and use of large non-absorbable sutures for stronger patch fixation could account for the greater success of the laparoscopic operation.21

It has been shown that with laparoscopic

repair of ventral hernia wound complication rate,  patient  discomfort,  length  of  hospital stay,  time   to   return   to  normal   activities and   recurrence   rates  are  all  reduced. 22,23

Laparoscopic repair of ventral hernia has also been established as a cost-effective procedure, with total facility costs for the laparoscopic repair being significantly lower than that for the open repair.24

The maJor complications following laparoscopic   repair   of   ventral   hernia   are well documented. These include enterotomy, mesh infection, skin breakdown, intra­ abdominal abscess and mortality. The overall complication  rates range from 0% to 24%.25

There were no operative mortalities or major

complications in our series.

It has  been  observed  that  seroma  at the site  of  hernia  repair  and  suture  site  pain were the most common minor complications reported!.5,20,26

Seroma is defined as any bulge at the operation  site  observed  by  the  surgeon  or the  patient. It is considered  significant  if  it lasts more than six weeks. We found that all of  them  resolved  without  treatment  within six weeks. Heniford et al., recommended aspirating seromas in patients who are symptomatic,  and allowing the others to resolve spontaneously.27

The suture site pain experienced may originate from tissue or nerve entrapment during placement of sutures or tacks through the full thickness of the anterior abdominal wall. It could result from traction  of the transabdominal  sutures  fixing  the  mesh  to the anterior abdominal wall. However, suture placement is vital to the long-term durability of the mesh  repair  and we do not  advocate any change in the technique. Suture site pain can be managed conservatively. In our series suture site pain was not realized because we

Figure {1): Reduction of the hernia content by adhesiolysis using harmonic scalpel.

Figure {3): Fixation of the mesh   from inside using 3/0 polypropylene stitches not reaching to the skin at the four corners.

Figure {5): lncisional hernia before opening the hernial sac. .

used a single suture in every comer fixed fi:om inside and not reaching to the skin.

The recunence rate in our seties was 0%,

Recunence   rates   following   laparoscopic

Figure {2): The hernial defect after reduction of the content.

Figure {4): Spreading of the folded mesh over the defect with stapler fixation of the mesh .

Figure {6): The hernial defect after reduction of the contents and excision of the hernial sac and closure of the peritoneum..

repair in other 60 seties  averaged 3.61  %

repair in the meta analysis of Carlson et al.,14

Table(3).

Sauerland et a1.,28 compared laparoscopic

Figure {7): Spreading of the  mesh in  the preperitoneal space by comer stitches {clock face technique) tied over the aponeurotic layer after closure of the defect.

Figure {8): Closure of the      hernial defect using interrupted polypropylene stitches.

Table (1): The demographic characteristics of patients.

Table (2): Types of hernia.

Table (3): Greater dimension of hernia  defect.

The difference in mean greater dimension  ofhernia defect is statistically insignificant (p: 0.143).

Table (4): Postoperative complications in both groups.

Table (5): Summary of major outcome data oflaparoscopic ventral hernia repair in the meta­

analysis of Carlson et al.,(14).

t The rough mean is the total number of events divided by the total number of procedures (data

on all outcomes were not available in all ofthe manuscripts)

with  open  repair   m  patients  with  ventral hernia. They     selected            10         randomized controlled  studies  which  compared  the two techniques with a total number of880 patients. The recurrence rate was not different between laparoscopic  and  open surgery. The risk  of intraoperative enterotomy was slightly higher in laparoscopic hernia repair. The most clear and consistent  result  was that  laparoscopic surgery reduced the risk of wound infection. Laparoscopic surgery shortened hospital stay significantly in 6 out of 9 trials. Laparoscopic repair  apparently  led  to  much  higher   in­ hospital   costs.   They   concluded   that   the

short-term results of laparoscopic repair m ventral hernia are promising.  In spite of the risks  of  adhesiolysis,  the  technique  is safe but  long-term  follow-up  is needed  in order to elucidate whether laparoscopic repair of ventral hernia is efficacious.

Laparoscopic repair of ventral hernia can

essentially  be extended  to  any  patient  who is a candidate for open repair and with an acceptable risk for general anesthesia.29 As experience   increases,   laparoscopic    repair of  ventral   hernia  can  be  safely  extended to patients with multiple prior abdominal procedures and large hernias.30 Incarceration

is not a contraindication as onset of anesthesia, muscle relaxation and introduction of pneumoperitoneum make reduction easy.

Conclusion:

Compared to open repair, laparoscopic repair  is technically  feasible,  safe  and effective,   with  good   clinical   outcome.   It is  associated  with  longer  time  for  surgery but reduced post-operative pain, analgesic requirement, complication rate and infection rate and earlier return to normal activities.

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