Incisional hernia is an important complication of abdominal surgery. Its repair has progressed from a primary suture repair to various mesh repairs and laparoscopic   repair. The repair of incisional and primary ventral hernias remains a challenge to general surgeons due to the high recurrence rates following anatomical repairs. Recurrence rates following such repairs is between 31% to 54% [1,2]. With the advent of mesh hernioplasty which is repair using a prosthetic material to reinforce the defective portion of the abdominal wall, recurrence rates have reduced to less than 10% [3].  

The unintentional side effect of the tissue dissection required for mesh placement is the increased incidence surgical site occurrences like wound related infections and other complications which is an incidence of 12% or more. [4,5, 6, 7, 8, 9,10, 11].

Presently the surgical community has rapidly accepted laparoscopic repair over the last two decades. This is primarily due to the significant reduction in wound related problems. The feasibility of laparoscopic incisional and ventral hernia repair has been clearly established with a large number of published case series, article reviews and meta-analysis. [12, 13, 14, 15, 16].

This study will compare the efficacy and safety of laparoscopic and open mesh repairs of ventral hernias including primary ventral and incisional hernias. It is intended to further verify the previously obtained results regarding the development of early and short-term postoperative complications. Therefore, the laparoscopic and open techniques of mesh hernioplasties will be compared based on the development of wound related infectious complications as the primary focus [8].

Preoperative care:

All the patients received perioperative antibiotic prophylaxis at the time of general anaesthesia induction. High-risk patients, who had a higher body mass index (BMI) or chronic obstructive pulmonary disease (COPD), were informed about chest physiotherapy with incentive inspiratory spirometry.

Operative Techniques:

Group 01- LAPAROSCOPIC REPAIR:

A Foley catheter is used to decompress the urinary bladder if the duration of the procedure was expected to be long (large defect), or if the defect was in the lower abdomen.

Creation of safe pneumoperitoneum.  The Veress needle is used to create pneumoperitoneum for all the patients. The Veress needle is inserted at the umbilicus or in the left hypochondrium depending on the previous laparotomy incision. Carbon dioxide (CO2) gas is used to achieve pneumoperitoneum, and an intraabdominal pressure of 14 mmHg was considered safe. In the case of large hernial defects, preferential distension of the hernia sac prevented adequate distension of the remainder of the abdomen. In such patients, one of the assistants has to keep the hernial sac compressed with the hand to allow CO2 to distend the remainder of the abdomen for safe performance of the operative procedure.

Port placement.  A 10-mm port is used for the 30° 10-mm telescope. Two additional 5-mm ports are placed as deemed appropriate depending on the location of the hernial defect. The placement of the ports is lateral or away from the margins of the defect so that all the margins of the defect were in view throughout the procedure. The most frequent location of the three ports was in the left flank. A 10-mm port is placed at the level of the umbilicus, with one 5-mm port above and one 5-mm port below.

Omental and bowel adhesions were taken down using monopolar diathermy or a harmonic scalpel. No effort is made to dissect the hernia sac. The defect is identified, and a careful survey of the whole parietal wall from within was performed to search for additional defects. A ball of gauze was placed over the region of the hernia defect, with a pressure dressing applied and maintained for 2 weeks. The Foley catheter was removed at the end of the procedure.

Group 02- OPEN REPAIR:

A Foley catheter is used to decompress the urinary bladder if the duration of the procedure was expected to be long (large defect) or the defect was in the lower abdomen. The skin incision is made according to the site and the size of the defect. Subcutaneous flaps are raised for 3 to 5 cm around the defect depending on the available healthy fascial tissue around the margins of the defect. The hernia sac is opened and the contents reduced. Dissection is carried forward between the posterior rectus sheath and the rectus muscle or in the lower abdomen between the rectus muscle and the peritoneum. Whenever possible, the posterior sheath/peritoneum is closed primarily with 2-0 absorbable suture. Polypropylene mesh of a suitable size (with minimum of 3 cm overlap beyond the margins of the defect) was placed between the posterior rectus sheath/peritoneum and the rectus muscle. The mesh is fixed at the four corners with 2-0 polypropylene suture taken out through abdominal muscles on the anterior rectus sheath. The anterior rectus sheath is closed over the mesh with a loop of polypropylene or nylon continuous suture if possible, without excessive tissue tension. The skin is closed over the suction drain or drains. A ball of gauze was placed over the region of the hernia defect, with a pressure dressing applied and maintained for 2 weeks. The Foley catheter was removed at the end of the procedure.

Defect and mesh size:

The operating surgeon gauges the size of the defect with the help of two, three, or four fingers (laparoscopic procedure) or with a scale (open procedure) intraoperatively, if this is not possible preoperatively because of irreducible hernia. Otherwise a USG abdomen is done to assess the defect preoperatively. A polypropylene mesh of adequate size is used in all the patients. It is ascertained that the mesh should overlap by at least 3 to 5 cm from the margins of the defect. Therefore, 15 cm x 15 cm mesh is considered adequate for defects measuring up to 8cm x 8 cm. If the multiple defects could not possibly be covered with a single mesh, additional mesh is used. 

Postoperative pain assessment and analgesic need:

Intravenous or Intramuscular diclofenac sodium 75 mg is used until the patient resumed oral intake, after which a combination of oral paracetamol and ibuprofen was administered according to the patient’s requirement. If the patient reported excessive pain, additional analgesia with injections of diclofenac sodium, tramadol, or both were given after assessment of the visual analog scale pain score on a 10-cm horizontal scale, with choices ranging from 0 (no pain) to 10 (worst pain).

Laparoscopic incisional and primary ventral hernia repair is steadily being accepted as a better alternative both by surgeons and patients. It is believed that laparoscopic repair is less painful and cosmetically superior, with a better outcome in terms of reduced hospital stay and total avoidance of recurrence and wound complications [13, 17, 18, 19]. However, a paucity of level 1 evidence makes it imperative that randomized controlled trials be conducted to assess the real benefits offered by minimal access repair of incisional and primary ventral hernia.

AIM

To study the efficacy and safety of laparoscopic mesh repair versus open mesh repair in ventral hernias during a 06-month follow-up period in a tertiary care hospital.

RESEARCH QUESTIONS

OBJECTIVES

MATERIALS

PLACE OF STUDY : 

Tertiary care teaching hospital in western Maharashtra

DURATION OF STUDY : 

18 months (Sep 2019 to Mar 2021)

STUDY POPULATION: 

Patients diagnosed with Ventral hernias: Primary ventral hernias or incisional hernias and managed at this tertiary care centre between Sep 2019 &Sep 2021.

SAMPLE SIZE CALCULATION:

INCLUSION CRITERIA

All cases presenting to this tertiary care hospital directly and diagnosed clinically with a ventral hernia.

EXCLUSION CRITERIA

Patients with obstruction or strangulation, with recurrent incisional hernia, local or systemic infection or a psychiatric illness precluding informed consent for surgery were excluded from the study as well as patients unfit for general anesthesia and pneumo-peritoneum.

SUBJECT WITHDRAWAL CRITERIA

Subjects are free to withdraw consent to participate at any point during the duration of study. 

METHODOLOGY

1. Study Design: A Randomized Controlled Trial

2. Equipment: Nil

3. Study Protocol:

(Adapted from Bailey IS et al, BMJ 199212)