A Prospective Nonrandomized Study of Comparison of Perioperative and Quality of Life Outcomes of Endoscopic Versus Open Inguinal Hernia Repair: Data from a Developing Country

Introduction

Patient care now has expanded from not simply curing the disease, but also improving quality and safety of the medical intervention. Of late, inguinal hernia repair was considered a success if the patient had a healed wound without evidence of infection or recurrence in the perioperative period. If at all patients returned with local discomfort, the only option left with the surgeon was counseling as there was no proper tool to measure or evaluate pain. Although surgeons thought that they were doing a good work by just treating the hernia, a surgery with low recurrence and complication rates, they ignored an important aspect of medical science that deals with quality of life (QOL). ¹

Repair of inguinal hernias affects patients' QOL and comfort postoperatively. ² Although many surgeons opine that the mesh is the cause of localized discomfort following inguinal hernia repair, until recently it was not assessed due to dearth of potential tools. The introduction of newer validated hernia-specific QOL questionnaires such as the Carolinas Comfort Scale^® (CCS) ³ has empowered surgeons to ask relevant questions to the patients in the postoperative period.

With the advent of endoscopic hernia surgery in developing countries like India, there is paucity of published research data in terms of QOL in inguinal hernia surgery. Therefore, we compared perioperative and QOL outcomes following endoscopic versus open repair of inguinal hernia in a prospective nonrandomized setting.

Materials and Methods

A prospective nonrandomized study was conducted in the Department of Surgery, King George's Medical University, Uttar Pradesh, over a period of 1 year from September 2014 to August 2015. All consecutive patients with uncomplicated symptomatic primary unilateral/bilateral and ASA Grade I and II tagged for hernioplasty (open or endoscopic) were included in the study. Exclusion criteria included ASA grade ≥III, BMI >30 kg/m², history of multiple abdominal surgeries, coagulopathy, significant comorbidities like coronary artery disease, asthma, chronic obstructive pulmonary disease, patients requiring other concomitant procedures, patients who did not give consent for participation in the study, or patient with cognitive impairments. Ethical clearance from the Institutional Ethics Committee was taken. The procedure (open or endoscopic) was explained in detail and informed and written consent was taken before enrolment.

Outcome assessor (nurse assistant) was blinded and the study constituted enrolling patients in a nonrandomized prospective manner (based on patient's preference) into two groups—group I (open inguinal hernia repair [OIH]—Lichtenstein hernioplasty) n = 64 and group II (endoscopic inguinal hernia repair [EIH], totally extraperitoneal repair [TEP]/transabdominal preperitoneal) n = 36. All surgeries were performed by a single senior consultant surgeon with an experience of more than 5 years of laparoscopic surgery. Perioperative outcomes were compared in terms of duration of operation, duration of hospital stay, intraoperative complications (injury to vessel nerve and visceral organ or bowel), postoperative complications (surgical site infection [SSI], scrotal swelling, pain, and thigh pain and numbness), and time to return to routine work and office work after discharge from the hospital. Routine work was defined as resuming daily necessary activities like bathing, doing household work, etc. Office work was defined as performing all activities, including job-related work barring lifting heavy weight and doing strenuous exercises. CCS was used to assess QOL posthernioplasty and was administered in preoperative and at the first, third, and sixth month in the postoperative period.

Statistical analysis was performed using unpaired t-test, chi-square test, and Mann–Whitney U test. All P-values were considered significant at P < .05.

Results

Mean age for OIH was 39.1 ± 8.0 years (male 61; female 3). The mean age for EIH was 41.3 ± 8.3 years (all male). Mean operative duration was significantly longer in EIH compared with OIH (102.5 ± 11.9 minutes versus 66.9 ± 12.7 minutes, P = .001). However, the mean duration of hospital stay was significantly reduced in EIH compared with OIH (2.6 ± 0.6 days versus 5.7 ± 1.3 days, P = .001).

Intraoperative complications (0% versus 2.8%, P = .28) and postoperative complications, such as urinary retention (6.2% versus 8.3%, P = .69) thigh pain and numbness (3.1% versus 5.6%, P = .55), and scrotal swelling (7.8% versus 16.7%, P = .17), were comparable in both the groups (OIH versus EIH), respectively, except for SSI, which was more with OIH (20.3% versus 5.6%, P = .04), and postoperative pain (Visual Analogue Score [VAS]) scores, which were reduced in EIH (VAS pain scores 2+/3+; OIH 24 (37.5%)/40 (62.5%) versus EIH 22 (61.1%)/14 (38.9%); P = .02).

Mean time to return to routine work was significantly shorter in EIH compared with open repair (OIH versus EIH: 5.8 ± 1.1 days versus 3.7 ± 0.8 days, P = .001). This translated into a significantly shorter time to return to office work in EIH (OIH versus EIH: 12.3 ± 1.9 days versus 7.6 ± 0.8 days, P = .001).

Comparing various parameters for assessment of QOL in two groups demonstrated a significant decrease in terms of sensation of mesh, postoperative pain, and movement limitation in EIH group with a trend showing significant improvement in all parameters in both groups with time duration (Table 1).

Discussion

The mean operative time was significantly longer in EIH, whereas hospital stay was significantly decreased in EIH compared with OIH, which is consistent with published literature so far. With regard to operative duration, most evidence in the literature favors a shorter operative duration with open repair. ⁴ A meta-analysis reported by Memon et al. ⁵ concluded that there is a significant increase of ∼15 minutes when endoscopic method is applied for treatment for hernia, but with early discharge from the hospital. A Cochrane systematic review by McCormack et al. ⁶ had also stated a significantly longer duration of operation in endoscopic techniques with a mean prolongation of 14.8 minutes compared with open techniques with length of hospital stay showing no difference. Comparing specifically, the Lichtenstein repair with endoscopic repair techniques, Schmedt et al., ⁷ in a systematic review, reported a shorter operating time for open hernioplasty (difference of 5.45 minutes). The laparoscopic approach to inguinal hernia repair was also associated with a steeper learning curve probably due to increased complexity and technical difficulty of the surgery resulting in longer operative duration, but with reduced hospital stay. ⁷ In the present work, the operative time in endoscopic group was longer than the literature cited above. The possible reasons were, first, the learning curve of the surgeon (who has performed around 60 TEP procedures) falls in the range described by European hernia guidelines 2009, ⁸ and second, the site of the study being a medical teaching university, where medical students and surgery postgraduate residents are demonstrated and trained during the procedure.

Time to return to work was taken as another parameter of clinical outcome. The results of this clinical report correlate with the general consensus in the literature that patients who undergo EIH return to work and normal activities more rapidly than those who undergo open repair. Langeveld et al. ⁹ described significant faster recovery of daily activities and less absence from work with endoscopic hernia repair. Liem et al. ¹⁰ reported that patients who underwent laparoscopic repair resumed normal daily activity 4 days earlier (P < .001), returned to work 7 days earlier (P < .001), and resumed athletic activities 12 days earlier (P < .001) than those who had open repair. Memon et al. ⁵ in their meta-analysis and Cochrane systematic review by McCormack et al. ⁶ also showed quicker return to normal activity and subsequently to work in endoscopically operated group. The timing of return to activity after hernia repair can be affected by postoperative persisting pain or intraoperative or postoperative complication. Time to return to routine activities and time to return to office work were significantly improved in EIH. This might be because of early discharge from the hospital, less postoperative pain, and fewer perioperative complications in EIH group.

This study did not find any mentionable difference in intraoperative and postoperative complications like urinary retention, thigh pain and numbness, and scrotal swelling, except for incidence of SSI and postoperative pain VAS scores, which were significantly lower in EIH. All the reported SSI were superficial in nature and were treated with oral antibiotics for 5 days. Increased SSI rates probably contributed to a longer hospital stay in the OIH group. The reported incidence was higher in our study compared with the standard surgical infection rate of 3%–5%. The plausible factors may be external environment (higher humidity in India, being a tropical country), patient factors (most belonging to low socioeconomic status not maintaining a good personal hygiene, having comorbidities like diabetes), and operative factors (longer operative duration, long and varied operative list). ¹¹ To overcome this menace, several methods have been adopted by the authors presently, namely, reducing preoperative stay, scheduling all hernia cases on priority in the operating list, ensuring local hygiene, and judicious use of perioperative antibiotics. A possible factor in the variable incidence of postoperative pain may be the type of repair employed. Although the Cochrane data ⁶ predicted a higher risk of serious complication rate in respect to visceral (especially bladder) and vascular injuries with endoscopic procedures because of longer operating hours, subsequent evidence did not seem to support this view. Schmedt et al. ⁷ had reported significant advantages for the endoscopic procedures compared with the Lichtenstein repair, which included a lower incidence of wound infection, a reduction in hematoma formation and nerve injury, and fewer incidences of chronic pain syndrome with no difference in total morbidity or in the incidence of intestinal lesions, urinary bladder lesions, major vascular lesions, urinary retention, and testicular problems. Similarly Memon et al. ⁵ echoed a significant reduction of 38% in the relative odds of postoperative complications in endoscopic group. Lately, in a randomized control trial reported by Langeveld et al., ⁹ incidence of adverse events during surgery was significantly higher with TEP, but postoperative complications were similar when comparing TEP and Lichtenstein repair. Therefore, this LEVEL-trial concluded that TEP is recommended in experienced hands. Pokorny et al. ¹² had recounted no difference in intraoperative and postoperative complications in a prospective randomized multicenter trial.

In literature, QOL had been studied by Short Form-36 (SF-36) and CCS questionnaire. The SF-36 questionnaire is the most popular instrument utilized to quantify the degree of pain and discomfort. The SF-36 concentrates on four domains of QOL related to vitality, social functioning, and emotional and mental health, which are more applicable to patients with chronic illnesses. Myers et al., ¹³ in a prospective analysis, and Abbas et al., ¹⁴ in a randomized control trial, have shown better QOL scores with endoscopic repair using SF-36 questionnaire. For patients undergoing inguinal hernia repair or suffering from other benign medical conditions, a disease-specific QOL questionnaire is preferred.^15,16 The CCS is an ideal tool for assessing patients' QOL posthernia repair, but its use has been hardly investigated preoperatively and in developing countries like ours. This analysis concluded that QOL is significantly improved in EIH with increasing postoperative duration viz a viz OIH. However, Heniford et al. ¹⁷ proposed a new QOL survey CCS that specifically pertained to patients undergoing hernia repair with mesh and found that when compared with SF-36, it assessed patients' outcome and satisfaction more satisfactorily. Lately, Christoffersen et al. ¹⁸ demonstrated that health-related QOL assessed with CCS changes significantly over a period of time, over a period of 3 months. Gholghesaei et al. ¹⁹ in a narrative review had concluded that from a societal perspective, endoscopic repair entails costs similar to open repair, but offers extra benefits to patients in terms of QOL and pain.

Conclusions

Endoscopic hernia repair offers reduced hospital stay, equivocal perioperative complications, reduced postoperative pain, and early return to normal activity and work. This assumes importance in developing countries as most of the patients are the sole earning member in the family. QOL is also significantly improved with endoscopic repair with a considerable change for better with time.