Role of enhanced recovery after surgery in total laparoscopic hysterectomy.

INTRODUCTION: Enhanced recovery after surgery (ERAS) principles is an evidence-based surgical management approach that requires cooperation across various medical specialties. In this study, we applied ERAS principles in total laparoscopic hysterectomy (TLH) and the post-operative outcomes like post-operative pain, nausea and vomiting, opioid requirement, day of discharge, and any other complaints were studied.
METHODS: The study was conducted in a private healthcare setup in Jodhpur, Rajasthan, India. In this non-randomised controlled study 103 patients who underwent TLH over a period of 1 year were alternatively allocated to the study group and the control group. There were 51 patients in the study group in whom ERAS principles were applied and 52 patients in control group in whom traditional post-operative care was given.
RESULTS: Post-operative nausea and vomiting and opioid requirement were significantly reduced in the study group (P < 0.05). The post-operative pain was similar in both groups. The majority of patients in study group were discharged within 24 h as compared to the routine discharge after 48 h.
CONCLUSION: Following ERAS principles in TLH results in decrease in post-operative nausea and vomiting, post-operative opioid requirement and hospital stay. Hence, the ERAS principles should be the standard practice in TLH even in a developing country setup.

INTRODUCTION

Surgical procedures elicit a 'surgical stress response’[1] which increases various cytokines, catabolic hormones, insulin resistance and activates coagulation cascade.[2] Reduction of stress due to surgery is of prime importance as it improves outcomes and reduces morbidity and mortality in the patient.[3] Kehlet and Wilmore first brought forth the multimodal intervention in the post-operative period which later led to enhanced recovery after surgery (ERAS) principles which covers the pre-operative, intra-operative and post-operative period.[4]

ERAS principles is an evidence-based surgical management approach that challenges traditional surgical practices and involves collaboration among members of the surgical team across various specialities. The main goal is to principally maintain normal physiology in the perioperative period.[5] The protocols subsume pre-operative patient counselling to deal with anxiety and expectations of the patient while curtailing overnight fasting and mechanical bowel preparation done traditionally before surgery. They entail nausea and vomiting prophylaxis with a focus on at least two antiemetics, preferable use of regional anaesthesia and multimodal analgesia which focuses on the use of non-steroidal anti-inflammatory drugs (NSAIDSs) and acetaminophen with lesser opioid use are recommended. They endorse maintenance of normothermia, perioperative euvolemia in form of zero fluid balance, Minimal invasive surgery, no drains, post-operative early oral intake, early catheter removal and early mobilisation with necessary thromboprophylaxis.[5678]

ERAS has been formerly studied in colorectal surgeries and proven to be beneficial.[910] It has also been studied and demonstrated benefits in various abdominal and vaginal gynaecological surgeries for benign and malignant conditions.[111213] Laparoscopy is in fact, itself an ERAS component that needs to be practiced whenever feasible.[14] However, very few studies have been conducted on the application of ERAS criteria in total laparoscopic hysterectomy (TLH) to date.[1516] We planned this study, applying ERAS principles to TLH with the aim to assess various ways in which the pre-operative, intra-operative and post-operative periods of these patients can be made comfortable and pain-free.

METHODS

In this non-randomised controlled study we enrolled all the patients undergoing TLH for various benign indications over the period of 1 year. We excluded the patients who did not give informed written consent for participation in the study, patients undergoing laparotomy, morbid obesity (body mass index [BMI] >30 kg/m2), coronary heart disease and those having uncontrolled diabetes (glycated haemoglobin >8.5). The patients were alternatively allocated to study and control groups. The study was approved by the local ethics committee (vide letter number-MEDIPULSE/20191103 Dated - 2 November 2019). The surgeries were performed by the same surgeon in a private healthcare setup in Jodhpur, Rajasthan, India. Inter-departmental coordination was ensured. The study group was the one in which ERAS principles were applied as below:

Pre-operatively patient counselling was done at the time of admission and patients were explained nature of surgery, anaesthesia and post-operative early meals, early mobilisation and early discharge. A full meal was given 6 h before surgery, 300 ml apple juice (carbohydrates rich drink) given 2 h before surgery, no mechanical bowel preparation done and 3rd generation cephalosporin antibiotic shot given 1 h before surgery. In the case of high-risk patients such as diabetes and obesity, antibiotic was changed to injectable amoxicillin + clavulanic acid. Anaemia was corrected pre-operatively and patients were taken up for surgery once haemoglobin >10 g/dL.

Intraoperatively, general anaesthesia with endotracheal intubation, 75 mg intramuscular diclofenac and 1 g intravenous (IV) paracetamol were given to cover multimodal analgesia. IV fluids were given at the rate of 2–4 ml/kg/h of ringer lactate, if hypotension occurred then colloid or vasopressor was given, normothermia was maintained by the use of warm blankets and warm fluids, injection dexamethasone and ondansetron were given to take care of nausea and vomiting and carbon dioxide insufflation pressures were kept at 12–14 mmHg.

Post-operatively patients were allowed liquids 2 h after the surgery. Solids were allowed and the catheter removed 6 h after surgery along with simultaneous patient mobilisation. IV fluids were omitted after 6 h, analgesia was given in form of acetaminophen and NSAIDS only, tramadol was given only if the patient was not relieved, injection ranitidine and ondansetron were given and injectable antibiotics continued for 24 h. Injection low molecular weight heparin (LMWH) was given according to the ACOG guidelines for the prevention of deep vein thrombosis and pulmonary embolism,[17] no mechanical compression devices were used and the patient was discharged within 24 h.

The control group was the one in which traditional care was given. This included:

Pre-operatively, overnight fasting was done, bowel preparation was done by laxative and 3rd generation cephalosporin antibiotic shot was given 1 h before surgery. Intraoperatively spinal as well as general anaesthesia with endotracheal intubation was given, no drug was given for nausea and vomiting and CO2 insufflation pressures were kept at 12–14 mmHg. Post-operatively the patient was allowed orally after 24 h and the catheter was removed at the same time. IV fluids were continued till that time. Post-operative analgesia was given in form of acetaminophen to all and tramadol was given to selected patients only. Injection ranitidine and ondansetron were given to all and LMWH given to high-risk group. The patient was discharged after 48 h of surgery.

The study group and controls were compared for various parameters which included post-operative pain, post-operative nausea and vomiting, the requirement of opioid analgesia, day of discharge and follow-up on day 7 to see for any urinary symptoms like burning micturition or increased frequency of micturition or any other complaint of the patient.

The post-operative abdominal pain was measured by a visual analogue scale of 0–10. Zero being no pain to 10 being the most severe pain possible. Post-operative pain abdomen was analysed at 6 h, 12 h and day 1 post-operatively and the median pain scores of two groups were compared. The patients were also assessed for overnight opioid analgesia (tramadol given intravenously) which was given only if the patient demanded. Post-operative nausea and vomiting reduction was compared. The patients were discharged after ensuring gut motility, patient pain-free, no nausea and vomiting and patient willing and confident for discharge.

Statistical analysis

The data were entered in excel sheet, checked for errors and statistical analysis was performed using SPSS version 25 (IBM, Armonk, NY, USA). Categorical variables were expressed as a number and a proportion (%) and the intergroup difference was tested using the Chi-square test. Continuous variables were expressed as median (95% confidence interval) and Mann–Whitney U-test was applied for analysis of difference. Two-tailed P < 0.05 was considered statistically significant.

RESULTS

A total of 103 patients underwent TLH were included in this study for 1 year, with 51 patients in the study group and 52 in the control group. The two groups were comparable for age, place of residence and BMI [Table 1]. The most common indication for TLH was abnormal uterine bleeding in both the groups, which included all the various causes that comes under PALM-COEIN classification.

Table 1

Demographic parameters

	Study group (n=51), n (%)	Control group (n=52), n (%)	P
Age (years)*	48 (47-51)	48 (48-51)	0.73
Residence
Rural (yes)	45 (88.23)	43 (82.69)	0.47
Urban (yes)	6 (11.76)	9 (17.31)	0.47
BMI (kg/m2)*	23.6 (23.2-24.4)	24.2 (23.8-24.6)	0.76
Indications
AUB (yes)	28 (54.9)	33 (63.46)	0.41
Fibroid uterus (yes)	19 (37.25)	14 (26.92)	0.27
Post-menopausal bleeding (yes)	2 (3.92)	4 (7.69)	0.39
Chronic PID (yes)	2 (3.92)	1 (1.96)	0.39
Surgical time (min)*	56 (55-62)	56 (54-61)	0.96

*All values are represented as median. Values in brackets represent 95% CI. CI: Confidence interval, BMI: Body mass index, AUB: Abnormal uterine bleeding, PID: Pelvic inflammatory disease

The post-operative pain assessed at 6 h, 12 h and day 1 was comparable in both the groups. Adequate analgesia was ensured in both groups. The requirement of opioid analgesia was significantly more in the control group (P < 0.001). Similarly, post-operative nausea and vomiting were also significantly more in the control group. Most patients developed post-operative nausea and vomiting on day 0 of surgery and it persisted in only 1 patient on day 1 in the study group and in 2 patients in the control group [Table 2].

Table 2

Post-operative parameters

	Study group (n=51), n (%)	Control group (n=52), n (%)	P
Pain abdomen (median pain score in a Scale of 0-10)*
After 6 h	8 (8-9)	7 (7-8)	0.1
After 12 h	3 (3-4)	3 (3-4)	0.20
Day 1	2 (2-4)	2 (2-3)	0.73
Opioid analgesia requirement (yes)	10 (20)	38 (76)	<0.00
Post-operative nausea and vomiting (yes)	4 (8)	13 (24)	<0.02
Average day of discharge
<24 h (day 1)	47 (92)	0	<0.00
>48 h (day 2)	3 (6)	45 (86)	<0.00
>72 h (day 3)	1 (2)	7 (14)	0.02
Urinary symptoms day 7 (yes)	6 (12)	10 (20)	0.27
Readmission (yes)	1 (2)	0	0.30

*All values are represented as median. Values in brackets represent 95% CI. CI: Confidence interval

In the study group, 47 patients were discharged within 24 h of surgery. Three patients on day 2 of surgery out of which 1 developed post-operative nausea and vomiting, 1 was not willing for an early discharge and 1 developed urinary retention. One patient was discharged on day 3 due to extensive adhesiolysis. In the control group, 45 patients were discharged on day 2 and 7 were discharged on day 3 (2 extensive adhesiolysis, 1 bowel resection, 1 urinary retention, 2 post-operative ileus and 1 post-operative nausea and vomiting). More patients in the control group had urinary complaints like burning micturition and increased frequency of micturition as compared to the study group but the results were not statistically significant. One patient in the study group required readmission for paralytic ileus whereas none in the control group required readmission [Table 2].

DISCUSSION

Substantial improvement in surgical outcomes is brought out by the use of advanced surgical modalities and better perioperative care.[18] In this study, the application of ERAS principles in TLH takes care of both the above parameters. The present study is conducted in a setup where most of the patients belong to rural background. The concept of hysterectomy in these areas of India is even today associated with a prolonged hospital stay and prolonged rest after surgery. Patients have to still be educated regarding laparoscopic surgery and early discharge. Same-day discharge after TLH which is the new normal in the developed world will still take time in the universal application,[19] especially in the developing and underdeveloped countries.

ERAS protocols apply to the quality rather than the speed of recovery.[20] The role of ERAS in shortening the hospital stay and hence the hospital costs is well established in various gynaecological and non-gynaecological surgeries. In the present study majority of the patients were discharged within 24 h of the surgery after ERAS protocol application as opposed to the traditional practice of 2 day hospital stay. There was a reduction in opioid requirement and post-operative nausea and vomiting as compared to the control group. Overall the post-operative period of patients was comfortable and patients were willing for an early discharge after implementation of ERAS protocols. The role of pre-operative counselling was of utmost importance as patients were mentally prepared for an early discharge and early resumption of activity as opposed to their traditional beliefs.

Opioids have a notorious side effect profile with acute post-operative side effects in the form of constipation, decreased bowel motility, ileus, nausea and vomiting, sedation and delirium.[21] Opioid-free analgesia lessens opioid exposure and hence reduces opioid tolerance and later on opioid dependence. Opioid-free analgesia is, therefore, an important component of ERAS as it enables early feeding and early discharge from hospital in addition to a possible long-term role in dealing with the opioid dependence epidemic.[22]

A study by Lee et al.[15] compared ERAS between laparotomy and laparoscopy group and showed better mobilisation and early discharge of patients in both the groups. ERAS has been applied in gynae-oncology patients undergoing minimally invasive surgery by Chapman et al.[23] Besides decreasing hospital stay, better pain scores with less opioid use and decreased hospital costs have been observed in this study. A randomised control trial has shown decreased hospital stay in gynaecologic surgeries in laparotomy and laparoscopy groups as compared to controls. This study also showed decreased fluid requirement and improved pain score after ERAS implementation.[16] Keil et al.[24] studied the predictors of prolonged admission in patients undergoing minimally invasive gynaecologic surgery after ERAS implementation. They removed urinary catheter immediately post-operatively and discharged the patients from post-anaesthesia care unit. Those requiring prolonged admission were not discharged due to urinary retention, inadequate pain control, post-operative nausea and vomiting, extensive adhesiolysis, bowel resection, haematoma formation or haemodynamic instability. In our study, the catheter was removed after 6 h and only one patient required re-catherisation. Forty-seven patients were discharged within 24 h, 3 patients were discharged on day 2 (1 due to retention of urine, 1 post-operative nausea and vomiting and 1 was not willing to go) and 1 patient on day 3 due to extensive adhesiolysis.

The readmission rates in the present study were not affected by ERAS implementation as they were not significant in both groups. This has been observed by Sheyn et al.[19] and Keil et al.[24] also. Early discharge does not lead to increased rates of readmission in patients undergoing TLH for benign indications. In the follow-up, there was no major difference between both groups. The advantage of ERAS was only observed in the immediate post-operative period which is significant as it improves patient satisfaction and also decreases the patient burden on the health infrastructure as it promotes early discharge in the majority of patients.

The strength of this study is that it is the only study conducted in a developing country which studies the implementation of ERAS in TLH. It aims to study the feasibility of early discharge in these patients’ along with decrease in post-operative morbidity. The main limitation of this study is that, being a small sample size study the results may not be accurate for different populations. More such studies are required with a larger sample size and multiple different centres so that ERAS in TLH becomes the new normal even in developing countries.

CONCLUSION

ERAS principles are a practical scientific tool for improving perioperative care in TLH. However, ERAS being a new concept is a major factor in reluctance and different acceptability among surgeons who prefer to follow the long-ingrained traditional protocols. This study reinforces the fact that erudite compliance with ERAS protocols in developing countries definitely improves surgical outcomes.

Financial support and sponsorship

Nil.

Conflicts of interest

There are no conflicts of interest.