Intra- and post-operative outcomes in benign gynaecologic surgeries before and after the implementation of enhanced recovery after surgery protocols: A comparison.

Enhanced recovery after surgery (ERAS) was first introduced in 1997 by a group of surgeons from Northern Europe led by Henrik Kehlet, as a model of health care in colorectal surgery. It is a compilation of evidence-based, best practice guidelines in the peri-operative period to mitigate the physiologic stress response to surgery and promote recovery. It requires multidisciplinary teamwork. In 2010, ERAS society was officially created and registered in Sweden as an International Non-profit Medical Academy Society. Since then, ERAS has been extended to different surgical streams.[ 1 ] The body responds to surgical stress by catabolism and endocrine responses such as gluconeogenesis, cortisol production and insulin resistance. In addition, there are increased cardiac output, relative tissue hypoxia, deranged coagulation profile and altered pulmonary and gastroenterology function. These can be reduced by good pain relief, avoiding prolonged fasting and use of carbohydrates loading. ERAS protocols help maintain normal physiology. Conventionally, surgical patients are prepared with mechanical bowel preparation, nothing by the mouth after midnight, patient-controlled analgesia with liberal use of narcotics, prolonged bowel and bed rest, use of nasogastric tubes and drains and slow reintroduction of feeding. There is no evidence to support that these practices help, rather their use hinders healing and recovery. The key components of ERAS are pre-operative counselling involving detailed sessions which involve risk stratification, surgery plan and probable length of stay. There is no benefit observed in mechanical bowel preparation and it is not indicated before benign gynaecological surgery.[ 2 ] Dehydration is avoided by reducing the pre-operative starvation of fluids and solids. Multimodal anti-emetics and analgesics are used to combat post-operative pain, nausea and vomiting. Non-steroidal analgesia is recommended and opioids are discouraged. Intraoperative euvolaemia and normothermia are to be maintained. The use of surgical tubes, drains and vaginal packs is minimised. ERAS protocols encourage early ambulation and thromboprophylaxis in every patient. Intravenous (IV) fluids are discontinued within 24 h and oral fluids are started within 4 h and solid diet by 6 h of surgery. Once mobilised, if a woman is able to tolerate solids without nausea and vomiting and is on oral analgesics, she can be discharged. Flatus is not necessary for discharge.[ 3 ] A prospective online survey using SurveyMonkey was done globally and responses were obtained from practitioners from 62 countries. Overall, 42% of practitioners felt that ERAS protocols are a useful tool but ‘difficult to implement,’ and 45% of practitioners felt that ERAS protocols decrease both unscheduled hospital visits and readmission rates.[ 4 ] With the COVID-19 pandemic and overstretched health-care systems, ERAS protocols are even more relevant today than before. Patients managed with ERAS protocols can leave hospitals early, allowing for hospital resources to be focused on those who need it most during this time of global need.[ 5 ] The aim of this study was to compare the effects of ERAS protocol implementation in women undergoing minimal invasive surgery for benign gynaecologic indications in terms of surgical outcome and immediate post-operative complications with women who did not receive these protocols.

A total of 204 patients were included, in which pre-ERAS group had 100 patients and ERAS group had 104 patients. The mean age of ERAS group was 42.5 years and that of pre-ERAS was 41.46 years. Demographic profiles of both the groups were comparable. Both the groups did not differ much in age ( P = 0.39), BMI ( P = 0.63), pre-operative haemoglobin ( P = 0.85) and parity or ASA score. Surgeries included were hysterectomies and myomectomies only, 74 hysterectomies and 30 myomectomies in the ERAS group and 58 hysterectomies and 42 myomectomies in the pre-ERAS group. Demographic profiles [ Table 1 ] of both the groups were comparable including age, BMI, ASA score, pre-operative haemoglobin, parity and previous abdominal surgeries. ERAS group had more hypertension ( P = 0.045) and more incidence of the previous caesarean section ( P = 0.010). The difference was also observed in the diagnosis. In the pre-ERAS group, 92% of patients were operated for fibroid uterus, whereas in the ERAS group, in addition to fibroid, shift is seen towards adenomyosis and endometriosis. This difference can be attributed to the inclusion of more complex cases with the passing years. Pre-operative data Data are the mean±SD or n (%) unless otherwise specified. ERAS: Enhanced recovery after surgery, BMI: Body mass index, ASA: American Society of Anesthesiologists, LSCS: Lower segment caesarean section, SD: Standard deviation Intraoperative data are shown in Table 2 . Average duration of surgery was more in the ERAS group (129.12 ± 80.85 min) as compared to 123.7 ± 59.25 min in the pre-ERAS group, but the difference was not statistically significant ( P = 0.59). Blood loss was less in the ERAS group (200.85 ± 334.30 ml) versus (277.17 ml ± 403.82) with ( P = 0.22) but was not significant. Weight of the specimen in both the groups was similar, 339.69 ± 353.73 g in the ERAS group versus 337.38 ± 280.49 g in the pre-ERAS group. We encountered intraoperative adhesions in similar numbers of cases in both the groups (54.80% patients in the ERAS and 44% in the pre-ERAS group). Time taken to remove Foley’s catheter ( P = 0.023) and ambulation ( P = 0.007) was significantly lesser in the ERAS group when compared to the pre-ERAS group. Peri-operative data Data are the mean±SD or n (%) unless otherwise specified. TLH: Total laparoscopic hysterectomy, RH: Robotic hysterectomy, LM: Laparoscopic myomectomy, RM: Robotic myomectomy, VH: Vaginal hysterectomy, TAH: Total abdominal hysterectomy, SD: Standard deviation, ERAS: Enhanced recovery after surgery Time to intake of oral liquids after surgery ( P < 0.001), time to eating of solid food ( P < 0.001), time to passage of first flatus ( P < 0.001) and length of stay in hospital after surgery ( P < 0.001) were all significantly less in the ERAS group when compared to the pre-ERAS group. Significant difference was seen in use of intraperitoneal drains which were used in 81% women in the pre-ERAS group and in only 23.1% in ERAS cases ( P < 0.001). When used, drains were removed early in the ERAS group, 66.66% were removed within 40 h whereas in pre-ERAS group drains continued for a long time, only 28.39% removed in <40 h. Route of administration of drugs in the immediate post-operative period, of antibiotics, analgesics and antacids was oral in only 4% in pre-ERAS patients while 56.73% in the ERAS group. This difference was statistically significant ( P < 0.001). Pain score (VAS) was found lesser in the ERAS group ( P = 0.001). Post-operative results are tabulated in Table 3 . Post-operative results Data are the mean±SD or n (%) unless otherwise specified. VAS: Visual Analogue Scale, ERAS: Enhanced recovery after surgery, SD: Standard deviation, IV: Intravenous Regarding the intraoperative complications, one patient in each group had serosal injury of bowel when doing adhesiolysis, while one in each group had bladder injury, which was repaired during surgery. One patient had intractable haemorrhage in the ERAS group, for which surgery was converted to laparotomy and completed. Ten patients in the ERAS group and 13 patients in the pre-ERAS required blood transfusion. Intra- and post-operative complications are given in Table 4 . Post-operative mild-to-moderate fever was noticed in 7.69% of patients in the ERAS group and 6% in the pre-ERAS group. Twenty-four patients had post-operative vomiting in the ERAS group versus 28 patients in the pre-ERAS group, but the difference was not statistically significant. Only 12.5% of patients required medication for vomiting in the ERAS group compared to 20% in the pre-ERAS group. Urinary complaints such as burning micturition, retention of urine and re-catheterisation were seen in 3.8% of patients in the ERAS group compared to 8% in the pre-ERAS group. 17.3% of ERAS patients had post-operative spotting compared to 9% in pre-ERAS. Only 2.9% of patients had bleeding significant enough requiring medication in the ERAS group, whereas 5% of patients required the same in the pre-ERAS group. Abdominal discomfort was more in pre-ERAS than ERAS patients, which was a significant difference ( P < 0.005). Intra- and post-operative complications Data are the n (%) unless otherwise specified. ERAS: Enhanced recovery after surgery

ERAS is an important scientific tool with a comprehensive bundle of interventions in reducing the length of stay with early feeding, early ambulation, less pain, more rapid return of bowel function, without an increase in complications.[ 28 ] It is still followed in very few institutions, especially in developing countries like India. Many surgeons are still unaware of these protocols, and even if known, reluctant in its acceptance and implementation. Teamwork is essential for its successful implementation. It took us 3 years in our unit to fully implement, but when done, it significantly reduced time taken for oral feeds (liquids and solids), time to pass flatus, use of intraperitoneal drains, pain scores and length of hospital stay. Universal standardisation of the protocols is required, so that protocols can be followed with ease without any confusion. Although the results of this retrospective study favour the implementation of ERAS in routine clinical surgical practice, the authors recommended performing multicentric randomised control trials on the subject. The strength of this study is in the completeness of our data. Pre-operatively, both the groups were comparable in demographic and operative variables. It is a single-centre study with all the surgeries performed by a single surgeon reflecting consistency. However, not being a randomised controlled trial is the biggest limitation of the study. We could not perform a blinded study, as all the elements involved cannot be blinded. A gap of 3 years was kept in patient selection as a transition period in the implementation of ERAS program fully, but this could have influenced certain variables in the study. Nil. There are no conflicts of interest.

ERAS protocols have been implemented in specialties such as colorectal, vascular and thoracic surgeries for more than two decades. Over the period, it has been accepted as a scientific evidence-based program in the field of gynaecology too. ERAS guidelines have been updated in gynaecologic oncology in 2019.[ 6 ] These interventions are supported by data in decreasing surgical stress or helping the body mitigate the negative consequences of such stress.[ 7 ] Minimal invasive surgery is an important aspect of ERAS as surgical stress responses such as inflammatory, immunomodulatory and cortisol stress responses are less, translating to better post-operative outcomes. There are less intraoperative blood loss, early return of bowel function and shorter hospital stay. In our study, most surgeries in both the groups were by minimal invasive method, mainly laparoscopic and robotic. However, two cases of vaginal hysterectomy and four abdominal hysterectomies were included in the pre-ERAS group. The ERAS group had five vaginal hysterectomies with no abdominal hysterectomy. Minimally invasive surgery for benign surgeries is associated with decreased complications, surgical site infections, risk of venous thromboembolism and shorter hospital stay and with improved quality of life as skin incisions lead to pain, inflammation and catabolism. Optimisation of haemoglobin and the associated comorbidities were done before surgery in both the groups. Pre-operative haemoglobin in both the groups was comparable. For elective surgery, target haemoglobin recommended is more than 12 mg%.[ 8 ] Anxious patients are more likely to have pain after hysterectomy either acute or chronic.[ 9 ] Pre-operative detailed counselling gives patients’ realistic expectations and subsequent response to the surgery. These then translate to their reduced anxiety and worry leading to less analgesia requirement. This correlates with our findings as patients of ERAS group had significantly ( P < 0.001) less pain than pre-ERAS group with an average post-operative VAS score 5.69 ± 1.72 versus 6.4 ± 1.23, respectively. Zhao et al .[ 10 ] and Charles et al .[ 11 ] also confirm that patient counselling is an important component of ERAS protocols and contributes to early recovery and to less analgesia requirement when compared to patients who are uninformed. In this study, we did not use the mechanical bowel preparation unless suspected to have high incidence of dense bowel adhesions due to previous surgery or pathology. This is in concurrence with multiple publications that suggest that whether the procedure is laparoscopy, robotic or vaginal mechanical bowel preparation does not offer any advantage in visualisation of surgical field, surgical site infection rates or length of stay. In fact, adverse physiologic effects experienced by the patients are significantly higher when oral laxatives are used.[ 12 , 13 ] Delaying oral feeds after abdominopelvic surgeries are more of a norm than exception without any scientific evidence. At present, strong evidence supports early feeding. It maintains mucosal integrity and function of the gut with a positive nitrogen balance. Early post-operative oral intake results in a decreased length of hospitalisation and is well tolerated when compared with traditional dietary management in patients undergoing abdominal surgery.[ 14 ] We achieved an intake of liquids in 4.25 h and that of solids in 8.09 h in the ERAS group, a significant difference in post-operative diet intake when compared to the pre-ERAS group. This translated in significant reduction in the length of stay in the ERAS group (36.24 ± 22.57 h) as compared pre-ERAS group (59.97 ± 28.98 h) in our study. This also concurs with Massimiliano et al . who reported that post-operative enteral feeding is harmless even with colorectal anastomosis.[ 15 ] Early ambulation is one of the key elements of ERAS, and it decreases risk of thromboembolism, improves bowel functions, prevents loss of muscle mass and decreases insulin resistance.[ 16 ] It also reduces stress and ensures return to work at the earliest. We found a significant difference in the ambulation time between the two groups: the ERAS group had earlier ambulation when compared to the pre-ERAS group. It has been observed that the removal of catheter after surgery is not associated with any increased chances of re-catheterisation, but there is a benefit of decreased risk of UTI.[ 11 ] We were able to remove catheter <24 h after surgery in the ERAS group. Passage of flatus is a sign of gut motility. Many surgeons feed the patient after seeing the resumption of gut activity and flatus is one of them. On the contrary, we started early feeding and noticed that it helped our patients in restoring bowel function and passage of early flatus. Elgohary et al . showed similar results and they found that ERAS group had a shorter time to pass flatus (55% vs. 20% in the 1 st post-operative day).[ 17 ] In ERAS, pain management starts before first incision, and pain receptors are blocked before they are activated. For pain management, we used a multimodal approach avoiding opioids, using NSAIDS and paracetamol. Both have different modes of action. We used mainly oral medications in the ERAS group and the VAS score was significantly reduced. Cain et al . did not find any difference in post-operative opioid consumption between patients receiving pre-operative IV or oral acetaminophen within an ERAS programme for patients undergoing open gynaecologic oncology surgery.[ 18 ] A randomised controlled trial also found less pain score with ERAS patients, 3.25 ± 0.9 versus 3.8 ± 1.1 in controls ( P = 0.0024).[ 19 ] Another study corroborated similar findings.[ 17 ] In our study, pain score (VAS) was found significantly lesser in the ERAS group ( P < 0.001) as compared to the pre-ERAS group. Gynaecologists use intraperitoneal drains to decrease fluid collections or as a surrogate marker to diagnose intra-abdominal bleeding in the post-operative period. In fact, drains act as a source of pain and sometimes invite infection from the skin to the abdominal cavity. It interferes with mobilisation, which is the mainstay for the success of ERAS. We avoided intraperitoneal drain in about 75% of our patients in the ERAS group as compared to 20% in the pre-ERAS group. Liang et al . reported that drainage can be avoided or restricted to a small period, helping quick mobilisation.[ 20 ] Length of stay measures the quality of care given in a health-care institution. We can achieve early discharge by holistic multimodal approach. Length of stay decreased significantly in the ERAS group (36.24 ± 22.57 h) as compared to the pre-ERAS group (59.97 ± 28.98 h), which was the major positive outcome of our study. ERAS has succeeded in decreasing hospital length of stay as corroborated in different studies.[ 17 , 21 , 22 ] Bisch et al . found that in medium/high complexity surgery, the median length of stay was reduced by 2 days ( P = 0.0005).[ 23 ] No major difference in intraoperative complications was seen with one bowel and one bladder injury noted in each group. No significant difference was seen in post-operative fever, urinary complications, vomiting and post-operative vaginal bleeding in both the groups. Gulseren et al . studied 30 patients with ERAS protocols and compared with 32 who received conventional perioperative care; they observed no significant difference in complications seen. 30% of patients in the ERAS group and 35.7% in the conventional group suffered from complications.[ 24 ] Susan et al . found the rate of complication decrease from 40% to 21% ( P < 0.001) after implementing ERAS specifically related to higher rate of transfusion or bleeding (19% compared to 4%, P < 0.001) in the pre-ERAS group.[ 22 ] There was no readmission in 30 days in both the groups in our study. In a study by Bisch et al. , the ERAS group complications decreased from 53.3% to 36.2% ( P = 0.0003). Both the groups had no significant difference in readmission ( P = 0.6159), complications up to 30 days ( P = 0.6274) or mortality ( P = 0.3618).[ 23 ] The rate of readmission for laparoscopic surgery is reported as 0%–7%.[ 25 – 27 ]

We conducted a cohort study on women who underwent surgeries for benign gynaecologic indications in a tertiary care institution, before and after the implementation of ERAS program. Surgeries included were hysterectomies and myomectomies only by laparoscopic, robotic and vaginal approach and a few by abdominal route. In the first group, 100 women underwent the above-mentioned gynaecological surgeries before the implementation of ERAS protocols, from March 2017 to January 2018, and were classified as pre-ERAS group. In the second group, 104 women were included after the implementation of ERAS programme, who had undergone the above-mentioned surgeries from October 2020 to September 2021, assigned as ERAS group. The gap of 3 years was kept between the two study groups as this period was transition in the implementation of ERAS programme. Patients in both the groups were matched for age, body mass index parity and American Society of Anesthesiologists (ASA) score. All patients underwent surgery by the same surgeon. Patients with malignant indications, planned laparotomies, surgeries performed other than hysterectomies and myomectomies and day care surgery patients were excluded. Traditional care in the pre-ERAS group did not have any goal-oriented counselling. Fasting from the midnight was advised irrespective of the time of surgery the next day. Tablet bisacodyl was advised orally the night before surgery for bowel movement. There was prolonged fasting after surgery, and oral feed was started after confirming bowel sounds. Removal of the catheter followed by mobilisation of the patients was done the next morning. Drains were freely used when the need was felt. All patients received IV medications in the immediate post-operative period, which included antimicrobials, analgesics, antacids and anti-emetics. All patients received thromboprophylaxis with low-molecular-weight heparin starting 8 h after surgery (dalteparin sodium 2500 IU subcutaneously once a day). Patients were discharged when there was no remaining line or catheter, solid food was tolerated and flatus or stools were passed. Patients were put on oral medications before discharge including oral analgesics. ERAS implementation involved the primary surgical team, anaesthesiologist and the nurses who were explained the protocols and were sensitised to the benefits of these. It started with detailed counselling of patients and caregivers regarding the procedure, associated risks and expected post-operative care. Most important was involving the patients actively in their recovery process, which includes early ambulation, early feeding and well-explained discharge criteria, so that the programme can be implemented successfully. Pre-operative prolonged fasting was avoided by allowing a soft diet up to 6 h and clear liquids up to 2–3 h before surgery. No mechanical bowel preparation was advised. Two tablets of tablet bisacodyl were given orally the night before surgery. During anaesthesia, multimodal analgesia with the use of short-acting anaesthetic agents was given avoiding opioids. Agents used were injection fentanyl 100 mcg, injection propofol 100 mg and injection cisatracurium 10 mg. For reversal, injection neostigmine 3 mg and injection glycopyrrolate 0.6 mg were given. Intraoperatively, injection ondansetron 8 mg along with injection dexamethasone 8 mg was given as anti-emetics. Dexamethasone has anti-emetic as well as anti-inflammatory effects. Injection diclofenac 75 mg and injection paracetamol 1 g were given before reversal of anaesthesia. Euvolaemia and normothermia were maintained throughout the procedure. The use of drains was refrained. Skin wound was infiltrated with local anaesthetic agent 0.25% bupivacaine, 4 mg/kg at the time of skin closure. For thromboprophylaxis, low-molecular-weight heparin (dalteparin sodium 2500 IU subcutaneously once a day) was started 8 h after surgery. First-generation cephalosporins were given IV as infection prophylaxis at induction. A repeat dose of antibiotic was given if the patient had comorbidities such as diabetes and blood loss more than 1 l or if surgery took more than 3 h. All patients received oral medication including antibiotics, analgesics and antacids in the immediate post-operative period. Early intake of liquids was encouraged by 3–4 h followed by a soft diet in 6 h. IV fluids were discontinued the next morning. Catheters were removed in <24 h and simultaneously ambulation encouraged within 24 h. The next day morning, the pain score was assessed on a Visual Analogue Scale (VAS) ranging from 0 (no pain) to 10 (worst imaginable pain). For pain relief, oral paracetamol and non-steroidal anti-inflammatory drugs (NSAIDs) were used, and opioids were avoided. Our ERAS protocol has been depicted in the flow chart [ Figure 1 ]. Both the groups were compared in terms of age, parity, body mass index (BMI), pre-operative haemoglobin, comorbidities, previous surgeries, indication and type of surgery, weight of specimen, duration of surgery, blood loss, use of intra-abdominal drain, time of starting of oral feeds, ambulation, catheter removal, time taken to pass first flatus, intra- and post-operative complications and length of stay. All the collected data were collected in Microsoft Excel and analysed using the SPSS statistical software suite developed by IBM for data management, advanced analytics, multivariate analysis SPSS version 26.0 for Windows (SPSS Inc., Chicago, IL, USA). The qualitative variables were reported as proportions, whereas the quantitative variables were reported as mean ± standard deviation. The significance between the cases and controls for quantitative variables was tested using the independent t -test, and Chi-square test was used for the evaluation of association for qualitative variables. P < 0.05 was considered statistically significant. All P values were two-tailed. ERAS protocol at our unit in Gynecology department at Apollo Hospital, Hyderabad