European Journal of Cardiovascular Medicine

A loop ileostomy has been utilized widely in elective colorectal surgery to protect a very low rectal anastomosis such as following a TME or restorative proctocolectomy, which are considered high leak risk anastomoses, as well as for diversion purposes following emergency surgical procedures. Ileostomy construction has been shown to dampen the clinical effects of a leak as well as to reduce the rate of intervention post leakage (1,2). However, the benefits of the covering ileostomy have to be weighed against the problems associated with its closure.

The most commonly reported complications after ileostomy closure include bowel obstruction, surgical site infection, anastomotic leaks, fistulae formation and incisional hernia formation (3)-(9). Although it is considered to be a routine operation, closure of ileostomy is associated with significant morbidity. Furthermore, it requires another hospital admission, and also utilizes the same if not more resources post operatively than the primary procedure necessitating its formation (1).

The aim of this study was to document the incidence of and identify risk factors for postoperative complications after loop ileostomy closure at of Bhopal Memorial Hospital & Research Centre, Bhopal Madhya Pradesh.

The study was approved by the Human Research Ethics Committee of the Faculty of   Bhopal Memorial Hospital & Research Centre, Bhopal Madhya Pradesh. All patients who were admitted for closure of ileostomy to the colorectal unit at Bhopal Memorial Hospital & Research Centre, Bhopal Madhya Pradesh from January 2022 to January 2023 were included in the study.

Individual patient medical, anaesthetic and nursing records were reviewed to extract information retrospectively. Inclusion criteria were all patients with previous loop ileostomy constructed during both elective and emergency surgery during the above time period.

The following information was extracted from the patient records: patient demographics, indication for ileostomy, comorbidity status, BMI, length of hospital stay, duration of stoma, time taken to achieve bowel movement after closure, performance status of the patient, administration of preoperative chemotherapy or radiotherapy or both, experience level of surgeon performing the operation (junior consultant or registrar), duration of the surgery, type of anastomosis performed (hand sewn or stapled) and whether the patient required re-operation or not.

The complications observed were divided into 3 main groups, major, minor and medical complications. The major complications included the occurrence of SBO, anastomotic leaks, fistulae, hernia and stricture. Minor complications included surgical site infection, bleeding per rectum and occurrence of a stitch granuloma. Medical complications included pneumonia, UTI, line sepsis, cardiac complications, renal failure, anaemia, DVT and allergic reaction to medication. The frequency of these complications was then recorded for each patient.

The 30 day outcomes of the patients was graded from I-IV using the Clavien-Dindo scoring system (See appendix 1).

(i)           Surgical Technique

All patients had a radiological contrast study (loopogram) done prior to closure to rule out any distal bowel obstruction and leaks. The patients did not receive any bowel preparation prior to closure.

At the operation all patients received a single dose of prophylactic antibiotics (Cefazolin 1g IV) about 30 minutes prior to the skin incision. A peristomal skin incision was used and none of the patients needed a laparotomy for the closure. Standard loop ileostomy closure was performed using either a single layer hand sewn end to end anastomosis with vicryl 2/0 absorbable suture or a functional end to end anastomosis with a 60mm linear GIA stapler.

All operations were performed either by a registrar under the supervision of a junior consultant, or by a junior consultant with a registrar as the first assistant.

(ii)          Data Analysis

All the data was entered into an Excel data work sheet directly. The data was then coded and double entered into a statistical software package (Stata version 12.1) for analysis. Descriptive statistics were utilized to analyses the data. The chi squared test and its variants, Student’s t- test and logistic regression was used to analyses the variables and their outcomes.

There were 88 patients who underwent closure of ileostomy between January 2008  and December 2012. The data was incomplete in eight patients and they were excluded from the data analysis.

Of the remaining 80 patients 45 patients were male and 35 were female with a mean age of 50.6 ± 15.7 years (range 18-81 years).

Majority of the patients were of mixed-race origin (n= 51). Sixteen patients were white, 11 were black and 2 were of Indian origin. Only 43 of the 80 patients had BMI recorded. The mean BMI was 26 with a median of 25.64 (range 7-40.64). The patient characteristics are summarized in Table 1.

Table 1: Patient characteristics

Eight (10%) patients had diabetes, 25 (31.25%) had hypertension, and 28 (35%) had renal dysfunction (creatinine raised to 1.5 times of baseline levels). There were 42 patients who smoked and 2 were on immunosuppressive therapy.

Fifteen were ASA I, 45 patients were ASA class II and 20 patients were ASA class III.

The most common indication for loop ileostomy formation was following a TME for rectal cancer (51%) as shown in Figure 1. Other primary indications for ileostomy formation included ulcerative colitis (18%), Crohn’s disease (9%), diverticular disease (6%), intra-abdominal sepsis (5%), FAP (5%), RVF (3%), tuberculosis (1%) and following a traditional enema (1%).

Figure 1: Duration of Ileostomy prior to closure

The duration of the ileostomy prior to closure is shown in Figure 2. The mean duration of ileostomy prior to closure was 8.23 ±4.42 months, with a median of 7 months (range 2-24months). This long duration is due to the prolonged waiting time in a resource stretched hospital.

Forty two (52%) of the operations were performed by registrars while 38(48%) were performed by junior consultants.

The majority of the anastomoses performed were hand sewn (n=71, 89%), and only 9 (11%) were stapled anastomoses.

The duration of the surgery is shown in Figure 3. The duration of surgery varied from 30 to 183 minutes with a mean of 86 ± 32.76 minutes. The duration of the surgery did not correlate with the development of complications (p= 0.58, OR=1.0, CI= 0.99 to 1.02).

Figure 2: Duration of the surgery

The mean length of hospital stay was 7.04 ± 6.57 days with a maximum duration of stay of 37 days in one patient who had recurrent episodes of bowel obstruction postoperatively.

The median time to achieve bowel movement was 3 days (range 2-16 days). One patient took 16 days to open bowels, while one patient had missing data. First bowel    movements occurred mostly between days 1 and 5. Fewer bowel movements occurred between days 6 and 10.

Complications

Two patients died post ileostomy closure (See Figure 4). Overall, 38 (47.5%) patients developed complications post closure of ileostomy (See Table 2). Major complications accounted for a large proportion of complications (n=28), while minor (n=18) and medical complications (n=17) were less common. More than half (52.6%) of the complications were seen in patients with rectal cancer while 6 of the 7 patients with Crohn’s disease developed complications. Patients with sepsis, RVF, PJS and traditional enemas did not develop any complications (See Table 2) but rectal cancer was the most common indication for surgery so the denominator is made up of these patients (41/80).

Table 2: Complications post ileostomy closure

1. Major complications

Major complications were seen in 28 (35%) patients (see Table 2). The major complications included SBO (n=11, 14%), enterocutaneous fistula (n=5, 6%), incisional hernia (n=3, 4%), stricture (n=1, 1%). Ten percent of the patients had multiple major complications. One patient developed an anastomotic leak, after developing an enterocutaneous fistula and stricture 4 weeks post closure.

1. Minor complications

Minor complications occurred in 18 (25%) patients. Of the minor complications noted, 21% (n=17) had wound infection, one patient had bleeding per rectum, one patient had constipation and three patients had stitch granulomas which needed excision. Only one patient had multiple minor complications.

1. Medical complications

Medical complications were seen in 17 (21%) patients and included pneumonia (n=5, 6%), UTI (n=3, 4%), line sepsis (n=2, 3%), anaemia (n=1, 1%) cardiac complications (n=1, 1%), DVT (n=1, 1%) and allergic reaction (n=1, 1%). Three (4%) patients had multiple medical complications.

1. Deaths

Two patients died of medical complications. One died on day 17 of ventilator associated pneumonia and the other on day 43 of complications of recurrent DVT. The types of complications are summarized in Figure 5.

Figure 3: Types of complications post ileostomy closure

The reoperation rate was 11.25% (n=9). The indications for reoperation were stitch granulomas (n=3), incisional hernias (n=2), enterocutaneous fistula (n=1), relook for suspected leaks (n=2) and incision and drainage of an abscess in the wound (n=1).

The 30 day Clavien-Dindo grading system classified fifty seven (71%) patients into Grade I, 15 (19%) into grade III and 6 (7.50%) into grade IV.

Factors associated with development of complications

Twenty percent (n=16) of the patients received adjuvant chemotherapy between their rectal excision and ileostomy closure. Twenty one percent (n=17) had received preoperative radiotherapy prior to the rectal excision for which the ileostomy was created. The use of preoperative chemotherapy and preoperative radiotherapy did not correlate with the development of complications in the rectal cancer group of patients.

Univariate analysis of potential risk factors associated with development of complications showed that renal dysfunction was the only factor which was a statistically significant determinant of the development of complications (OR=3.38 p=0.014, 95% CI 1.280-8.911) (See Table 3).

Table 3: Univariate analysis

Multivariate analysis of risk factors was performed using a forward stepwise logistic regression model. The analysis was adjusted for confounders which included age, gender, performance status, duration of ileostomy prior to closure, duration of surgery, ethnicity and annual income. Other variables which were entered into the stepwise logistic regression model were smoking, diabetes, hypertension, renal dysfunction, type of closure, surgeon, and pathology.

Renal dysfunction was found to be a statistically significant determinant for the development of complications (OR=3.31, p=0.022, 95%CI=1.186 to 9.242) (See Table 4).

Table 4: Multivariate analysis

Risk Factors for development of Major Complications

Thirteen out of 28 patients with renal dysfunction developed major complications. However, renal dysfunction was not a statistically significant risk factor for the development of major complications on univariate (OR =2.14, P-value= 0.119, 95% CI= 0.823 to 5.55) and multivariate analysis (OR= 3.60, P-value= 0.224, 95% CI=

0.46 to 28.46).

Although closure of ileostomy is regarded as a relatively minor surgical procedure, it does require a second hospital admission which is accompanied by considerable costs, and is associated with significant morbidity (1).

In this study almost half the patients (47.5%) developed a complication which is much higher than that quoted in the literature. The mortality rate was 2.5% which is within the reported range. Of the two patients who died of medical complications, one had rectal cancer and the other FAP and both were elderly males, with renal dysfunction and a poor performance status prior to closure. Most of the data regarding complications following ileostomy closure comes from a small number of reviews done in USA, Spain, Turkey and Europe reflecting a morbidity of 3-30% and a mortality rate of 0-4% (3), (4), (5), (10), (11). A recent study on 5,401 patients demonstrated a complication rate of 9.3% and a mortality rate of 0.6% (1).

The indications for the ileostomy closure in this study included a mixture of patients with both rectal cancer and inflammatory bowel disease mainly. Almost all (six out of seven) of the patients with Crohn’s disease and almost half (six out of fourteen) of the patients with ulcerative colitis developed complications. This could be one of the reasons for the overall high complication rate observed.

However, on comparison of the individual complication types with that reported in literature, most complications fall within the expected reported range.

In the present study, SBO occurred in 14% of patients, and is reported as 0-15% in the literature (12). The anastomotic leak rate in this study was interestingly low (1 patient, 1%) and occurred as part of multiple major complications. In the literature the anastomotic leak rate alone varies between 0- 8% (12). The enterocutaneous fistula rate of 6% in the present study was also in accordance with that reported (0.5- 7%) (12).The rate of incisional hernia development was 4% and falls within the reported range of 1-12% (9), (12). The time taken for the hernia to develop in this study ranged from 3-17 months post ileostomy take down.

The rate of surgical site infection of 21%, was higher than that reported in literature (18.3%) (12). This could possibly be explained by poor wound care related to patients having a higher threshold to come to hospital for follow up postoperatively due to financial constraints or long travelling distances. Most of our patients were of lower socioeconomic status. Another problem is the inadequate wound care provided at local clinics within the patient’s home area.

The reoperation rate in this study was 11% which is much higher than that reported in the literature (6-8%) (5), (13).

In an attempt to identify any possible risk factors which may have contributed to this high complication rate, univariate and multivariate analysis were performed. Renal dysfunction was the only identifiable factor found on both univariate and multivariate analysis to be associated with a high complication rate. This is in keeping with the findings of Sharma et al who described a 2.5 times risk of developing major complications in patients with renal dysfunction (1). However renal dysfunction was not a statistically significant determinant for the development of major complications. This could possibly be due to the small sample size or the fact that there were too many variables and few major complications.

Patient factors such as age, gender, performance status, ethnicity, hypertension, diabetes, pathology and annual income did not influence the development of complications. Perioperative factors such as experience level of the surgeon, type of closure and duration of surgery did not contribute to development of complications. This is in keeping with the literature (1), (14), (15), (16).Pre-operative radiotherapy and chemotherapy also did not influence the development of complications in the rectal cancer group, which has been quoted in the literature as a significant contributor for the development of minor complications (17).

The sample size in the present study was not big enough to determine if the possible risk factors were significant or not. However, this does not explain the overall high complication rate observed, implying that there may be other risk factors besides those which were measured in this study, and which may contribute to the development of complications post ileostomy closure. Environmental, genetic and sociocultural health seeking behaviour are possibly some factors which may require further investigation in the future as plausible contributory factors.

Some of the limitations of this study which could be improved upon in the future include a bigger sample population, randomisation of patients to eliminate bias, inclusion of other unmeasured variables in the study design such as patient health seeking behaviour patterns and HIV status of the patient.

This study has several important clinical implications. Patients with renal dysfunction may benefit from early closure of their ilesostomies. In addition to just fast tracking them to surgery, the informed consent process should clearly include a warning about the increased likelihood of development of complications post operatively and a longer hospital stay. These patients are also likely to benefit from being in a high care unit post operatively rather than a general surgical ward.

Although this may have cost implications in an already resource stretched environment, it may in the long term save the money that might be utilised to manage the complications in this group of patients.

In conclusion, the complication rate observed post ileostomy closure in this study was high. The magnitude of these complications are attributable to a multifactorial causality in the South African setting. Renal dysfunction was identified as a statistically significant risk factor for the development of a high complication rate.

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