|Year : 2021 | Volume
| Issue : 4 | Page : 124-129
The role of mechanical bowel preparation in patients undergoing elective ileostomy closure: A randomized prospective study
Amandeep Singh1, Sarbjeet Singh1, Girish Saini1, Shourabh Sinha1, Haramritpal Kaur2, Sonam Singh1
1 Department of Surgery, GGS Medical College and Hospital, Faridkot, Punjab, India
2 Department of Anaesthesia, GGS Medical College and Hospital, Faridkot, Punjab, India
|Date of Submission||07-Jul-2020|
|Date of Decision||11-Aug-2020|
|Date of Acceptance||18-Mar-2021|
|Date of Web Publication||25-Aug-2021|
Department of Surgery, GGS Medical College and Hospital, Faridkot, Punjab
Source of Support: None, Conflict of Interest: None
Background: Mechanical bowel preparation (MBP) includes cleansing of intestine from its contents by giving oral preparations before surgery to clear fecal material from bowel lumen. It had many proposed advantages that lacked evidence. Recently, due to many notable side effects, the use of MBP had been questioned. This study was performed to compare the surgical outcome with MBP and without MBP in ileostomy closure surgeries.
Materials and Methods: The study was conducted on 80 patients who had ileostomy for more than 3 months. They were randomly divided into two groups of 40, each using computer-generated randomization. Group A patients received MBP on the evening before elective ileostomy closure while Group B patients did not receive any MBP. Postoperatively, patients were kept in the ward and monitored for any complications and total duration of stay in hospital.
Results: The mean postoperative duration of paralytic ileus after ileostomy closure surgery with bowel preparation is 4.1 ± 1.4 days. Without bowel preparation, it is 3.9 ± 1.5 days (P > 0.05). The number of patients with anastomotic leak is 3 (7.5%) in the bowel preparation group and 3 (7.5%) in the group without bowel preparation (P > 0.05). Wound infection is present in 7 (17.5%) patients in the bowel preparation group and 10 (25%) patients in the group without bowel preparation. The number of patients needing surgical intervention in the course of management is 2 (5%) in Group A (with MBP) and 3 (7.5%) in Group B (without MBP). The mean duration of hospital stay with bowel preparation is 10.6 ± 3.6 days and without bowel preparation is 10.8 ± 3.5 days (P > 0.05).
Conclusion: The above study concludes that there is no influence of MBP on surgical anastomosis in ileostomy closure surgeries.
Keywords: Ileostomy closure, mechanical bowel preparation, postoperative complications, total duration of stay in hospital
|How to cite this article:|
Singh A, Singh S, Saini G, Sinha S, Kaur H, Singh S. The role of mechanical bowel preparation in patients undergoing elective ileostomy closure: A randomized prospective study. Formos J Surg 2021;54:124-9
|How to cite this URL:|
Singh A, Singh S, Saini G, Sinha S, Kaur H, Singh S. The role of mechanical bowel preparation in patients undergoing elective ileostomy closure: A randomized prospective study. Formos J Surg [serial online] 2021 [cited 2022 Sep 30];54:124-9. Available from: https://www.e-fjs.org/text.asp?2021/54/4/124/324530
| Introduction|| |
In the developing world, perforation peritonitis is one of the major surgical emergencies. When patients with perforation peritonitis present with sepsis, active tuberculosis, bowel wall edema, or adhesions, exploratory laparotomy with ileostomy formation is a common surgical procedure.
Typhoid is the most common cause of enteric perforations whereas tuberculosis, trauma, and nonspecific enteritis are other common causes., By ileostomy formation, a surgeon tries to give some time to distal bowel healing by means of temporary fecal diversion. Because otherwise, the risk of anastomotic leakage is considered to be very high.
At a later stage when intra-abdominal inflammation subsides, restoration of bowel continuity with anastomosis of the ileum loops is done. Stoma closure surgery functionally behaves like primary anastomosis and is associated with almost similar complications.
Before the discovery of antibiotics and sterilization techniques, fecal matter contamination was considered as a major factor affecting anastomotic outcome. One proposed theory was that in the postoperative period when a patient regains his bowel movement, fecal content in the bowel moves along peristalsis and may be stuck at the anastomotic site. Fecal matter having bacterial contamination impacts these bacteria at the anastomotic site. Another theory proposed was the spillage of intraluminal fecal matter during surgery which may transfer to wound infection and intra-abdominal collection. The theories defining fecal matter as a risk factor for poor surgical outcome evolved into the concept of mechanical bowel preparation (MBP).
MBP includes cleaning of the intestine from its contents by giving oral and rectal preparation before surgery with aim at lowering bacterial load and to reduce the incidence of postoperative anastomotic and infectious complications. It was also hypothesized that it also decreased the intraoperative time and made bowel handling easier.
A variety of methods such as prokinetic drugs, cathartic agents, enema, nasogastric irrigation, oral lavage solution, mannitol, senna, salicylates, sodium phosphate, and distal bowel irrigation are used for MBP. Polyethylene glycol (PEG)-based solutions are commonly used in present-day practice.
However, other thoughts also exist. The use of MBP causes shedding of a superficial layer of bowel epithelium cells which results in interstitial edema in the lamina propria. There is alteration of electrolyte concentration. These changes make intestinal wall more permeable for bacterial translocation and thus result in increased postoperative complications.,
Although most of the studies on bowel preparation were conducted on large intestine surgery, it is observed that bowel preparation is opted as a standard practice in small intestinal surgeries also in India. There is a need for statistical evidence and literature for evaluation of benefits and side effects of MBP practice in small intestinal surgeries also.
This study was performed to compare the surgical outcome with MBP and without MBP and undo some myths about the practice of MBP in ileostomy closure surgeries.
| Materials and Methods|| |
This study was conducted in a prospective randomized control manner in the department of surgery at a tertiary care rural hospital after approval from the institutional ethical committee (IRB: BFUHS/2K18p-TH/1485). Patients who underwent elective ileostomy closure within a duration of November 2017 to March 2019 were included in the study. A total of 80 patients were enrolled and randomly distributed into two groups using computer-generated randomization. According to the computer-generated sequence, patients were either allocated to Group A or Group B. Group A (n = 40) included patients who received MBP on the evening before elective ileostomy closure and Group B (n = 40) included patients who did not receive any MBP before elective ileostomy closure. It was a single-blinded study, and doctors collecting the data regarding the complications were kept blinded about the group allocation till the completion of the study.
Patients with age more than 18 years, having status ileostomy in situ for ≥3 months but <6 months, and planned to undergo ileostomy closure were included in the study after written informed consent.
Patients who had signs and symptoms suggestive of intra-abdominal infection, distal bowel obstruction on loopogram, single loop-out in situ requiring midline opening at the time of surgery, diagnosis of extraintestinal malignancies, diabetes, Crohn's disease, and ulcerative colitis were excluded from the study. Patients with any immunocompromised state or undergoing radiotherapy and chemotherapy, any complicated ileostomy with prolapse or retraction, duration of ileostomy <3 months, history of allergy to bowel preparation ingredients, or those who had a medical condition that would contraindicate bowel preparation, as deemed by the treating physician, such as cardiac, renal, pulmonary, and hepatic insufficiency were also excluded from the study.
Patients underwent a detailed history taking and general physical examination preoperatively. Routine investigations were done along with a loopogram to rule out distal obstruction.
In Group A, the bowel preparation began with a clear liquid diet at noon on the day before surgery. They were put on intravenous fluids at a weight-based maintenance rate. PEG preparation was initiated at 4 pm on the day before surgery at a rate of 25 mL/kg/h (maximum 1 L/h) for 4 h. If the patient was unable to take the preparation orally, a nasogastric tube (NGT) was placed to administer the PEG preparation. Vital parameters such as blood pressure, pulse rate, hydration status, and serum electrolytes both before and after preparation were monitored, and if any deficit was found, it was corrected accordingly. If the ileal effluent contained solid material after 4 h, the preparation was continued.
The distal loop was prepared by normal saline wash until clear fluid came out. Large intestine was prepared by enemas.
In Group B, patients began on a clear liquid diet at noon on the day before surgery. Weight-based maintenance intravenous fluid was started on the day of surgery in the preoperative holding area or in the operating room. They were kept nil by mouth 6 h before surgery according to anesthesia protocol.
In both the groups, preoperative intravenous antibiotics (amoxyclavulanic acid, amikacin, and metronidazole) were administered. Then, the patients underwent elective ileostomy closure. A local elliptical incision was used in all cases. Ileostomy closure was done in two layers with 3-0 silk and 3-0 vicryl. Skin and subcutaneous tissue were closed in a single layer using prolene 1-0. An intra-abdominal drain was placed in each case along with a NGT.
Postoperatively, the patient was kept in ward and was monitored for any complications such as wound infection, intra-abdominal abscess, anastomosis leakage, sepsis formation, or bowel obstruction. Postoperatively, all the patients were kept on the same antibiotics for 3–5 days depending on the condition of patients.
The main outcome was the rate of postoperative surgical site infection and anastomotic failure. Other surgical parameters include intraoperative fecal contamination, operation time, and abdominal or pelvic collection. Time to start oral feeding and duration of hospitalization were also noted. Patients were discharged after suture removal. Patients were followed up to 1 month after discharge to observe for any late complications including late fecal fistula, intestinal obstruction, and abdominal or pelvic abscess.
Postoperative ileus was defined as temporary inhibition of gastrointestinal motility after surgical intervention. It may be due to nonmechanical causes that prevented sufficient oral intake with the presence of clinical signs such as abdominal distention and abdominal tenderness and the absence of normal bowel sounds.
Anastomotic leakage was identified if fecal drainage was evident from abdominal drains or documented by imaging modalities. Abdominal or pelvic abscess was defined as a collection demonstrated by ultrasonography or computed tomography scan in conjunction with elevated temperature or total leukocyte count. All the complications were treated with the help of broad-spectrum antibiotics conservatively or surgically.
Sample size was based on the prevalence rate of acute abdomen in our hospital undergoing exploratory laparotomy (requiring diversion depending on intraoperative findings) which was 5.5% based on previous data. With the assumptions of confidence level of 95% and precision (d) of ± 5% using the formula: N = (Z2α × P × (1 − P))/d2, sample size worked out as 80.
After completion of the study, the results were compiled and statistically analyzed. Data were entered in MS Excel, and analysis was done using SPSS Inc. Released 2007. SPSS for Windows, Version 16.0. Chicago, SPSS Inc. statistical program for Microsoft Windows. Continuous variables were presented as mean and standard deviation (SD) while categorical variables were presented as percentage. The quantitative variables were compared using unpaired Student's test. The qualitative or categorical data were compared using Chi-square test. P < 0.05 was considered statistically significant and <0.001 as highly significant.
| Results|| |
The present study was conducted on 80 adult patients with age >18 years undergoing ileostomy closure. Age characteristics, gender distribution, and indication of ileostomy did not significantly differ between the two groups [Table 1] and [Table 2].
On intraoperative findings, the intraoperative fecal contamination was present in 19 patients out of 40 (47.5%) in the MBP group and 23 patients out of 40 (57.5%) in the NMBP group and was comparable [Table 3]. There was also no significant difference in operative time in the MBP and NMBP groups (116.2 ± 27.4 min versus 128.6 ± 21.4 min, respectively) [Table 3].
On postoperative findings, there was no significant difference in the first bowel movement between Group A and Group B (4.1 ± 1.4 versus 3.9 ± 1.5 days, respectively) [Table 4]. The observed rate of anastomotic leakage was 7.5% (3 patients out of 40) in both of the study groups (P = 1) [Table 4]. The overall wound infection rate in the preparation group was 17.5% (7 patients out of 40) while it was 25% (10 patients out of 40) in the nonpreparation group (P = 0.412) [Table 4]. Other infective complications are also shown in the table but found no significance. There was no significant difference in terms of length of hospital stay in the MBP and NMBP groups (10.6 ± 3.6 days versus 10.8 ± 3.5 days, respectively) [Table 4]. Both the groups were also comparable in terms of blood loss.
There was no mortality within 1 month of follow-up in both the groups; however, 5% (2/40) of patients from the preparation group and 7.5% (3/40) from the nonpreparation group were surgically intervened under anesthesia, and again, ileostomy was done in these cases. In rest of the patients, complications were managed conservatively [Table 4]. Grading of complications according to Clavien–Dindo classification is shown in [Table 5].
|Table 5: Grading of complications according to Clavien-Dindo classification|
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| Discussion|| |
History of gastrointestinal surgery and anastomosis dated back to the era even when surgeons were not aware about the fact that fecal matter is composed of 70% of dead and live bacteria. In the modern world of robotic surgery and minimal access surgery, anastomosis failures were still considered as a major complication and a topic of research.
The constant concern about the high incidence of infectious complications in elective intestinal surgeries had led to the traditional ritual of preoperative MBP. However, most of these theories were based on surgeons' beliefs, experiences, and personal thinking. They lacked analytical studies based on evidence. MBP would please surgeons, who like to operate on clean bowel, but such measures might or might not bring reduced surgical morbidity. Outcome of many emergency intestinal surgeries and results of many independent studies are the reasons to reconsider the effectiveness of MBP.
In fact, the use of MBP might be problematic in patients with impaired renal function, dehydration, hyperkalemia, hyperphosphatemia, congestive heart failure, advanced liver disease, and those taking angiotensin-converting enzyme inhibitors or angiotensin receptor blockers., Fatal fluid and electrolyte shifts might occur during MBP. There was existing evidence that MBP with oral antibiotics reduced the risk of perioperative infections for elective colon surgery. Our randomized prospective study aimed to evaluate MBP utility in elective ileostomy closures.
The present study was conducted on 80 adult patients undergoing elective ileostomy closure. Both the groups were comparable in terms of age, gender distribution, and indication of surgery [Table 1] and [Table 2]. On intraoperative findings, in Group A, 19 (47.5%) patients had intraoperative fecal contamination, while in Group B, 23 (57.5%) patients had intraoperative fecal contamination. Although there was less contamination in Group A (MBP), it was statistically nonsignificant [Table 3]. Bowel preparation might help to decrease the intraluminal fecal matter and decrease operative field contamination. Results by Young et al. concluded that fecal matter contamination decreased with the use of MBP.
Vital parameters such as blood pressure, pulse rate, hydration status, and serum electrolytes were also monitored and found to be comparable between the two groups. This might be due to the fact that we put the patients with MBP on intravenous fluids early as compared to the NMBP group.
As for comparing operative time, in Group A, the mean operative time was 116.3 ± 17.4 min, and in Group B, the mean operative time was 128.6 ± 21.4 min [Table 3]. Again, although duration was less in Group A, it did not reach statistical significance. Chung et al. also considered that bowel preparation improved bowel handling and improved operative duration in surgery.
In the comparison of postoperative paralytic ileus, the mean paralytic ileus observed in bowel preparation Group A was 4.1 ± 1.4 days and 3.9 ± 1.5 days in Group B [Table 3]. It was closely similar to each other, and P value was not statistically significant. This result is similar to Ram et al. in which the time until first bowel movement was comparable between the two groups being 4.3 ± 1.3 days in the nonprepared group and 4.3 ± 1.1 days in the prepared group.
The rate of anastomotic leakage with and without the use of MBP was also found to be comparable [Table 4]. Matthietin et al. conducted a trial on 267 patients. The rate of anastomotic leakage was 3.8% and 2.5% with the use of MBP and without MBP, respectively. Contant et al. found anastomotic leakage in 4.8% of patients in Group A with bowel preparation and 5.4% in Group B without bowel preparation. Penna et al. calculated a rate of anastomotic leakage of 3.8% and 2.5%, respectively, with and without bowel preparation. No statistical significance was noted. Ram et al. also concluded anastomotic leakage of 0.6% in Group MBP and 1.3% in Group NMBP. Hence, there was no benefit in using MBP in view of better anastomosis.
MBP was postulated to cause intraluminal fluid accumulation and decreased the viscosity of luminal content. This improved the transit of the content from the bowel lumen. Therefore, this might result in a decrease in intraluminal bacterial content and spillage occurrence and hence might decrease infectious complications. In the present study comparing infective complications of surgery, in Group A, patients having wound infection, intra-abdominal collections, and deep surgical site infection were 7 (17.5%), 2 (5%), and 3 (8%), respectively [Table 4]. In Group B, incidences of wound infection, intra-abdominal collections, and deep surgical site infection were 10 (25%), 1 (2.5%), and 5 (12.5%), respectively [Table 4]. There was no significant difference in surgical site infection rate in both the groups.
Zmora et al. conducted a study on 329 patients and concluded that the wound infection rate in the MBP group was 6.7% and in the NMBP group was 10.1%. Contant et al. conducted a study on 1354 patients and concluded that the wound infection rate in the MBP group was 13.4%, and in the NMBP group, it was 14%.
In Group A, the mean hospital stay was 10.6 ± 3.6 days, and in Group B, it was 10.8 ± 3.5 days. In both the groups, hospital stay duration was found to be comparable.
Ram et al. recruited 64 patients in a study of 32 patients with and without MBP. The hospitalization period was longer in the bowel prepared group (mean ± SD, 8.2 ± 5.1 days) as compared to the nonprepared group (mean ± SD, 8.0 ± 2.7 days). However, this difference was not statistically significant. Similarly, Bucher et al. observed that the MBP group was associated with longer duration of hospital stay. In the present study, hospital stay with the use of preoperative bowel preparation was found to be equivocal to nonuse of bowel preparation in elective ileostomy closure surgeries.
The present study suggested that there was no difference in primary surgical outcome of patients with classic use of MBP. However, this study had some inherent limitations being with small sample size; it was difficult to arrive at a definitive conclusion. Hence, this study opened the way to large multicentric prospective studies that could be carried out to confirm the results of the present study.
| Conclusion|| |
From the above study, we conclude that MBP has no influence on primary surgical anastomosis in ileostomy closure surgeries. Classical practice of mechanical preparation of bowel is an overrated concept and can be omitted.
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Conflicts of interest
There are no conflicts of interest.
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[Table 1], [Table 2], [Table 3], [Table 4], [Table 5]