Completely diverted tube ileostomy versus conventional loop ileostomy

doi:10.21203/rs.3.rs-1658574/v1

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Completely diverted tube ileostomy versus conventional loop ileostomy

https://doi.org/10.21203/rs.3.rs-1658574/v1

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Purpose

Diverting ileostomies are commonly performed to prevent morbidity and mortality caused by colorecta lanastomotic leakage. However, many complications may develop due to loop ileostomy itself and its reversal. In this study, we aimed to compare the outcomes ofcompletely diverted tube ileostomy and conventional loopileostomy.

Methods

The study was designed prospectively, and operations were performed by the same surgeon at a single center. Completely diverted tube ileostomy with the rubber strip was performed in 20 consecutive patients and loop ileostomy was performed in the next 20 consecutive patients who needed diverting stoma. Theprimary outcome of the study is to compare the overall complication rates in both techniques. Length of hospital stay, achieving complete diversion, and length of time with a stoma were evaluated as secondary outcomes.

Results

There were no significant differences in the demographic characteristics between the two groups. Complete diversion was achieved in both groups. The number of patients who developed any kind ofcomplications during the observation period was significantly higher in the loopileostomy group in comparison with tube ileostomy group [13 (65%) vs 3 (15%)respectively, p = 0.002].Median time with stoma was significantly higherin loop ileostomy group compared to tube ileostomy group [270 days (56–443)vs 21 days (14–28) respectively, p < 0.001].

Conclusion

Completely diverted tube ileostomy is superior to loop ileostomy for reasons such as lack of need for reversal surgery and fewer complications.

Tube ileostomy

loop ileostomy

fecal diversion

anastomotic leakage

rectal cancer

The incidence of colorectal anastomotic leakage reported in the literature ranges between 1%-25%[1]. Anastomotic leakage following colorectal anastomosis is associated with serious morbidity and mortality and may result in a permanent stoma[2]. Although loop ileostomy does not prevent a leak, it is a commonly used procedure to prevent serious complications of anastomotic leakages, such as fecal peritonitis and septicemia[3–5]. However, loop ileostomy is associated with many complications such as poor stoma siting, dehydration, electrolyte abnormalities, skin irritation, retraction, ischemia, stoma stenosis, parastomal hernia, prolapse, and psychological detriment[6]. Moreover, there is a need for a second operation to reverse stoma which is associated with significant morbidity and mortality[7, 8]. Alternative techniques for fecal diversion were described toavoid complications associated with a loop ileostomy. One of these alternatives is tube ileostomy. However, many of the described tube ileostomy techniques were not sufficient to provide complete fecal diversion. In a previous study, we have described a new technique of completely diverted tube ileostomy for the protection of colorectal anastomosis[9]. The aim of this study is to compare outcomes of conventional loop ileostomy with recently described completely diverting tube ileostomy.

Study design

This prospective controlled study was conducted in the General Surgery Clinic at Marmara University Education and Research Hospital. Ethics committee approval was obtained from Marmara University Clinical Research Ethics Committee. The study included a total of 40 patients who underwent diversion using either tube ileostomy or loop ileostomy following colorectal resection from July 2018 to July 2020.To prevent selection bias, two groups of consecutive patients were formed. 20 consecutive patients were included in each group of tube and loop ileostomy (Fig. 1).

Tube Ileostomy technique was described and illustrated in detail in the previous study [9] (Fig. 2).Loop Ileostomy was performed by the standard technique commonly used in the practice[10].

Patient evaluation

All patients underwent colorectal resection with a primary anastomosis. Neoadjuvant chemoradiotherapy (CRT), distal rectal tumor, comorbidities, technically insufficient anastomosis, positive air leak test, and very old age were determined as criteria for diversion. Tube ileostomy was performed in 20 consecutive patients, and loop ileostomy was performed in the following 20 consecutive patientswho met these criteria.

Data related to patient age, gender, diagnosis, indication for ileostomy, comorbidity, body mass index (BMI), American Society of Anesthesiologists (ASA) score, tumor location, neoadjuvant CRT, surgical approach (open/laparoscopic), and postoperative ileus were collected prospectively in both groups. Additionally, stoma-related complications (i.e., prolapsus, stricture, retraction, parastomal hernia, mucocutaneous separation, skin maceration), and the timing of stoma closure were assessed in the loop ileostomy group. Stoma closure complications were described as the need for laparotomy during the reversal surgery, surgical site infection, visceral injury during reversal surgery, and postoperative ileus. In the tube ileostomy group, the timing of the rubber strip removal, tube removal, and spontaneous fistula closure was recorded. Stoma-related complications in the tube ileostomy group were determined as skin maceration, peristomal infection,and peritonitis. Complete diversion was defined as no defecation in the presence of diversion.

We compared the severity of complications between the two groups usingthe Clavien-Dindo classification.

To evaluate the psychosocial adjustment of individuals living with a stoma, we used Ostomy Adjustment Inventory-23 (OAI-23) that wasdeveloped by Simmons et al.[11]. This scale is composed of 23 items, with higher scores indicating better adjustment of the patients to the stoma. Because the items of the scale are not suitable for the tube ileostomy patients, we used the scale only in the loop ileostomy group.

Statistical analysis

Data were analyzed using SPSS for Windows, version 23 (SPSS Inc; Chicago, IL, USA). All statistical tests were two-sided, and values of P < 0.05 were considered to be significant. Mann-WhitneyU test or t-test was used for continuous data, and the Fisher exact test or the chi-squared test was used for categorical data.

Outcomes

The primary outcome of this study was to compare the complication rates between tube ileostomy and loop ileostomy. The secondary outcomes were to compare the rate of stoma-free time, duration of hospital stay,and stoma output. The ability to provide complete diversion was evaluated in both groups.

In total, 135 colorectal resections were performed by the same surgeon in Marmara University Education and Research Hospital between July 2018 to July 2020. Among those, a total of 40 patientsneeded protective stoma. Tube ileostomy was performed in 20 consecutive patients, and loop ileostomy was performed in the following 20 consecutive patients. No significant differences were observed between the groups regarding age, gender, BMI, diagnosis, neoadjuvant CRT, and tumor location (Table 1).The vast majority (93%) of the whole cohort was diagnosed with rectal cancer. Complete diversion was achieved in 19 (95%) patients in the loop ileostomy group and20 (100%) patients in the tube ileostomy group, and there was no significant difference.Postoperative ileus developed in two patients in both groups and resolved spontaneously.The median stoma output (which was recorded for 14 days postoperatively) was significantly higher in the loop ileostomy than in tube ileostomy group[775ml/day (450–1500) and 588ml/day (150–1650); p = 0.02, respectively] (Table 2).No significant difference was found between the two groups regarding thetotal length of hospital stay (p = 1.0).

Table 1

Demographic and clinical comparison of the Loop ileostomy and Tube ileostomy patient groups
	Loop Ileostomy N = 20	Tube Ileostomy N = 20	p value
Age (median)	54 (30–72)	58 (36–76)	1
Sex
Male	13 (%65)	14 (%70)	0.7
Female	7 (%35)	6 (%30)	0.7
BMI	27 (22–35)	27 (21–40)	1
ASA score
1	5 (%25)	0 (%0)	0.05
2	15 (%75)	14 (%70)	0.7
3	0 (%0)	6 (%30)	0.02
Median tumor distance from AV (cm)	7 (2–12)	8 (3–40)	1
Diagnosis
Rectal cancer	20 (%100)	17 (%85)	1
Sigmoid cancer	0 (%0)	3 (%15)	1
Preoperative CRT
Yes	11 (%55)	9 (%45)	0.5
No	9 (%45)	11 (%55)	0.5
Type of surgical procedure
Open	19 (%95)	19 (%95)	1
Laparoscopic	1 (%5)	1 (%5)	1
BMI, body mass index; ASA, American Society of Anesthesiologists; AV, anal verge; CRT, chemoradiotherapy

Table 2

Comparison of postoperative outcomes
	Loop Ileostomy N = 20	Tube Ileostomy N = 20	p value
Complete diversion
Yes	19 (%95)	20 (%100)	1
No	1 (%5)	0 (%0)	1
Median daily output (ml)	775 (450–1500)	588 (150–1650)	0.02
Median time spent with a stoma (days)	270 (56–443)	21 (14–28)	< 0.001
Median lenght of hospital stay (days)	12 (5–33)	11 (5–30)	1
Median follow-up period (months)	11 (7–16)	24 (10–28)	< 0.001

Table 3

Comparison of complicatons both groups
	Loop Ileostomy N = 20	Tube Ileostomy N = 20	p value
No. of patients with stoma-related postoperative complications	13 (%65)	2 (%10)	< 0.001
Stoma related complications graded according to the Clavien-Dindo classification
Grade 1	10 (%50)	0 (%0)	< 0.001
Grade 2	1 (%5)	2 (%10)	1
Grade 3a	0 (%0)	0 (%0)	< 0.05
Grade 3b	3 (%15)	0 (%0)
Grade 4a	2 (%10)	0 (%0)
Grade 4b	0 (%0)	0 (%0)
Grade 5	0 (%0)	0 (%0)
Skin maceration	9 (%45)	2 (%10)	0.013
Postoperative ileus	2 (%10)	2 (%10)	1

The median time experienced with thestoma was significantly higher in the loop ileostomy group than in the tube ileostomy group[270 days (56–443) and 21 days (14–28); p < 0.001, respectively].

During a median follow-upof 11 months, the stoma was closed in 8 (40%) patients,while the remaining 11 (55%) patients are still living with a stoma mostly due to ongoing chemotherapy (Fig. 4).

The total number of patients with any complications regarding stoma was significantly higher in the loop ileostomy group compared to the tube ileostomy group [13 (65%) and 2 (10%) respectively, p < 0.001]. According to the Clavien-Dindo classification,10(50%) patients had grade I complications(including skin maceration, dehydration, and prolapse that didn’t require intervention)in the loop ileostomy group, whereas there were none in the tube ileostomy group (p < 0.001).

Among patients with loop ileostomy, stoma prolapse was observed in 2 (10%) patients, skin maceration in 9 (45%), parastomal hernia in 2 (10%), and stoma reversal complications in 3 (15%) patients (Fig. 3). However, only 2 (10%) patients with tube ileostomy had complications after surgery which were a peristomal infection (Clavien-Dindo grade II) that healed with antibiotherapy. Among patients with loop ileostomy, Clavien-Dindo gradeIIIb complications were observed in 3 (15%)patients (prolapse in 1 (5%) patient and incarcerated parastomal hernia in 2 (10%) patients,all required surgical intervention), and grade IVa complications were observed in 2 (10%) patients (organ failure and sepsis following stoma reversal surgeryas a result of anastomotic leakage).Whereas there were none of grade III-IV complications in the tube ileostomy group.

Because skin maceration is a complication that could arise in both groups, it was evaluated between the two groups as a separate entity. Skin maceration was observed in 9 (45%) patients of the loop ileostomy group and in 2 (10%) patients of the tube ileostomy group, which showed a significant difference in favor of the tube ileostomy group (p = 0.013).

The median score of OAI-23 among patients with loop ileostomy was 43 (13–69), and the score was lower than 50 in 84% of the patients. Most of the patients were unable to adjust to the stoma.

The minimal monthly cost of ostomy kit and paste for one patient at the date of the study was about35$.Duringthe follow-up period, the median cost of ostomy kit and paste for the 20 loop ileostomy patients was about 1000$. Furthermore, 11 patients (55%), who still have a stoma, continue to bear this cost. Meanwhile, the median cost of endotracheal tube and nylon bag for tube ileostomy is 10$.

This prospectivestudy compared 2 groups of a total of 40 patients undergoing diversion using either tube or loop ileostomy following colorectal resection. It was concluded that the tube ileostomy is superior to the loop ileostomy in terms of complications related to the stoma.

To the best of our knowledge, this is the first study to compare the loop ileostomy with completely diverting tube ileostomy achieved through temporary occlusion of the distal ileum using a flexible rubber strip.

The prospective design, the use of a control group, and minimizing selection bias by including consecutive patients were also other strengths of this study.

The limitations of this study were the small sample size and short follow-up period. Tube ileostomy was uncommonly reported in the literature and no standardtechnique was described. Using endotracheal tube was previously reported in some studies and it was supposed that the inflated balloon of the tube could occlude the intestinal lumen[12–15]. However, the inflated balloon could not effectively occlude the lumen for a long time, particularlyas the return of motility to the ileum results in the propulsion of its contents past the balloon[16]. Zhou et al.[17] presented a technique to overcome this problem. They used a single line of staples along with tube ileostomy to prevent the early flow of feces to the anastomotic region. They suggested that, after the recovery of intestinal motility, feces will enter the distal limb and will gradually disrupt the staple line; thus, recanalization will occur spontaneously.

Although recanalization of the staple line was observed in all patients, the authors stated that the fate of the staples was unclear. Another weakness of this technique is that the operating surgeon cannot decide the duration of diversion. There is a possibility that recanalization may not occur at all, or it may occur too early, resulting in ineffective diversion. For these reasons, we used an easily removable rubber strip to occlude the ileum, instead of a single row of staples, in the technique that we demonstrated in our previous pilot study, and complete diversion was achieved in all the patients. Rubber band removal time was determined based on the healing of the anastomosis line of each patient. Therefore, effective diversion can be achieved for the desired time.

In previous studies, different materials such as gastrostomy tubes, foley catheters, and endotracheal tubes were used in tube ileostomy. The internal diameters of the tubes range between 18F (6mm) and 28F (9.3mm) [5]. These different tube types could not overcome the problem of kinking and the associated obstruction. Hua et al. [18] discussed that the soft and thin tubes could be easily obstructed and did not provide function. In our study, a reinforced (spiral) endotracheal cuffed tube (Fuzhou Kanglite Surgical Plastic Cement Co. Ltd, Fuzhou, China) with an inner diameter of 7.5 mm was used. Owing to its flexible spiral structure, kinking and obstruction of the tube were prevented. In addition, a spiral tube allows patients to bend the tube and hide it under their clothing, which improves patient comfort.

Previous studies reported that tube ileostomy could not prevent the development of fecal peritonitis caused by anastomotic leakage and, as a result, loop ileostomy has been preferred over tube ileostomy[12–14, 19]. In this study, fecal peritonitis did not occur in any patient.

Although a diverting loop ileostomy is intended to be temporary,large series studies reported that only two-thirds of all temporary stomas were closed, whereas more than 30% of all patients kept their stomas permanently or died before closure[20]. In this study with relatively short follow-up, we observed that more than half of the patients continue to live with loop ileostomy. In 3 (15%) patients, loop ileostomy became permanent due to disease progression, which is consistent with the literature. Whereas no patient in the tube ileostomy group had to live with a stoma. These results suggest that tube ileostomy can reduce the risk of a permanent stoma.

There is plenty of data in the literature on the complications of loop ileostomy [21–23]. In the systemic review by Malik et al. [23], 18 randomized controlled studies were assessed and stoma-related complications by stoma types were presented. Complication rates were reported as follows: peristomal skin complication 14% (5.6–37.8%), high-output stoma 2.4% (0-18.5%), parastomal hernia 2.4% (0-13.3%), stoma retraction 3.1% (0-10.8%) and stoma prolapse 0% (0-5.4%). The study showed that complications have a negative impact on the patient and healthcare professionals and can lead to cost disadvantages.

In a retrospective study by Rondelli et al. [15] comparing loop ileostomy to tube ileostomy using a foley catheter, the two methods were evaluated in terms of complications. When stoma-related complications were evaluated separately, the parastomal hernia was found in 12 (17%), intestinal obstruction in 1 (0.01%), and stoma stenosis in 2 (0.02%) patients of the loop ileostomy group. Although they stated that stoma-related complications such as parastomal hernia were significantly higher in the loop ileostomy group (loop and tube; 12and 0, p < 0.02), their study lacks information on the skin infection or skin maceration. While in our study, stomal prolapse was observed in 2 (10%), parastomal hernia in 2 (10%), and skin maceration in 9 (45%) patients of the loop ileostomy group.

The most likely reason for the higher skin maceration rate in comparison with the literature may be due to the low recognition rate of macerationby health professionals and physicians. In contrast, the incidence of parastomal hernia and prolapse is consistent with the literature. Both tube ileostomy and loop ileostomy have specific complications. For instance, prolapsus is not an expected complication of tube ileostomy. Therefore, it is not reasonable to get significant results by directly comparing these method-specific complications.To overcome this problem, we used the Clavien-Dindo classification to assess the severity of different complications. To the best of our knowledge, this study is the first one to use Clavien-Dindo classification to compare complications that are associated with tube ileostomy and loop ileostomy procedures.

In addition to the complications related to loop ileostomy it also has a negative impact on the quality of life. Studies comparing loop ileostomy to tube ileostomy lack data regarding patients’ adjustment to life with a stoma. We assessed the adjustment of loop ileostomy among the patients, using the OAI-23 questionnaire. Results showed that most of the patients in the loop ileostomy group had problems with adjustment to life with a stoma, encountered restrictions in social activities, and had a constant worry about stoma.

This study showed that there is a 10-fold cost advantage between the two methods in favor of tube ileostomy. It is indisputable that if stoma reversal surgery charges are added to the cost, the difference will be even greater. This apparent cost-advantage shown in this study limited to 20 patients, could be of great value in further studies with a large number of patients.

Although this study showed that tube ileostomy is superior to loop ileostomy in many respects, prospective randomized studies with a larger sample size are needed.

Completely diverting tube ileostomy using a flexible rubber strip was found to be superior to loop ileostomy for reasons such as lack of need for ileostomy reversal surgery, the fact that it results in fewer complications, and provides a significantcostadvantage.Completely diverting tube ileostomy can be easily preferred over loop ileostomy to achieve fecal diversion.

Funding:

This research received no specific grant from any funding agency in the public, commercial, or not-for-profit sectors.

Conflict of interest:

The authors report no conflicts of interest. The authors alone are responsible for the content and writing of the paper.

Ethics approval:

Ethics committee approval was obtained from Marmara University Clinical Research Ethics Committee. The procedures used in this study adhere to the tenets of the Declaration of Helsinki.

Patient consent:

Informed consent was obtained from all individual participants included in the study. Patients’ informed consent was obtained regarding publishing their photographs.

Data availability

The datasets generated during and/oranalysedduringthecurrentstudyareavailablefromthecorrespondingauthor on reasonable request.

Author contributions

All authors contributed to the study conception and design. Material preparation, data collection and analysis were performed byAlisina Bulut and WafiAttaallah. The first draft of the manuscript was written by Alisina Bulut and all authors commented on previous versions of the manuscript. All authors read and approved the final manuscript.

AlisinaBulut: literature search, figures, study design, data collection, data analysis, data interpretation, writing. Wafi Attaallah: literature search, figures, data analysis, data interpretation, writing.

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No competing interests reported.

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Completely diverted tube ileostomy versus conventional loop ileostomy

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Abstract

Purpose

Methods

Results

Conclusion

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Introduction

Material And Methods

Study design

Patient evaluation

Statistical analysis

Outcomes

Results

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Conclusion

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References

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