Ileostomy versus fecal diversion device to protect anastomosis after rectal surgery: a randomized clinical trial

Patients undergoing rectal surgery showed a high incidence (≥ 10%) of anastomotic leakage (AL), which causes fatal abdominopelvic sepsis and leads to severe morbidity and mortality [1, 2]. Although defunctioning ileostomy protects the anastomosis, various complications can arise, including peristomal skin breakdown, stoma necrosis, stoma hernia, stoma retraction, and dehydration [3]. Another study demonstrated that patients with ileostomy immediately felt anxiety and depression [4].

Studies have aimed to reduce stoma-associated complications and rapidly achieve intestinal continuity. Some studies introduced a ghost ileostomy, which allowed for easy ileostomy creation regardless of the primary operation in patients requiring ileostomy [5]. The use of ghost ileostomy was intended to secure the terminal ileum loop to the abdominal wall using a rubber band [5]. The Coloshield, introduced in 1988, is a soft, pliable tube that is secured to the proximal colon to protect the anastomosis as an intracolonic bypass procedure [6, 7].

Here, we tested a device to protect anastomosis and replace ileostomy. Based on previous animal experiments, we developed a fecal diversion device (FDD) with an absorbable mesh band for fixation [8]. Thus, this study aimed to identify the clinical safety and efficacy of the FDD.

This single-center randomized clinical trial of stoma versus FDD was conducted at a tertiary referral hospital in accordance with the declaration of Helsinki and approved by the Institutional Review Board of Yeungnam University Hospital (2015-04-008). When an eligible patient was identified, study inclusion was proposed. After providing informed consent, patients were randomly assigned in a 1:1 ratio to the stoma or FDD group.

FDD and band

The FDD, which consists of a head and tail portion, is a newly designed tube that is inserted into the colon to protect the anastomosis (Fig. 1). The head of the FDD consisted of an inner balloon, two external balloons, and a hole for colon cleansing (Fig. 2). The tail portion of the FDD consisted of a thin silicone tube, catheter complex for the balloons, and wash hole. The thin silicon tube passes through the inside of the anastomosis to prevent feces from coming into contact with the anastomosis.

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We used a band and tension-measuring device to better affix the FDD to the colon. To prevent band erosion, an automatic tension-measuring instrument (ATMI; JSR Medical Inc., Daegu, Korea, Patent pending) was used (Fig. 3a). The ATMI measures the pressure acting on the colon wall and helps ensure that the absorbable poly lactic-co-glycolic acid mesh bands (NEOSORB MESH®^; Samyang Biopham. Co., Daejeon, Korea; Fig. 3b) are of adequate length. The band has a half-life of 6 weeks and helps affix the FDD.

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Surgical procedure

All procedures were performed by experienced colorectal surgeons with an open or laparoscopic technique. Bowel preparation using a polyethylene glycol solution was performed the day before the surgery. After colon mobilization was confirmed, the diseased segment was resected. The colorectal anastomosis was performed using the double stapling technique or handsewn method, followed by a loop ileostomy or FDD procedure.

All stoma group patients underwent ileostomy using standard conventional methods [9]. All patients received enterostomal care education.

The FDD installation process was performed as follows. After the colorectal anastomosis, we marked an installation area in the colon 10–15 cm above the anastomosis site and used the ATMI to determine the appropriate band length. The band was placed through the mesocolon on the outer wall of the colon. The inner balloon of the FDD was inflated and inserted into the colon through the anus. The FDD was inserted where the band was located. The band was placed between the external balloons of the FDD and fixed. The external balloon of the FDD was then expanded and its tail portion was cut outside the body to an appropriate length (Fig. 4).

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All patients were allowed to drink water immediately after the surgery. Once gas was released into the stoma or the anus, a soft diet was started. Patients were discharged if they were able to consume soft diets for 2 consecutive days without problems.

Colonic irrigation through the FDD began the day after the diet was started. Irrigation of the FDD was performed as follows. After the inner FDD balloon was inflated, tepid water (600–1000 mL) was placed through the irrigation catheter into the colon above the FDD. To evacuate the irrigated colonic contents, the patients deflated the inner balloon of the FDD and opened its inner lumen. The evacuation took 15–30 min. Twice-daily irrigation was recommended (Fig. 5).

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All patients routinely underwent abdominopelvic computed tomography (CT) scans at 1 week and a contrast study at 3 weeks postoperative, while an additional contrast study was performed in the stoma group at 10–12 weeks to confirm anastomosis integrity prior to stoma reversal. AL was defined as a defect in the intestinal wall integrity at the anastomosis site regardless of clinical symptoms [10]. The defect was proven by a contrast study or CT scan. Clinical peritonitis without evidence of defects as well as perianastomotic fluid collection with or without gas were considered as AL. The FDD was removed when no evidence of AL was found in the contrast study at 3 weeks postoperative. If AL was found, the FDD was maintained for up to 3 additional weeks and the contrast study was repeated. If the anastomosis was normal on the last contrast study, the FDD was removed. The stoma takedown was performed when no evidence of AL was found in the contrast study at 10–12 weeks; otherwise, it was delayed by 1–2 months. If a persistent sinus was observed, stoma takedown was performed once it had stabilized. The clinical trial was ended after 6 months postoperative.

The overall complication rates were similar between the FDD and stoma groups. The AL rate was also similar in both groups, and FDD did not prevent AL. FDD placement provided rapid intestinal continuity without anesthesia compared to stoma creation. There was no additional cost for maintaining the FDD. However, the FDD did not completely replace the stoma because some patients required a stoma due to AL despite FDD use.

In rectal cancer, a stoma has commonly been used to prevent resultant clinical complications of AL, but the stoma itself can cause many complications [3, 11]. The most common complication of the stoma is skin excoriation [3, 12]. Some patients experienced stomal retraction or obstruction [12]. Rarely, such patients require surgical treatment. In particular, many patients with ileostomy showed dehydration and an electrolyte imbalance such as hypokalemia due to discharge of the contents of the small intestine [3, 12]. Complications related to ileostomy also occurred during ileostomy takedown at a reported 20% incidence [13, 14]. In addition, 25% of patients with rectal cancer did not undergo ileostomy takedown [3]. To reduce those complications, several studies performed early ileostomy takedown [15, 16]. In these studies, there were no significant differences in complications between early and late ileostomy takedown [15, 16]. However, these studies demonstrated that it was possible to reduce ileostomy duration but not reduce the complications caused by the ileostomy itself.

Although the risk of AL is reportedly high in rectal surgery, not all patients who undergo this procedure require an ileostomy. AL was observed in approximately 10–12% of patients who underwent low anterior resection surgery [2, 17, 18]. Several studies demonstrated that ileostomy did not prevent AL [17, 19]. In fact, approximately 90% of patients without AL after rectal surgery did not require an ileostomy. The FDD could protect the anastomosis and provide rapid intestinal continuity in these patients. Thus, the FDD could safely replace the ileostomy in patients without AL.

In this study, the overall leakage rate was 27.8% higher than that reported by other studies [1, 2, 20]. In many studies, AL was defined differently [21]. In some studies, clinical signs of AL were considered important for defining leakage [22, 23]. In this study, all patients underwent abdominopelvic CT at 1 week and contrast enema as a contrast study at 3 weeks regardless of symptom status. If patients showed findings of leakage on the tests at week 1 or 3, whether there were symptoms or not, they were identified as having leakage. In the present study, the contrast enema performed at 3 weeks occasionally showed leakage even if there was no leakage on the CT scan at 1 week. We believe that the leakage rate was high due to our active effort to identify AL.

In this study, colonic erosion was the most common FDD-related complication. We created a band of the same material as Vicryl® (Ethicon) for safety. However, erosion was confirmed in two patients without symptoms of peritonitis. Although few studies have examined colonic erosion, an animal study of FDD had similar results [8]. In the animal study, a non-absorbable band was used. However, there were no serious symptoms requiring reintervention. Thus far, gastric band erosion has been reported [24, 25]. In the gastric band erosion, complete erosion and obstruction were also reported [25]. We believe that the lack of serious complications due to the erosions noted in this study was due to the process occurring very slowly and the fibrosis around the mesh creating a firm seal that prevented local sepsis. We noted this phenomenon in our previous animal experiments [8]. Furthermore, we used an absorbable mesh band instead of the non-absorbable mesh in the animal study. We are currently upgrading the instrument used to measure the pressure applied to the bowel wall to prevent erosion and believe that safer operations will be possible in the next round of trials.

In this study, one patient in the FDD group underwent reoperation due to ischemic necrosis. At the time of surgery, postoperative intestinal adhesion due to previous surgery was severe in the upper abdomen. In the ultra-low anterior resection, we performed high ligation of inferior mesenteric artery and mobilization of spleen flexure for tension-free anastomosis. During the patient’s reoperation, the position of the FDD was found to be satisfactory. The ischemic colitis was located 10 cm above the FDD insertion site. The authors concluded that the cause of ischemic necrosis was caused by an injury to the marginal artery of colon during mobilization of splenic flexure. We reported this situation to the IRB and independent reviewers who were appointed at the time of the study approval. Finally, we concluded that this complication could have occurred during the colon surgery regardless of FDD. We performed end colostomy for the patient’s safety during re-operation.

Furthermore, we recommend using FDD within 6 weeks for safety, because the half-life of the band is 6 weeks. The FDD band is absorbable and weakens over time. If patients use FDD for more than 6 weeks, loose bands can lead to dislocation. Secondly, patients using FDD need irrigation twice a day. Hard stool can block the FDD tube. We conducted irrigation to change the hard stool to a loose stool. Patients are placed in the colon with FDD catheters for 1 l of water for colonic irrigation. Most patients feel bowel movement when they add 1 L of water, and usually one irrigation takes about 30 min.

This study had several limitations. First, it may have been underpowered. No FDD clinical study has been conducted at any other institution. Thus, FDD-related complications were undefined regardless of the preliminary study. The aim of this study was to assess the safety and effectiveness of FDD. However, we used total medical costs to indirectly calculate sample size. It may have been better to calculate the complication rate to evaluate the safety and effectiveness, but since the estimated sample size required too many cases for the study, we used medical expenses as an indirect factor. Higher expenses indicate more complications or lower safety, thus resulting in the sample size of this study. Second, this study was conducted in a single institution. We could not adopt a double-blind technique because of the need for FDD preparation. Finally, the quality of life was not evaluated in this study. However, we identified the possibility of FDD as an alternative technique to conventional stoma procedures.

This study showed the possibility of replacing ileostomy with a new device, FDD. The use of FDD provided faster bowel continuity for patients. This study has several limitations and further research is needed to ensure the safety and efficacy of FDD. However, this study confirms the possible outcomes and complications of FDD use.