Dataset Information

Application of the intestine diversion tube with a double-balloon without ileostomy in low rectal cancer.

ABSTRACT:

Background

Ileostomy is often used in low rectal cancer to protect the anastomosis and reduce the incidence of anastomotic leakage. However, the closure of the stoma causes physical and psychological damage to patients. An intestine diversion tube with a double-balloon was designed to remove the need for ileostomy and a secondary surgery, and we sought to verify its effectiveness and safety.

Methods

An intestine diversion tube with a double-balloon was designed, and the experiment was performed in 5 groups of experiment pigs by the same group of physicians. The tube was placed into the ileum through the cecum during surgery. All the animals were anatomized after being anesthetized on the 14th day postoperatively to check the anastomosis and abdominal cavity. The postoperative complications included anastomotic leakage, abdominal or pelvic infection, anastomotic stenosis, postoperative bleeding, intestinal obstruction, reoperation, electrolyte disorder, drainage tube blockage, and drainage tube fall off.

Results

No serious postoperative complications occurred in the 5 animal groups. The average daily drainage tube volume was 188.6 mL, the average drainage tube removal time was 13.4 days, and the average first defecation time was 2.6 days. Postoperative drainage was smooth, and no anastomotic leakage, other complications, or animal deaths occurred.

Conclusions

The use of the intestine diversion tube with a double-balloon was feasible in animal experiments and was safe and effective. The procedure is simple, and suitable for popularization and application in the clinic.

SUBMITTER: Wang H

PROVIDER: S-EPMC10007924 | biostudies-literature | 2023 Feb

REPOSITORIES: biostudies-literature

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Publications

Application of the intestine diversion tube with a double-balloon without ileostomy in low rectal cancer.

Wang Huipeng H Chen Wenjie W Zhou Xiecheng X Ye Tao T Gong Lifeng L Cai Yuankun Y

Journal of gastrointestinal oncology 20230208 1

<h4>Background</h4>Ileostomy is often used in low rectal cancer to protect the anastomosis and reduce the incidence of anastomotic leakage. However, the closure of the stoma causes physical and psychological damage to patients. An intestine diversion tube with a double-balloon was designed to remove the need for ileostomy and a secondary surgery, and we sought to verify its effectiveness and safety.<h4>Methods</h4>An intestine diversion tube with a double-balloon was designed, and the experiment ...[more]

PMID: 36915440

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Project description:IntroductionAnastomotic leakage is the most important complication in colorectal surgery occurring in up to 20% after low anterior rectal resection. Therefore, a diverting ileostomy is usually created during low anterior resection to protect the anastomosis or rather to diminish the consequences in case of anastomotic leakage. The so-called virtual or ghost ileostomy is a pre-stage ostomy that can be easily exteriorised, if anastomotic leakage is suspected, in order to avoid the severe consequences of anastomotic leakage. On the other hand, an actual ileostomy can be avoided in patients, who do not develop anastomotic leakage.Methods and analysisThe GHOST trial is a randomised controlled pilot trial comparing ghost ileostomy with conventional loop ileostomy in patients undergoing low anterior resection with total mesorectal excision for rectal cancer. After screening for eligibility and obtaining informed consent, a total of 60 adult patients are included in the trial. Patients are intraoperatively randomised to the trial groups in a 1:1 ratio after assuring that none of the intraoperative exclusion criteria are present. The main outcome parameter is the comprehensive complication index as a measure of safety. Further outcomes include specific complications, stoma-related complications, complications of ileostomy closure, frequency of transformation of ghost ileostomy into conventional ileostomy, frequency of terminal ostomy creation, proportion of patients with an ostomy at 6 months after index surgery, anorectal function (Wexner score) and quality of life assessed by the European Organisation for Research and Treatment of Cancer (EORTC) QLQ-C30 and CR29 questionnaires. Follow-up for each individual patient will be 6 months.Ethics and disseminationThe GHOST trial has been approved by the Medical Ethics Committee of Heidelberg University (reference number S-694/2017). If the intervention proves to be safe, loop ileostomy could be spared in a large proportion of patients, thus also avoiding stoma-related complications and a second operation (ileostomy closure) with its inherent complications in these patients.Trial registration numberGerman Clinical Trials Registry (DRKS00013997); Universal Trial Number: U1111-1208-9742.

Project description:Background:Diversion colitis (DC) is a non-specific inflammation in the intestinal mucosa with colonic dysfunction after low anterior resection of rectal cancer. It is newly proposed in recent years. With the gradual prolongation time of the ileostomy status, the condition of DC may become increasingly severe. However, the corresponding pathogenesis of DC has not been clarified yet. Methods:Clinical information were collected from patients with low rectal cancer admitted to the Department of Anorectal Surgery, Changzheng Hospital, from April 2017 to April 2019. All patients were underwent laparoscopic low anterior resection combined with terminal ileum enterostomy (dual-chamber). After 3-6 months, selective enterostomy closure surgeries were conducted. Retrospective data were divided into mild and severe groups based on the scores of electronic colonoscopy made during follow-up. We then used chi-square test to comparethe clinical baseline information, clinical symptoms, and endoscopic characteristics between the two groups of patients. The multivariate Cox proportional hazards regression model was applied for estimating the odds ratio (OR) and corresponding 95% confidence interval (CI) to identify potential significant factors affecting severity of DC severity. After that, we recruited 40 patients with low rectal cancer after surgery (enterostomy status) and 40 patients were further classified into mild and severe groups according to the scores of endoscopic examinations. The following indexes were tested in the above two groups patients: calprotectin in intestinal lavage fluid, inflammatory factors in tissue and plasma, and lipopolysaccharide levels in plasma. Moreover, 16s-rDNA sequencing was carried out to analyze the diversity and and differences of microbiome in theintestinal lavage fluid of the two groups. Results:According to the endoscopic scores, there were 52 cases in the mild group and 58 cases in the severe group. We found that the age, BMI, history of diabetes , and the incidence of DC-related clinical symptoms (including abdominal pain, mucus, bloody stool, etc.) were significantly different between the two groups. (P＜0.05). Logistic multi-factor regression analysis results showed that age, BMI, history of diabetes, and symptoms associated with the state of the stoma are the independent risk factors that affect DC severity (P＜0.05). After enterostomy closure surgeries, compared with mild group, patients in the severe group showed much more clinical signs, such as abdominal pain, bloody stools, tenesmus, and anal pain andthe daily number of diarrhea, the time to return to normal stool and the level of CRP in plasma were significantly higher (P＜0.05). Results also showed that age, BMI, history of diabetes, and endoscopic scores were the independent risk factors affecting diarrhea severity after enterostomy closure surgery (P＜0.05). Of the 40 patients with low rectal cancer recruited, 23 were in the mild group and 17 in the severe group.In particular, the levels of calprotectin in the intestinal lavage fluid, TNF-α, IL-1β, IL-6 and IL-17 in mucosal /plasma, and the plasma LPS level of severe group were significantly higher than that of mild group (P＜0.05). . The results of 16s-rDNA sequencing showed that micromicrobiome with high enrichment values primarily consisted of Bifidobacteriales and Prevotella in mild group, whereas that in the severe group consisted of Providencia and Dorea. The functional predictions on such two types of microbiome were mainly focused on lipid synthesis, glycan synthesis, metabolism, and amino acid metabolism pathways.

Project description:BackgroundDiversion colitis (DC) is nonspecific inflammation of the distal intestinal mucosa following disruption of colonic continuity with colonic dysfunction. The colonscopic score is a good tool for differentiating the severity of patients with DC. At present, no studies have analyzed the pathogenesis of DC from the perspective of the diversity and and differences of intestinal flora.MethodsRetrospective study: Clinical information were collected from patients with low rectal cancer admitted to the Department of Anorectal Surgery, Changzheng Hospital, from April 2017 to April 2019. These patients underwent laparoscopic low anterior resection (LAR) combined with terminal ileum enterostomy (dual-chamber). We used chi-square test to comparethe clinical baseline information, clinical symptoms, and colonscopic characteristics between different severity of DC. Propsective oberservational study: We recruited 40 patients with laparoscopic anterior low resection combined with terminal ileum enterostomy and they were further classified into mild group and severe group according to the scores of colonscopic examinations for DC. 16s-rDNA sequencing was carried out to analyze the diversity and and differences of intestinal flora in the intestinal lavage fluid of the two groups.ResultsIn retrospective study, we found that age, BMI, history of diabetes, and symptoms associated with the stoma state were the independent risk factors that affect DC severity (P<0.05). Meanwhile, age, BMI, history of diabetes and colonscopic score were found to be independent risk factors affecting the severity of diarrhea after ileostomy closure surgery(P<0.05), which was consistent with our results of differentiating the severity of DC under endoscopy; In propsective oberservational study, 40 patients with low rectal cancer recruited by sample size calculation, 23 were in the mild group and 17 in the severe group. The results of 16s-rDNA sequencing showed that intestinal flora with high enrichment values primarily consisted of Bifidobacteriales and Prevotella in mild group, whereas that in the severe group consisted of Providencia and Dorea. The functional predictions on such two types of intestinal flora were mainly focused on lipid synthesis, glycan synthesis, metabolism, and amino acid metabolism pathways.ConclusionAfter ileostomy closure surgery, a series of severe clinical symptoms might appear in DC patients. There are significant differences in local and systemic inflammatory responses, composition of intestinal flora between DC patients with different colonscopic scores, which provide a basis for the clinical interventional treatment for DC in patients with permanent stoma.

Dataset Information

Application of the intestine diversion tube with a double-balloon without ileostomy in low rectal cancer.

Background

Methods

Results

Conclusions

Publications

Application of the intestine diversion tube with a double-balloon without ileostomy in low rectal cancer.

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