Japanese Practice Guidelines for Fecal Incontinence Part 3 -Surgical Treatment for Fecal Incontinence, Fecal Incontinence in a Special Conditions- English Version.

In Japan, the surgical treatment for fecal incontinence (FI) can be performed using minimally invasive surgery, such as anal sphincteroplasty and sacral neuromodulation (SNM), as well as antegrade continence enema (ACE), graciloplasty, and stoma construction. In addition, currently, several other procedures, including biomaterial injection therapy, artificial bowel sphincter (ABS), and magnetic anal sphincter (MAS), are unavailable in Japan but are performed in Western countries. The evidence level of surgical treatment for FI is generally low, except for novel procedures, such as SNM, which was covered by health insurance in Japan since 2014. Although the surgical treatment algorithm for FI has been chronologically modified, it should be sequentially selected, starting from the most minimally invasive procedure, as FI is a benign condition. Injuries to the neural system or spinal cord often cause disorders of the sensory and motor nerves that innervate the anus, rectum, and pelvic floor, leading to the difficulty in controlling bowel movement or FI and/or constipation. FI and constipation are closely associated; when one improves, the other tends to deteriorate. Patients with severe cognitive impairment may present with active soiling, referred to as "incontinence" episodes that occur as a consequence of abnormal behavior, and may also experience passive soiling.

The Japanese Extracted Herbal Medicine Daikenchuto Increases the Contractile Activity of the Internal Anal Sphincter Muscle in Conscious Dogs.

OBJECTIVES: This study aimed to elucidate the effect of the extract of daikenchuto (DKT), a Japanese Kampo medicine, on the contractile activity of the internal anal sphincter in conscious dogs. METHODS: Force transducers were attached to the serosal surface of the rectum and the internal anal sphincter of male beagle dogs. In addition, the contractile activity of the rectum and the internal anal sphincter was continuously measured until 6 h after DKT administration via telemetry in the conscious state. The DKT dose was 1.5 g/body, and the administration route was intrarectal in the expectation of a direct effect on the rectoanal region. DKT was re-administered to the same animal after drug withdrawal, and the plasma concentrations of hydroxy-α-sanshool (HAS) and hydroxy-ß-sanshool (HBS) before and after administration were measured. RESULTS: After DKT administration, the contractile activity of the internal anal sphincter immediately increased, peaked at 10 min, continued for ≥1 h, and had almost disappeared after 4 h. Rectal contraction differed from that of the internal anal sphincter, with no significant contraction observed. HAS and HBS were found in the plasma of animals administered with DKT and persisted up to 2 h after the administration. CONCLUSIONS: This is the first report on in vivo telemetry demonstrating that DKT exhibited contractile effects on the dog's internal anal sphincter. The increased anal pressure and improvement of fecal incontinence symptoms observed in previous clinical studies may have been based on this sphincter contraction.

Daikenchuto accelerates the recovery from prolonged postoperative ileus after open abdominal surgery: a subgroup analysis of three randomized controlled trials.

PURPOSE: Prolonged postoperative ileus (POI) is a common complication after open abdominal surgery (OAS). Daikenchuto (DKT), a traditional Japanese medicine that peripherally stimulates the neurogenic pathway, is used to treat prolonged POI in Japan. To analyze whether DKT accelerates the recovery from prolonged POI after OAS, we conducted a secondary analysis of three multicenter randomized controlled trials (RCTs). METHODS: A secondary analysis of the three RCTs supported by the Japanese Foundation for Multidisciplinary Treatment of Cancer (project numbers 39-0902, 40-1001, 42-1002) assessing the effect of DKT on prolonged POI in patients who had undergone OAS for colon, liver, or gastric cancer was performed. The subgroup included 410 patients with no bowel movement (BM) before the first diet, a DKT group (n = 214), and a placebo group (n = 196). Patients received either 5 g DKT or a placebo orally, three times a day. The primary endpoint was defined as the time from the end of surgery to the first bowel movement (FBM). A sensitivity analysis was also performed on the age, body mass index and dosage as subgroup analyses. RESULTS: The primary endpoint was significantly accelerated in the DKT group compared with the placebo group (p = 0.004; hazard ratio 1.337). The median time to the FBM was 113.8 h in the placebo group and 99.1 h in the DKT treatment group. CONCLUSIONS: The subgroup analysis showed that DKT significantly accelerated the recovery from prolonged POI following OAS. TRIAL REGISTRATION NUMBER: UMIN000026292.

Successful repair of a rectovaginal fistula caused by a tension-free vaginal mesh (TVM): a case report.

Rectovaginal fistula caused by a tension-free vaginal mesh (TVM) is a rare condition. Moreover, a rectovaginal fistula is a challenging issue to address for surgeons regardless of causes. Due to a low rate of occurrence, treatment modality for a rectovaginal fistula caused by a TVM has previously received little attention. A successful surgery using several key techniques to address a rectovaginal fistula caused by a TVM is herein reported. A 78-year-old woman who underwent a TVM for a rectocele three months ago was referred to our hospital with a two-month history of anal bleeding. Mesh protruding into both the vagina and the rectum was confirmed. The patient was operated on under diagnosis of a rectovaginal fistula caused by TVM. TVM was removed by transvaginal dissection of the rectovaginal septum with division of both anterior and posterior arms of the TVM. Layer-to-layer sutures of rectal and vaginal walls were crossly performed with a drain placed in the rectovaginal septum after saline irrigation followed by a covering sigmoid colostomy. The wound healed without infection after surgery, and a water-soluble contrast enema demonstrated the healing of the rectovaginal fistula two months after surgery. No recurrent fistula was confirmed 15 months after stoma closure.

Clinical pharmacology of daikenchuto assessed by transit analysis using radiopaque markers in patients with colon cancer undergoing open surgery: a multicenter double-blind randomized placebo-controlled study (JFMC39-0902 additional study).

BACKGROUND: This exploratory trial was conducted to investigate whether daikenchuto accelerates the recovery of gastrointestinal function in patients undergoing open surgery for sigmoid or rectosigmoid cancer. METHODS: Eighty-eight patients who underwent colectomy at one of the 11 clinical trial sites in Japan from January 2009 to June 2011 were registered in the study. Patients received either placebo or daikenchuto (15.0 g/day, 5 g three times a day) from postoperative day 2 to postoperative day 8. The study end points included the gastrointestinal tract transit time evaluated with radiopaque markers and the time to first flatus. The safety profile of daikenchuto was also evaluated until postoperative day 8. RESULTS: Seventy-one patients (daikenchuto, n = 38; placebo, n = 33) were statistically analyzed. Although the number of radiopaque markers in the anal side of the small intestine at 6 h was significantly greater in the daikenchuto group than in the placebo group (15.19 vs 10.06, p = 0.008), the total transit analysis results and the mean time to first flatus did not differ significantly between the two groups. CONCLUSIONS: Daikenchuto has a positive effect on the resolution of delayed gastric emptying, but has a limited effect on the resolution of postoperative paralytic ileus after open surgery in patients with sigmoid or rectosigmoid cancer. Daikenchuto may contribute to early oral intake in the postoperative course.

Clinical efficacy of Daikenchuto for gastrointestinal dysfunction following colon surgery: a randomized, double-blind, multicenter, placebo-controlled study (JFMC39-0902).

OBJECTIVE: This exploratory trial was performed to determine whether Daikenchuto accelerates recovery of gastrointestinal function in patients undergoing open colectomy for colon cancer. METHODS: A total of 386 patients undergoing colectomy at 1 of the 51 clinical trial sites in Japan from January 2009 to June 2011 were registered for the study (JFMC39-0902). Patients received either placebo or Daikenchuto (15.0 g/day, t.i.d) between post-operative day 2 and post-operative day 8. Primary end-points included time to first bowel movement, frequency of bowel movement and stool form. The incidence of intestinal obstruction was evaluated post-operatively. The safety profile of Daikenchuto until post-operative day 8 was also evaluated. RESULTS: The results for 336 patients (Daikenchuto, n = 174; placebo, n = 162) were available for statistical analysis. The time to first bowel movement did not differ significantly between the two groups. All patients reported having diarrhea or soft stools immediately after surgery, and the time until stool normalization (50th percentile) in the Daikenchuto and placebo groups was 6 days and 7 days, respectively. The placebo group had a significantly greater number of hard stools at post-operative day 8 (P = 0.016), and bowel movement frequency continued to increase until post-operative day 8 as well. In contrast, bowel movement frequency in the Daikenchuto group increased until post-operative day 6, however decreased from post-operative day 7 and was significantly lower at post-operative day 8 compared with the placebo group (P = 0.024). CONCLUSION: The moderate effects of Daikenchuto were observed ∼1 week after the operation. Although Daikenchuto had an effect on gastrointestinal function after open surgery in patients with colon cancer, this study did not show its clinical benefits adequately.

When is local excision appropriate for "early" rectal cancer?

Local excision is increasingly performed for "early stage" rectal cancer in the US; however, local recurrence after local excision has become a controversial issue in Western countries. Local recurrence is considered to originate based on the type of tumor and procedure performed, and in surgical margin-positive cases. This review focuses on the inclusion criteria of "early" rectal cancers for local excision from the Western and Japanese points of view. "Early" rectal cancer is defined as T1 cancer in the rectum. Only the tumor grade and depth of invasion are the "high risk" factors which can be evaluated before treatment. T1 cancers with sm1 or submucosal invasion <1,000 µm are considered to be "low risk" tumors with less than 3.2 % nodal involvement, and are considered to be candidates for local excision as the sole curative surgery. Tumors with a poor tumor grade should be excluded from local excision. Digital examination, endoscopy or proctoscopy with biopsy, a barium enema study and endorectal ultrasonography are useful for identifying "low risk" or excluding "high risk" factors preoperatively for a comprehensive diagnosis. The selection of an initial local treatment modality is also considered to be important according to the analysis of the nodal involvement rate after initial local treatment and after radical surgery.

[Effectiveness and motion mechanism of Taikencyuto in the perioperative period].

Taikencyuto (TJ-100) is a Japanese herbal (Kampo) medicine that contains Zanthouxylum and piperitum, Zingiber officinale, Panax ginseng, and Saccharum granorum. TJ-100 enhances intestinal motility, is thought to promote acetylcholine and motilin release, and is a vanilloid receptor. Furthermore, TJ-100 increases intestinal blood flow and works as an antiinflammatory and anticytokine agent by producing calcitonin gene-related peptide and adrenomedullin. TJ-100 is considered to be useful for promoting intestinal motility and preventing ileus during the perioperative period. Further studies must be performed to confirm its usefulness in perioperative care.