Novel Minimally Invasive Surgery Tames Fulminant C. difficile

BOCA RATON, FLA.  – For patients with fulminant Clostridium difficile colitis, minimally invasive temporary loop ileostomy with colonic lavage may offer a novel life- and colon-saving alternative to colectomy.

In a series of 42 consecutive patients with severe complicated C. difficile colitis who underwent the surgery, 30-day mortality was only 19% and 39 patients (93%) preserved their colon, Dr. Brian Zuckerbraun reported at the annual meeting of the American Surgical Association.

This 19% mortality was impressively less than the 50% rate in 42 consecutive historical controls with similar Acute Physiology and Chronic Health Evaluation (APACHE) II scores who underwent subtotal colectomy at the same medical center just prior to introduction of the novel, less invasive operation. And the 50% mortality rate is on the low end of reported series, noted Dr. Zuckerbraun of the University of Pittsburgh.

"This approach may prove to be a better alternative to colectomy, because the colon is usually viable and can recover," he said. "Loop ileostomy and colonic lavage should be considered in all patients with severe complicated C. difficile colitis."

"Also, what we’re finding now because of our outcomes and the smaller insult of this therapy compared to colectomy is that our medical colleagues are willing to consult us earlier in the care of these patients. They’re not just thinking of surgery as a salvage operation when all else has failed," Dr. Zuckerbraun noted.

His presentation drew effusive audience praise.

"Two or three times a year I come across something that causes me to say, ‘I really wish I’d thought of that.’ This is one of those situations. I think this is a wonderful idea," said Dr. Robert G. Sawyer, a discussant.

Dr. Sawyer, professor of surgery and public health sciences and chief of acute care surgery at the University of Virginia, Charlottesville, was particularly impressed that the treatment enabled roughly 90% of patients to save their colon. "I believe this will become the standard technique in the treatment of severe C. difficile colitis in the future," he predicted.

Dr. Merril T. Dayton was equally impressed.

"We may be seeing a bit of history being made here: a new operation. If time bears out your study findings, this is a simpler and effective way to handle these complicated patients," observed Dr. Dayton, professor and chairman of the department of surgery at State University of New York, Buffalo.

Dr. Zuckerbraun explained the rationale for his novel treatment: fulminant C. difficile colitis is a disease of bacterial overgrowth and toxin production in which the colon is usually viable and without necrosis or perforation, meaning that it’s recoverable.

On this basis, he developed a procedure that begins with exploratory laparoscopy or laparotomy. This is followed by creation of a diverting loop ileostomy through which 8 L of propylene glycol electrolyte solution (GoLYTELY) is instilled intraoperatively. Antegrade colonic flushes with 500 mg of vancomycin in 500 mL of diluent are administered every 8 hours for 10 days.

The working hypothesis is that this combination of diversion, propylene glycol lavage, and vancomycin acts in cumulative fashion to reduce C. difficile counts, deprive the pathogen of nutrients, and alter the intraluminal milieu, perhaps changing colonic oxygen tension. Also, there is preliminary evidence to suggest propylene glycol may exert a pharmacologic effect involving protection of the colonic epithelium.

The 42 patients in his series were quite sick, with a mean APACHE II score of 29.7. Many were immunosuppressed. Preoperatively, 90% were in the intensive care unit, where most were intubated and/or on vasopressors.

Loop ileostomy and colonic lavage were accomplished laparoscopically in 35 of 42 patients. With increased experience, Dr. Zuckerbraun and his colleagues have decided that the only indication for open loop ileostomy via laparotomy is abdominal compartment syndrome.

One patient with abdominal compartment syndrome underwent colectomy immediately after loop ileostomy. Two more patients had colectomies during the postoperative period based upon clinical symptoms.

Eight patients died a mean of 13 days after surgery. Of the 34 who survived the 30-day postoperative period, 6 have subsequently died because of comorbid disease – none of these deaths was related to C. difficile.

Twenty-eight patients remain alive at a mean follow-up of 11.4 months. Of the 19 who have been followed for at least 6 months, 15 (79%) have had their ileostomies reversed. Surgeons initially considered performing the reversal during the same hospital stay, but they decided patients with fulminant C. difficile colitis have too many serious comorbidities to be able to handle a second operation early on.

"Most have required months to recover from the illness that brought them into the hospital in the first place, which often wasn’t C. difficile. We wait until they’re back on their feet again," Dr. Zuckerbraun explained.

The indications for temporary loop ileostomy and colonic lavage are, first, diagnosis of C. difficile colitis by toxin assay, a compatible CT scan, or endoscopic findings, along with any one of the following criteria: sepsis, peritonitis, change in mental status, ventilatory failure, vasopressor requirement, worsening abdominal pain or distention, or unexplained clinical deterioration, he said.

At the urging of medical intensivists and transplant physicians, the investigators have also performed this operation in two patients with multiple recurrent episodes of C. difficile colitis who were not critically ill. One patient had 19 prior episodes. The C. difficile was successfully eradicated in both cases. The new procedure, however, was undertaken only after the patients failed a trial of high-volume propylene glycol lavage by nasogastric tube, which the investigators have previously employed successfully to eradicate C. difficile infections in several other patients with multiply recurrent nonfulminant colitis.

Severe, complicated C. difficile colitis occurs in 4%-10% of C. difficile-associated disease, which is now the most common nosocomial infection.

Dr. Zuckerbraun reported no conflicts of interest.

BOCA RATON, FLA.  – For patients with fulminant Clostridium difficile colitis, minimally invasive temporary loop ileostomy with colonic lavage may offer a novel life- and colon-saving alternative to colectomy.

In a series of 42 consecutive patients with severe complicated C. difficile colitis who underwent the surgery, 30-day mortality was only 19% and 39 patients (93%) preserved their colon, Dr. Brian Zuckerbraun reported at the annual meeting of the American Surgical Association.

This 19% mortality was impressively less than the 50% rate in 42 consecutive historical controls with similar Acute Physiology and Chronic Health Evaluation (APACHE) II scores who underwent subtotal colectomy at the same medical center just prior to introduction of the novel, less invasive operation. And the 50% mortality rate is on the low end of reported series, noted Dr. Zuckerbraun of the University of Pittsburgh.

"This approach may prove to be a better alternative to colectomy, because the colon is usually viable and can recover," he said. "Loop ileostomy and colonic lavage should be considered in all patients with severe complicated C. difficile colitis."

"Also, what we’re finding now because of our outcomes and the smaller insult of this therapy compared to colectomy is that our medical colleagues are willing to consult us earlier in the care of these patients. They’re not just thinking of surgery as a salvage operation when all else has failed," Dr. Zuckerbraun noted.

His presentation drew effusive audience praise.

"Two or three times a year I come across something that causes me to say, ‘I really wish I’d thought of that.’ This is one of those situations. I think this is a wonderful idea," said Dr. Robert G. Sawyer, a discussant.

Dr. Sawyer, professor of surgery and public health sciences and chief of acute care surgery at the University of Virginia, Charlottesville, was particularly impressed that the treatment enabled roughly 90% of patients to save their colon. "I believe this will become the standard technique in the treatment of severe C. difficile colitis in the future," he predicted.

Dr. Merril T. Dayton was equally impressed.

"We may be seeing a bit of history being made here: a new operation. If time bears out your study findings, this is a simpler and effective way to handle these complicated patients," observed Dr. Dayton, professor and chairman of the department of surgery at State University of New York, Buffalo.

Dr. Zuckerbraun explained the rationale for his novel treatment: fulminant C. difficile colitis is a disease of bacterial overgrowth and toxin production in which the colon is usually viable and without necrosis or perforation, meaning that it’s recoverable.

On this basis, he developed a procedure that begins with exploratory laparoscopy or laparotomy. This is followed by creation of a diverting loop ileostomy through which 8 L of propylene glycol electrolyte solution (GoLYTELY) is instilled intraoperatively. Antegrade colonic flushes with 500 mg of vancomycin in 500 mL of diluent are administered every 8 hours for 10 days.

The working hypothesis is that this combination of diversion, propylene glycol lavage, and vancomycin acts in cumulative fashion to reduce C. difficile counts, deprive the pathogen of nutrients, and alter the intraluminal milieu, perhaps changing colonic oxygen tension. Also, there is preliminary evidence to suggest propylene glycol may exert a pharmacologic effect involving protection of the colonic epithelium.

The 42 patients in his series were quite sick, with a mean APACHE II score of 29.7. Many were immunosuppressed. Preoperatively, 90% were in the intensive care unit, where most were intubated and/or on vasopressors.

Loop ileostomy and colonic lavage were accomplished laparoscopically in 35 of 42 patients. With increased experience, Dr. Zuckerbraun and his colleagues have decided that the only indication for open loop ileostomy via laparotomy is abdominal compartment syndrome.

One patient with abdominal compartment syndrome underwent colectomy immediately after loop ileostomy. Two more patients had colectomies during the postoperative period based upon clinical symptoms.

Eight patients died a mean of 13 days after surgery. Of the 34 who survived the 30-day postoperative period, 6 have subsequently died because of comorbid disease – none of these deaths was related to C. difficile.

Twenty-eight patients remain alive at a mean follow-up of 11.4 months. Of the 19 who have been followed for at least 6 months, 15 (79%) have had their ileostomies reversed. Surgeons initially considered performing the reversal during the same hospital stay, but they decided patients with fulminant C. difficile colitis have too many serious comorbidities to be able to handle a second operation early on.

"Most have required months to recover from the illness that brought them into the hospital in the first place, which often wasn’t C. difficile. We wait until they’re back on their feet again," Dr. Zuckerbraun explained.

The indications for temporary loop ileostomy and colonic lavage are, first, diagnosis of C. difficile colitis by toxin assay, a compatible CT scan, or endoscopic findings, along with any one of the following criteria: sepsis, peritonitis, change in mental status, ventilatory failure, vasopressor requirement, worsening abdominal pain or distention, or unexplained clinical deterioration, he said.

At the urging of medical intensivists and transplant physicians, the investigators have also performed this operation in two patients with multiple recurrent episodes of C. difficile colitis who were not critically ill. One patient had 19 prior episodes. The C. difficile was successfully eradicated in both cases. The new procedure, however, was undertaken only after the patients failed a trial of high-volume propylene glycol lavage by nasogastric tube, which the investigators have previously employed successfully to eradicate C. difficile infections in several other patients with multiply recurrent nonfulminant colitis.

Severe, complicated C. difficile colitis occurs in 4%-10% of C. difficile-associated disease, which is now the most common nosocomial infection.

Dr. Zuckerbraun reported no conflicts of interest.

BOCA RATON, FLA.  – For patients with fulminant Clostridium difficile colitis, minimally invasive temporary loop ileostomy with colonic lavage may offer a novel life- and colon-saving alternative to colectomy.

In a series of 42 consecutive patients with severe complicated C. difficile colitis who underwent the surgery, 30-day mortality was only 19% and 39 patients (93%) preserved their colon, Dr. Brian Zuckerbraun reported at the annual meeting of the American Surgical Association.

This 19% mortality was impressively less than the 50% rate in 42 consecutive historical controls with similar Acute Physiology and Chronic Health Evaluation (APACHE) II scores who underwent subtotal colectomy at the same medical center just prior to introduction of the novel, less invasive operation. And the 50% mortality rate is on the low end of reported series, noted Dr. Zuckerbraun of the University of Pittsburgh.

"This approach may prove to be a better alternative to colectomy, because the colon is usually viable and can recover," he said. "Loop ileostomy and colonic lavage should be considered in all patients with severe complicated C. difficile colitis."

"Also, what we’re finding now because of our outcomes and the smaller insult of this therapy compared to colectomy is that our medical colleagues are willing to consult us earlier in the care of these patients. They’re not just thinking of surgery as a salvage operation when all else has failed," Dr. Zuckerbraun noted.

His presentation drew effusive audience praise.

"Two or three times a year I come across something that causes me to say, ‘I really wish I’d thought of that.’ This is one of those situations. I think this is a wonderful idea," said Dr. Robert G. Sawyer, a discussant.

Dr. Sawyer, professor of surgery and public health sciences and chief of acute care surgery at the University of Virginia, Charlottesville, was particularly impressed that the treatment enabled roughly 90% of patients to save their colon. "I believe this will become the standard technique in the treatment of severe C. difficile colitis in the future," he predicted.

Dr. Merril T. Dayton was equally impressed.

"We may be seeing a bit of history being made here: a new operation. If time bears out your study findings, this is a simpler and effective way to handle these complicated patients," observed Dr. Dayton, professor and chairman of the department of surgery at State University of New York, Buffalo.

Dr. Zuckerbraun explained the rationale for his novel treatment: fulminant C. difficile colitis is a disease of bacterial overgrowth and toxin production in which the colon is usually viable and without necrosis or perforation, meaning that it’s recoverable.

On this basis, he developed a procedure that begins with exploratory laparoscopy or laparotomy. This is followed by creation of a diverting loop ileostomy through which 8 L of propylene glycol electrolyte solution (GoLYTELY) is instilled intraoperatively. Antegrade colonic flushes with 500 mg of vancomycin in 500 mL of diluent are administered every 8 hours for 10 days.

The working hypothesis is that this combination of diversion, propylene glycol lavage, and vancomycin acts in cumulative fashion to reduce C. difficile counts, deprive the pathogen of nutrients, and alter the intraluminal milieu, perhaps changing colonic oxygen tension. Also, there is preliminary evidence to suggest propylene glycol may exert a pharmacologic effect involving protection of the colonic epithelium.

The 42 patients in his series were quite sick, with a mean APACHE II score of 29.7. Many were immunosuppressed. Preoperatively, 90% were in the intensive care unit, where most were intubated and/or on vasopressors.

Loop ileostomy and colonic lavage were accomplished laparoscopically in 35 of 42 patients. With increased experience, Dr. Zuckerbraun and his colleagues have decided that the only indication for open loop ileostomy via laparotomy is abdominal compartment syndrome.

One patient with abdominal compartment syndrome underwent colectomy immediately after loop ileostomy. Two more patients had colectomies during the postoperative period based upon clinical symptoms.

Eight patients died a mean of 13 days after surgery. Of the 34 who survived the 30-day postoperative period, 6 have subsequently died because of comorbid disease – none of these deaths was related to C. difficile.

Twenty-eight patients remain alive at a mean follow-up of 11.4 months. Of the 19 who have been followed for at least 6 months, 15 (79%) have had their ileostomies reversed. Surgeons initially considered performing the reversal during the same hospital stay, but they decided patients with fulminant C. difficile colitis have too many serious comorbidities to be able to handle a second operation early on.

"Most have required months to recover from the illness that brought them into the hospital in the first place, which often wasn’t C. difficile. We wait until they’re back on their feet again," Dr. Zuckerbraun explained.

The indications for temporary loop ileostomy and colonic lavage are, first, diagnosis of C. difficile colitis by toxin assay, a compatible CT scan, or endoscopic findings, along with any one of the following criteria: sepsis, peritonitis, change in mental status, ventilatory failure, vasopressor requirement, worsening abdominal pain or distention, or unexplained clinical deterioration, he said.

At the urging of medical intensivists and transplant physicians, the investigators have also performed this operation in two patients with multiple recurrent episodes of C. difficile colitis who were not critically ill. One patient had 19 prior episodes. The C. difficile was successfully eradicated in both cases. The new procedure, however, was undertaken only after the patients failed a trial of high-volume propylene glycol lavage by nasogastric tube, which the investigators have previously employed successfully to eradicate C. difficile infections in several other patients with multiply recurrent nonfulminant colitis.

Severe, complicated C. difficile colitis occurs in 4%-10% of C. difficile-associated disease, which is now the most common nosocomial infection.

Dr. Zuckerbraun reported no conflicts of interest.