Short summary

In patients with colitis ulcerosa undergoing proctocolectomy with ileal pouch-anal anastomosis, it is common practice to place a temporary ileostomy to minimize the risk of servere complications like anastomotic leakage. Contrary it is not without risks and complications placing an ileostomy. Therefore, we have decided to investigate the rate of complications when placing and reversing the ileostomy and the rate of complications regarding the ileal pouch-anal anastomisis with or without a meanwhile temporary ileostomy.

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Rationale

Inflammatory bowel disease like colitis ulcerosa (CU) do in case of resistance to medical treatment need removal of the large intestine. Most patients prefer a small intestine reservoir (J-pouch) to maintaine intestinal continuity instead of a permanent ileostomy. The most feared complication with an ileal pouch-anal anastomosis is anastomotic leakage. This complication happens in 10-15% of the cases and can lead to infection, abscess and pelvic sepsis. The consequences of pelvic sepsis can be deficient working pouch, which in the short and long term can lead to a permanent stomy.

To minimize the risk of these server complications, it is common practice to make a temporary loop-ileostomy when doing the pouch surgery. Thus, the feaces can be led round the pouch the first months after surgery. The loop-ileostomy is normally reversed after three months, which can be done as a small surgical procedure through the opening in the abdominal wall made for the ileostomy. In some cases, a temporary ileostomy must be refrained from because of anatomical reasons or patient whishes. To justify the making of a temporary ileostomy its protective effect must be held up against the risks related to its placing, function of the stomy and complications related to the reversal of it.

In relation to the placing of a loop-ileostomy, complications like bleeding, infections and ischemia can happen, which often will lead to re-surgery and a new stomy; most likely and end-stomy. It will cause a larger surgical procedure reversing this compared to a loop-ileostomy. The time while patiens have the loop-ileostomy can be affected by lacking function of the stomy as a result of stenosis, which can lead to several endoscopic treatments or re-surgery. Another issue is dehydration and displacement of electrolytes because of large stomy output, which again can lead to several rehospitalizations for treatments with intravenous fluids. In relation to reversing the stomy leakage from the anastomosis is a feared complication, since it can be life threatening and lead to re-surgery with re-placing the stomy.

The existing litterature on mobidity in relation to loop-ileostomy and its protective effect for an ileo pouch-anal anastomosis is controversial, and still discussed. The evidens is primarily based on retrospective studies and a single randomized study. Therefore, as a register study, we have decided to investigate the rate of complications when placing and reversing the ileostomy and the rate of complications regarding the ileal pouch-anal anastomosis with or without a sametime temporary ileostomy.

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Description of the cohort

Patients having an ileal pouch-anal anastomosis are identified in F-pas and C-pas at Odense University Hospital, Vejle Hospital, Esbjerg Hospital, Sønderborg Hospital and Aabenraa Hospital in the period 1983-2015 by using the diagnostic codes mentioned here:

• KJFH30 Colectomy and mucosal rectotomy with ileoanal anastomosis without ileostomy
• KJFH31 Laparoscopic colectomy and mucosal rectotomy with ileoanal anastomosis without ileostomy
• KJFH33 Colectomy and mucosal rectotomy with ileoanal anastomosis with ileostomy
• KJGB50 Mucosal proctectomy and ileoanal anastomosis
• KJGB60 Excision of rectum and ileoanal anastomosis after previos colectomy
• KJGB61 Laparoscopic excision of rectum and ileoanal anastomosis after previos colectomy

Data and biological material

Informations are collected by running through patient journals manually. There will not be any directly contact with the patients. Following data are registered:

1. Age, sex and weight on day of pouch-surgery
2. One-, two- or three step surgery
3. Descriptions of the pouch-surgery and whether there has been made a temporary ileostomi or not and background for NOT making one if that is the case
4. Method of pouch-surgery; open or laparoscopic.
5. CT-scan descriptions the first 30 postoperative days after pouch-surgery, concerning anastomotic leakage or pelvic sepsis
6. Date of ileostomy reversal surgery
7. Descriptions of pouch-related surgeries
8. Data from infusions of blood and fluids
9.  Use of antibiotics and number of days more than then sceduled 3 or 5 postoperative days
10. Date and cause of re-hospitalization within the 30 first postoperative days after pouch-surgery and ileostomy reversal surgery
11. Use of immunosuppressiv, immunomodulating and biological medicine prior pouch-surgey (for steroids and immunological medicine: max dose 4 weeks prior and dose just prior surgery, and dose just prior surgery for biological medicine)
12. Date of and descriptions from pouch-removal surgery in cases where that happened
13. Date of last contact or death

Collaborating researchers and departments

Department of Surgery, Odense University Hospital

• Professor Niels Qvist
• Specialist registrar Joan Anwar Reza
• Specialist registrar Mark Bremholm Ellebæk
• Senior resident Mie Dilling Kjær
• Resident Karen Strebel