| Objective: |
In the process of colon resection with critical anastomoses, a so-called protective loop-ileostomy is often formed. In this case, the following intestinal segments are excluded from the passage of food/stool and any anastomotic insufficiencies that may occur can then heal under the "protection" of the ileostomy with conservative or interventional therapy, such as drainage or endoscopic treatment (e.g. Endoscopic-V.A.C.-therapy). Without a stoma the risk of fecal peritonitis with abdominal septic findings requiring revision is higher. In most cases with anastomotic leckage without a loop-ileostomy and fecal peritonitis the anastomosis then needs to be removed and a discontinuity situation has to be created (so-called Hartmann operation) - with serious adverse consequences for the patient. In the case of sigmoid resection, reconnection can be done technically, but the rate of reconstructive surgery in the case of colonic discontinuity is significantly lower than in the case of protective loop-ileostomy. In the case of low rectal resections, very rarely continuity reconstruction is technically possible with a short rectal stump, so that these patients require a terminal colostomy. Therefore, the creation of a protective loop ileostomy has become established in emergency operations for sigmoid diverticulitis or in elective rectal resection for rectal cancer with total mesorectal excision (TME) and deep anastomosis [1, 2, 3]. Following ileostomy reversal can be performed via a limited access by excision of both stoma loops from the cutis/subcutis, fascia and limited abdominal adhesiolysis. After elevation of both stoma loops above skin level, a sparing small bowel segment resection of both stoma loops with end-to-end ileo-ileostomy can be performed. Even though this operation is technically not very complex and demanding, relevant morbidity rates of up to 29-57%, re-operation rates of 2-7% and mortality rates of up to 1% are reported in literature.
The most frequent postoperative complications are postoperative ileus/postoperative intestinal paralysis in 13-38%. In addition, anastomotic leckage rates are significantly more frequent (3-4%) than would be expected from comparable small bowel resections [4, 5]. One reason for this could be that, over time, desquamated mucosal cell material accumulates as cell detritus in the distal ileum and leads to a mechanical obstruction of the intestinal lumen. Most likely at the level of the ileocecal valve/bauhin’s valve, after intestinal continuity has been restored. This is supported by the fact that a longer time interval between primary surgery and ileostomy resection leads to a higher rate of postoperative ileus and complications [4, 6]. Some time ago, we started to probe the aboral intestinal lumen with a latex/silicone foley’s catheter after resection of the small intestinal segment prior to anastomosis and then once flush it antegrade with 100 ml of physiological saline solution or anotherbalanced electrolyte solution (e.g. Ringer’s Lactate)to make the ileocecal valve passable. In the subjective perception of the surgeons involved, this procedure is associated with a lower rate of postoperative ileus and complications in general. Data on this procedure cannot be found in the international literature, so there is a need for prospective evaluation of this procedure.
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| Aim: |
The aim of this project is to compare standard ileostomy reversal (S-IR) without intraoperative antegrade bowel lavage with ileostomy reversal with intraoperative antegrade bowel lavage (ABL-IR) in a prospective randomized multicenter setting. The working hypothesis of this study is that postoperative bowel function - measured by the established endpoint Time-to-First-Flatus (TTFF) - will show earliernormalized bowel function postoperatively in the ABL-IR group than in the S-IR group. The superiority of the ABL-IR is also postulated for the secondary endpoints Time-to-First-Bowel-Movement (TTFBM), total complication rate according to the Clavien-Dindo classification [7], incidence of postoperative need for naso-gastric tube placement as well as the anastomosis insufficiency rate and re-operation rate. |
| Methods: |
The study is a prospective randomized intervention study with two study arms (Fig. 1). In the intervention arm, an antegrade bowel lavage of the "detached" ileum segment up to the ascending colon is performed during the ileostomy reversal. This will be done by probing the aboral bowel lumen with a foley catheter and flush this bowel segment with 100 ml of common intraoperative crystalloid whole electrolyte irrigation solution (e.g. Jonosteril or Ringer's lactate) or physiological saline solution (NaCl 0.9%) (ileostomy reversal with antegrade bowel lavage (ABL-IR)). The lavage should be done slowly, steadily and with slight retraction of the catheter during lavage. In the control arm, this bowel lavage is omitted (standard ileostomy retraction (S-IR)).
Randomization will be a 1:1 randomization with permuted blocks of variable size, which will be stratified for the participating centers.
Blinding of the surgical team is not possible for technical reasons. The follow-up of the patients after surgery and the recording of the postoperative findings will be carried out by additional medical study staff, who will remain blinded. The patient also remains blinded. The study is thus single-blinded.
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| Reason for International Trial: |
Primarly this trial was planned multicenter, nationwide. Surely international participation would result in faster recruitment and european-wide comparison of ileostomy reversal procedures. |