An observational study in Postoperative Peritonitis, Anastomotic Leakage and Intestinal Perforation Small, sponsored by Andrey Nikolayevich Zharikov. Active, not recruiting. Open to participants aged 19 Years to 76 Years. Per ClinicalTrials.gov, last updated 2021-07-26.
Sponsored by Andrey Nikolayevich Zharikov · Observational
Surgical management results for 114 patients with postoperative peritonitis due to small-bowel perforations, necrosis, and anastomotic leakage were comparatively analyzed. Using the APACHE-II (Acute Physiology, Age, Chronic Health Evaluation) and MPI (Mannheim Peritonitis Index) scoring systems, different surgical approaches were examined in three patient groups (primary anastomosis, delayed anastomosis, and enterostomy).
One hundred and fourteen (114) participants with postoperative peritonitis resulted from small-bowel perforations or small-bowel anastomotic leaks were divided prior to surgery into 3 groups following the APACHE-II (Acute Physiology, Age, Chronic Health Evaluation) and MPI (Mannheim Peritonitis Index) scores, and different surgical approaches were applied to the groups: group I underwent resection of the small intestine to place primary anastomosis; group II was subjected to resection of the small intestine to place delayed anastomosis; and group III went through resection of the small intestine with enterostomy. The surgeon used minimization (including a random element) and stratification by gender, age, and small-bowel pathology.
The patients received resection of the small bowel to place primary small-bowel anastomosis, or as depending on their grouping:
The specificity of each operation, including a decision to make changes in the planned anastomosis after assessing the severity of illness and the severity of postoperative peritonitis, was at the discretion of the surgeon.
All of the patients were followed up after operations. The patients were supervised in the clinic for 60 days post-surgery. During the postoperative period, complications in the three patient groups were assessed in terms of newly emerged small-bowel perforations, the number of anastomotic leaks, the number of programmed relaparotomies and on-demand relaparotomies, and mortality rate.
240 studies on the registry are indexed under Anastomotic Leak; 72 are open to participants now.
This study's enrollment of 114 is below the median of 166 across 111 observational studies indexed under Anastomotic Leak.
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Local patients admitted to the clinic from around Altai Krai cities, suffering from postoperative peritonitis due to small-bowel perforations and small-bowel anastomotic leaks
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Exclusion Criteria:
Resection of the small bowel to place primary anastomosis into small intestine or transverse colon during relaparotomy.
Procedure: Primary anastomosis
Resection of the small intestine to place delayed anastomosis. After the closure of the afferent and efferent loops of the small intestine, anastomosis was not applied. A decompression probe was introduced into the upper small intestine. In 24-36 hours, delayed anastomosis was placed into the small intestine or transverse colon during the planned relaparotomy with arrested postoperative peritonitis.
Procedure: Delayed anastomosis
Resection of the small intestine with enterostomy. In case there was no postoperative peritonitis relief and was organ dysfunction progression, anastomosis was not placed. The surgery was completed with enterostomy to perform open abdomen.
Procedure: Enterostomy
Number of Patients with recurrent anastomotic leakage
Number of patients in groups 1 and 2
Time frame: up to 2 months
No study locations are listed for this record.
Plan to share: No — The first group included 47 patients (41.2%) who underwent conventional surgical management during relaparotomy, taking into account APACHE-II severity of illness and MPI severity of peritonitis. This surgical treatment involved suturing the intestinal wall defects or small-bowel resection to place primary anastomosis. The second patient group included 55 patients (48.2%) to which the delayed anastomosis technique was applied during relaparotomy, taking account the APACHE-II and MPI scores. The third patient group included 12 patients (10.5%) who had the highest risk of small-bowel suture failure when closing the defects in either primary or delayed anastomosis, as well as the risk of new small-bowel perforations to occur. In these cases, resection of the intestine was performed with enterostomy, along with planned relaparotomies and Open Abdomen management.
This study is active, not recruiting, as verified in Jul 2021. You cannot join it, but the record below documents what was studied.
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