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UnknownNCT03690687

Delayed Small-Bowel Anastomosis in Patients With Postoperative Peritonitis

Delayed Small-Bowel Anastomosis in Patients With Postoperative Peritonitis Due to Nontraumatic Small-Bowel Perforation and Anastomotic Leak: Cohort Study

Status
Unknown
Phase
Study type
Observational
Enrollment
114 (actual)
Sponsor
Andrey Nikolayevich Zharikov · Academic / Other
Sex
All
Age
19 Years – 76 Years
Healthy volunteers
Not accepted

Summary

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).

Detailed description

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: * Resection of the small bowel to place primary anastomosis: resection of the small bowel to place primary anastomosis into small intestine or transverse colon were performed by routine practice during relaparotomy. * Resection of the small intestine to place delayed anastomosis: resection of the small bowel was performed by routine practice. 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 into small intestine or transverse colon was performed during the planned relaparotomy with arrested postoperative peritonitis. * Resection of the small intestine with enterostomy: resection of the small intestine was performed by routine practice. 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. 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.

Conditions

Interventions

TypeNameDescription
PROCEDUREPrimary anastomosis
PROCEDUREDelayed anastomosis
PROCEDUREEnterostomy

Timeline

Start date
2010-05-01
Primary completion
2025-12-01
Completion
2025-12-31
First posted
2018-10-01
Last updated
2021-07-26

Source: ClinicalTrials.gov record NCT03690687. Inclusion in this directory is not an endorsement.

Delayed Small-Bowel Anastomosis in Patients With Postoperative Peritonitis (NCT03690687) · Clinical Trials Directory