Delayed Small-Bowel Anastomosis in Patients With Postoperative Peritonitis

Anastomotic Leakage Clinical Trial

— Peritonitis  

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT03690687
• Other study ID #: Postoperative peritonitis
• Status: Active, not recruiting
• Start date: May 1, 2010
• Est. completion date: December 31, 2025

Study information

• Verified date: July 2021
• Source: Altai State Medical University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 114
• Est. completion date: December 31, 2025
• Est. primary completion date: December 1, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 19 Years to 76 Years

Eligibility

Inclusion Criteria:

• Clinical diagnosis of postoperastive peritonitis
• Conducting relaparotomy

Exclusion Criteria:

• Peritoneal cancer
• Multiple organ dysfunction syndrome

Related Conditions & MeSH terms

• Anastomotic Leak
• Anastomotic Leakage
• Intestinal Perforation
• Intestinal Perforation Small
• Peritonitis
• Postoperative Peritonitis

Intervention

Procedure:
• Primary anastomosis

• Delayed anastomosis

• Enterostomy

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Andrey Nikolayevich Zharikov

References & Publications (3)

Zharikov AN, Lubyansky VG, Aliev AR et al. Staged surgical treatment with temporary laparostomy in patients with postoperative peritonitis. Moscow Surgical Journal 1(41):10-14, 2015. URL: http://mossj.ru/journal/MOSSJ_2015/MXG_2015_01.pdf

Zharikov AN, Lubyansky VG, Aliev AR. Surgical techniques for open abdomen in patients with postoperative peritonitis. Bulletin of Medical Science 2(10):76-80, 2018. URL: http://www.agmu.ru/files/%E2%84%962(10)2018.pdf

Zharikov AN, Lubyansky VG, Zharikov AA. A differentiated approach to repeat small-bowel anastomoses in patients with postoperative peritonitis: a prospective cohort study. Eur J Trauma Emerg Surg. 2020 Oct;46(5):1055-1061. doi: 10.1007/s00068-019-01084-7. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of Patients with recurrent anastomotic leakage	Number of patients in groups 1 and 2	up to 2 months