Delayed Small-Bowel Anastomosis in Patients With Postoperative Peritonitis

Active, not recruiting

• Conditions: Anastomotic Leakage; Intestinal Perforation Small; Postoperative Peritonitis
• Interventions: Procedure: Primary anastomosis; Procedure: Enterostomy; Procedure: Delayed anastomosis

• Registration Number: NCT03690687
• Lead Sponsor: Andrey Nikolayevich Zharikov

Brief 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.

Study Timeline

• Study Start: 2010-05-01
• Study First Submitted: 2018-09-26
• Study First Submitted QC: 2018-09-27
• Study First Posted: 2018-10-01
• Status Verified: 2021-07
• Last Update Submitted: 2021-07-20
• Last Update Posted: 2021-07-26
• Primary Completion: 2025-12-01
• Study Completion: 2025-12-31

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 114

Inclusion Criteria

• Clinical diagnosis of postoperastive peritonitis
• Conducting relaparotomy

Exclusion Criteria

• Peritoneal cancer
• Multiple organ dysfunction syndrome

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Group I. Primary anastomosis	Primary anastomosis	Resection of the small bowel to place primary anastomosis into small intestine or transverse colon during relaparotomy.
Group III. Enterostomy	Enterostomy	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.
Group II. Delayed anastomosis	Delayed 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.

Primary Outcome Measures

Name	Time	Method
Number of Patients with recurrent anastomotic leakage	up to 2 months	Number of patients in groups 1 and 2