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Delayed Small-Bowel Anastomosis in Patients With Postoperative Peritonitis (Peritonitis)

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ClinicalTrials.gov Identifier: NCT03690687
Recruitment Status : Active, not recruiting
First Posted : October 1, 2018
Last Update Posted : July 26, 2021
Sponsor:
Information provided by (Responsible Party):
Andrey Nikolayevich Zharikov, Altai State Medical University

Study Description
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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).

Condition or disease Intervention/treatment
Postoperative Peritonitis Anastomotic Leakage Intestinal Perforation Small Procedure: Primary anastomosis Procedure: Delayed anastomosis Procedure: 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 Design
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Study Type : Observational
Actual Enrollment : 114 participants
Observational Model: Cohort
Time Perspective: Cross-Sectional
Official Title: Delayed Small-Bowel Anastomosis in Patients With Postoperative Peritonitis Due to Nontraumatic Small-Bowel Perforation and Anastomotic Leak: Cohort Study
Actual Study Start Date : May 1, 2010
Estimated Primary Completion Date : December 1, 2025
Estimated Study Completion Date : December 31, 2025
Groups and Cohorts
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Group/Cohort Intervention/treatment
Group I. Primary anastomosis
Resection of the small bowel to place primary anastomosis into small intestine or transverse colon during relaparotomy.
 Procedure: Primary anastomosis
Group II. 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.
 Procedure: Delayed anastomosis
Group III. 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.
 Procedure: Enterostomy


Outcome Measures
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Primary Outcome Measures :
  1. Number of Patients with recurrent anastomotic leakage [ Time Frame: up to 2 months ]
    Number of patients in groups 1 and 2


Eligibility Criteria
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Information from the National Library of Medicine

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Ages Eligible for Study:   19 Years to 76 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
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
Criteria

Inclusion Criteria:

  • Clinical diagnosis of postoperastive peritonitis
  • Conducting relaparotomy

Exclusion Criteria:

  • Peritoneal cancer
  • Multiple organ dysfunction syndrome
Contacts and Locations
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No Contacts or Locations Provided
More Information
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Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information
Publications of Results:

Other Publications:
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, 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

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Responsible Party: Andrey Nikolayevich Zharikov, Professor, Altai State Medical University
ClinicalTrials.gov Identifier: NCT03690687    
Other Study ID Numbers: Postoperative peritonitis
First Posted: October 1, 2018    Key Record Dates
Last Update Posted: July 26, 2021
Last Verified: July 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: 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.

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Andrey Nikolayevich Zharikov, Altai State Medical University:
Surgical Anastomosis
Enterostomy
Mortality
Morbidity
Abdominal Closure Techniques
 APACHE II
Secondary Peritonitis
Delayed Anastomosis
Primary Anastomosis
Mannheim Peritonitis Index
Additional relevant MeSH terms:
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Peritonitis
Intestinal Perforation
Anastomotic Leak
Intraabdominal Infections
Infections
Peritoneal Diseases
 Digestive System Diseases
Postoperative Complications
Pathologic Processes
Intestinal Diseases
Gastrointestinal Diseases