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

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

Tracking Information

• First Submitted Date: September 26, 2018
• First Posted Date: October 1, 2018
• Last Update Posted Date: July 26, 2021
• Actual Study Start Date: May 1, 2010
• Estimated Primary Completion Date: December 1, 2025 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: September 28, 2018)

Number of Patients with recurrent anastomotic leakage [ Time Frame: up to 2 months ]

Number of patients in groups 1 and 2

Original Primary Outcome Measures (submitted: September 27, 2018)

• Primary anastomosis implications [ Time Frame: up to 3 months ]
  New small-bowel perforations, recurrent anastomotic leakage, mortality
• Delayed anastomosis implications [ Time Frame: up to 3 months ]
  New small-bowel perforations, recurrent anastomotic leakage, mortality
• Enterostomy implications [ Time Frame: up to 3 months ]
  New small-bowel perforations, recurrent anastomotic leakage, mortality

• Current Secondary Outcome Measures: Not Provided
• Original Secondary Outcome Measures: Not Provided
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: Delayed Small-Bowel Anastomosis in Patients With Postoperative Peritonitis
• Official Title: Delayed Small-Bowel Anastomosis in Patients With Postoperative Peritonitis Due to Nontraumatic Small-Bowel Perforation and Anastomotic Leak: Cohort Study
• 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 Type: Observational
• Study Design: Observational Model: Cohort; Time Perspective: Cross-Sectional
• Target Follow-Up Duration: Not Provided
• Biospecimen: Not Provided
• 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

Condition

• Postoperative Peritonitis
• Anastomotic Leakage
• Intestinal Perforation Small

Intervention

• Procedure: Primary anastomosis
• Procedure: Delayed anastomosis
• Procedure: Enterostomy

Study Groups/Cohorts

• Group I. Primary anastomosis
  Resection of the small bowel to place primary anastomosis into small intestine or transverse colon during relaparotomy.
  Intervention: 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.
  Intervention: 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.
  Intervention: Procedure: Enterostomy

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
• 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. Epub 2019 Feb 4.

Recruitment Information

• Recruitment Status: Active, not recruiting
• Actual Enrollment (submitted: September 27, 2018): 114
• Original Actual Enrollment: Same as current
• Estimated Study Completion Date: December 31, 2025
• Estimated Primary Completion Date: December 1, 2025 (Final data collection date for primary outcome measure)

Eligibility Criteria

Inclusion Criteria:

• Clinical diagnosis of postoperastive peritonitis
• Conducting relaparotomy

Exclusion Criteria:

• Peritoneal cancer
• Multiple organ dysfunction syndrome

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 19 Years to 76 Years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: Not Provided

Administrative Information

• NCT Number: NCT03690687
• Other Study ID Numbers: Postoperative peritonitis
• Has Data Monitoring Committee: No

U.S. FDA-regulated Product

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

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.

• Current Responsible Party: Andrey Nikolayevich Zharikov, Altai State Medical University
• Original Responsible Party: Same as current
• Current Study Sponsor: Andrey Nikolayevich Zharikov
• Original Study Sponsor: Same as current
• Collaborators: Not Provided
• Investigators: Not Provided
• PRS Account: Altai State Medical University
• Verification Date: July 2021