NCT03690687

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).

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
114

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started May 2010

Longer than P75 for all trials

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2010

Completed
8.4 years until next milestone

First Submitted

Initial submission to the registry

September 26, 2018

Completed
5 days until next milestone

First Posted

Study publicly available on registry

October 1, 2018

Completed
7.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2025

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2025

Completed
Last Updated

July 26, 2021

Status Verified

July 1, 2021

Enrollment Period

15.6 years

First QC Date

September 26, 2018

Last Update Submit

July 20, 2021

Conditions

Keywords

Surgical AnastomosisEnterostomyMortalityMorbidityAbdominal Closure TechniquesAPACHE IISecondary PeritonitisDelayed AnastomosisPrimary AnastomosisMannheim Peritonitis Index

Outcome Measures

Primary Outcomes (1)

  • Number of Patients with recurrent anastomotic leakage

    Number of patients in groups 1 and 2

    up to 2 months

Study Arms (3)

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

Interventions

Group I. Primary anastomosis
Group II. Delayed anastomosis
EnterostomyPROCEDURE
Group III. Enterostomy

Eligibility Criteria

Age19 Years - 76 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-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

You may qualify if:

  • Clinical diagnosis of postoperastive peritonitis
  • Conducting relaparotomy

You may not qualify if:

  • Peritoneal cancer
  • Multiple organ dysfunction syndrome

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (3)

  • 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

    BACKGROUND
  • 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

    BACKGROUND
  • 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.

MeSH Terms

Conditions

Anastomotic LeakPeritonitis

Interventions

Enterostomy

Condition Hierarchy (Ancestors)

Postoperative ComplicationsPathologic ProcessesPathological Conditions, Signs and SymptomsIntraabdominal InfectionsInfectionsPeritoneal DiseasesDigestive System Diseases

Intervention Hierarchy (Ancestors)

Digestive System Surgical ProceduresSurgical Procedures, OperativeOstomy

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

September 26, 2018

First Posted

October 1, 2018

Study Start

May 1, 2010

Primary Completion

December 1, 2025

Study Completion

December 31, 2025

Last Updated

July 26, 2021

Record last verified: 2021-07

Data Sharing

IPD Sharing
Will not share

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.