Postoperative PeritonitisPeritonitisNCT03690687
Delayed Small-Bowel Anastomosis in Patients With Postoperative Peritonitis
An observational study of Postoperative Peritonitis and Anastomotic Leakage, run by Andrey Nikolayevich Zharikov.
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… Read more about this study
- Who is it for?
- Ages 19 to 76 years
- Conditions the study is for
- Postoperative Peritonitis, Anastomotic Leakage, Intestinal Perforation Small
- What is being tested?
- Primary anastomosis, Delayed anastomosis and Enterostomy
- Type of treatment
- Surgery or procedure
- How many people
- 114 participants
- Where
- No sites listed yet
- Study dates
- 1 May 2010to 31 Dec 2025
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 19 to 76 years
- All sexes
- No healthy volunteers
- Adult, Older adult
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
Who may be able to join
- Clinical diagnosis of postoperastive peritonitis
- Conducting relaparotomy
Who cannot join
- Peritoneal cancer
- Multiple organ dysfunction syndrome
About this study
Official title: Delayed Small-Bowel Anastomosis in Patients With Postoperative Peritonitis Due to Nontraumatic Small-Bowel Perforation and Anastomotic Leak: Cohort Study
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).
Read the 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.
- Being tested
- Primary anastomosis, Delayed anastomosis, Enterostomy
- Keywords
- Surgical Anastomosis, Enterostomy, Mortality, Morbidity, Abdominal Closure Techniques, APACHE II, Secondary Peritonitis, Delayed Anastomosis, Primary Anastomosis, Mannheim Peritonitis Index
- Medical subject headings
- Anastomotic Leak, Peritonitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Primary anastomosisProcedure or surgery
Delayed anastomosisProcedure or surgery
EnterostomyProcedure or surgery
| Study group | Role | What they receive |
|---|---|---|
| Group I. Primary anastomosis | Resection of the small bowel to place primary anastomosis into small intestine or transverse colon during relaparotomy. Receives: 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. Receives: 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. Receives: Procedure: Enterostomy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Patients with recurrent anastomotic leakage
Number of patients in groups 1 and 2
Measured: up to 2 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Oct 2018
- Study start1 May 2010
- Primary completion1 Dec 2025 (estimated)
- Study completion31 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Postoperative PeritonitisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 114 participants (actual)
Sponsor and investigators
- Lead sponsor
- Andrey Nikolayevich Zharikov
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Andrey Nikolayevich Zharikov, Altai State Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03690687
- Sponsor's protocol ID
- Postoperative peritonitis
- Acronym
- Peritonitis
- Status last verified
- Jul 2021
- First submitted
- 26 Sep 2018
- Last updated
- 26 Jul 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: 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.
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.
PubMed 30719528
Study at a glance
From the registry record, last updated by the sponsor on 26 Jul 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Delayed Small-Bowel Anastomosis in Patients With Postoperative Peritonitis Due to Nontraumatic Small-Bowel Perforation and Anastomotic Leak: Cohort Study
- ClinicalTrials.gov ID
- NCT03690687
- Acronym / sponsor ID
- Peritonitis / Postoperative peritonitis
- Keywords
- Surgical Anastomosis, Enterostomy, Mortality, Morbidity, Abdominal Closure Techniques, APACHE II, Secondary Peritonitis, Delayed Anastomosis
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 114 participants (actual)
- Lead sponsor
- Andrey Nikolayevich ZharikovUniversity, hospital or other
- Study start
- 1 May 2010 (actual)
- Primary completion
- 1 Dec 2025 (estimated)
- Study completion
- 31 Dec 2025 (estimated)
- First posted
- 1 Oct 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Group I. Primary anastomosis | – | Procedure: Primary anastomosisResection of the small bowel to place primary anastomosis into small intestine or transverse colon during relaparotomy. |
| Group II. Delayed anastomosis | – | Procedure: Delayed anastomosisResection 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. |
| Group III. Enterostomy | – | Procedure: EnterostomyResection 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. |
Who may qualify
- Ages
- 19 to 76 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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
Key inclusion criteria (2 listed)
- Clinical diagnosis of postoperastive peritonitis
- Conducting relaparotomy
Key exclusion criteria (2 listed)
- Peritoneal cancer
- Multiple organ dysfunction syndrome
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Primary anastomosis | Procedure or surgery | Group I. Primary anastomosis |
| Delayed anastomosis | Procedure or surgery | Group II. Delayed anastomosis |
| Enterostomy | Procedure or surgery | Group III. Enterostomy |
Primary outcome
Number of Patients with recurrent anastomotic leakage
Time frame: up to 2 months
Number of patients in groups 1 and 2
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Jul 2021.
- BackgroundZharikov 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
- BackgroundZharikov 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
- Results publication: PubMed 30719528Zharikov 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.
- Individual participant dataSharing planned: No. 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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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of Postoperative Peritonitis and Anastomotic Leakage, run by Andrey Nikolayevich Zharikov.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 26 Jul 2021. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Patients with recurrent anastomotic leakage (time frame: up to 2 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03690687, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Jul 2021.