- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07350447
Predictors of Laparoscopy Conversion in Adhesive Small Bowel Obstruction
Predictors of Laparoscopy Conversion in the Treatment of Adhesive Small Bowel Obstruction
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Considering the undeniable advantages of laparoscopic interventions over laparotomic ones, the question of choosing a surgical approach in patients with acute adhesive intestinal obstruction can be reformulated as follows: in what situations is endovideosurgical intervention generally appropriate and feasible? A laparoscopic approach to severely distended bowel loops and widespread adhesions may increase the risk of serious complications. Indeed, some authors report intestinal injury in 6.3-26.9% of patients undergoing laparoscopic adhesiolysis for acute adhesive intestinal obstruction, which is statistically significantly higher than the same rate in patients operated on using a traditional approach. Therefore, a priority should be addressing the issue of adequately selecting patients who, based on a number of clinical indicators, are suitable for laparoscopic surgery or, at least, have no contraindications. While some parameters, such as acute cardiovascular or respiratory failure and pregnancy in the third trimester, can be defined as absolute contraindications to endovideosurgical access, a number of clinical and instrumental indicators are debatable. Despite the fact that this issue has been extensively covered in the literature, and the list of predictors of unsuccessful laparoscopic adhesiolysis is currently quite impressive, a standardized approach to access selection is lacking or is determined largely intuitively.
The aim of this work is to determine reliable anamnestic, clinical and instrumental signs that would indicate a high risk of conversion of the laparoscopic intervention in patients with acute adhesive intestinal obstruction.
The study is planned to be a multicenter, retrospective case-control study. Clinical data will be collected at four medical institutions in St. Petersburg. The medical records of patients who underwent emergency and urgent surgery for acute adhesive intestinal obstruction will be analyzed.
Study Type
Enrollment (Estimated)
Contacts and Locations
Study Contact
- Name: Pavel A Kotkov, MD
- Phone Number: +79062619231
- Email: Kotkovdr@mail.ru
Study Contact Backup
- Name: Badri V Sigua, MD
- Email: dr.sigua@gmail.com
Study Locations
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Kazan', Russia
- Kazan Federal University
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Contact:
- Andrey Yu Anisimov, MD
- Phone Number: +78432366802
- Email: AYAnisimov@kpfu.ru
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Perm, Russia
- City Clinical Hospital No. 4
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Contact:
- Vladimir A Samarcev, MD
- Phone Number: +73422121812
- Email: samarcev-v@mail.ru
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Saint Petersburg, Russia
- Almazov National Medical Research Centre
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Contact:
- Badri V Sigua, MD
- Email: dr.sigua@gmail.com
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Saint Petersburg, Russia
- Mariinskaya Hospital
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Contact:
- Ivan A Solov'yev, MD
- Email: ivsolov@yandex.ru
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Saint Petersburg, Russia
- Saint-Petersburg I.I. Dzhanelidze research institute of emergency medicine
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Contact:
- Andrei E Demko, MD
- Email: demko@emergency.spb.ru
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Saint Petersburg, Russia
- The City Hospital of the Holy Martyr Elizabeth
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Contact:
- Sergei V Petrov, MD
- Phone Number: 8-800-700-86-69
- Email: psvsurg@mail.ru
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Yekaterinburg, Russia
- City Clinical Hospital No. 40
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Contact:
- Evgenii V Nishnevich, MD
- Phone Number: +73432436300
- Email: usma@usma.ru
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
Inclusion Criteria:
- patients underwent emergency and urgent surgery for acute adhesive intestinal obstruction
- the surgery was performed laparoscopically
- the surgery was initiated laparoscopically and completed via laparotomy
Exclusion Criteria:
- acute adhesive intestinal obstruction in the hernial sac
- pregnant in the third trimester
- patients with severe cardiovascular or respiratory failure
- patients with hemodynamic shock
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
|
Laparoscopy group
Patients with acute adhesive intestinal obstruction, operated through surgical intervention, that was initiated and completed using endovideosurgical methods.
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Dissection of intra-abdominal adhesions performed laparoscopically in accordance with the principles adopted in the medical institution.
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Conversion group
Patients with acute adhesive intestinal obstruction, in whom surgical intervention was initiated by endovideosurgical means, however, during the operation there was a need for laparotomy and the surgical procedure was completed by laparotomy access.
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Traditional adhesiolysis, performed via laparotomy after unsuccessfull attempt of endovideosurgical approach.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Rate of succesfull laparoscopic interventions
Time Frame: At the discharge from the hospital (assessed up to 10 days)
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The ratio of successful laparoscopic interventions to the total number of operations
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At the discharge from the hospital (assessed up to 10 days)
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Diameter of intestinal loops
Time Frame: Perioperative
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Diameter of intestinal loops (cm), ascertained during X-ray treatment before the operation.
The correlation between this outcome and the likelihood of unsuccessful laparoscopic adhesiolysis and the need for laparotomy will be studied.
The power of corellation will be measured according to the Spearman correlation coefficient and relative risk with a 95% confidence interval.
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Perioperative
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Known or suspected complex adhesive process
Time Frame: Perioperative
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Presence of known or suspected complex adhesive process (according to anamnestic data).
The correlation between this outcome and the likelihood of unsuccessful laparoscopic adhesiolysis and the need for laparotomy will be studied.
The power of corellation will be measured according to the Spearman correlation coefficient and relative risk with a 95% confidence interval.
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Perioperative
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Number of laparotomy operations
Time Frame: Perioperative
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Number of laparotomy operations according to anamnestic data.
The correlation between this outcome and the likelihood of unsuccessful laparoscopic adhesiolysis and the need for laparotomy will be studied.
The power of corellation will be measured according to the Spearman correlation coefficient and relative risk with a 95% confidence interval.
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Perioperative
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Ischemia or necrosis of the intestine
Time Frame: Perioperative
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Ischemia or necrosis of the intestine, requiring resection (diagnosed intraoperatively).
The correlation between this outcome and the likelihood of unsuccessful laparoscopic adhesiolysis and the need for laparotomy will be studied.
The power of corellation will be measured according to the Spearman correlation coefficient and relative risk with a 95% confidence interval.
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Perioperative
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Obstruction level
Time Frame: Perioperative
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Obstruction level measured in cm from Treitz ligament to obstruction site, diagnosed intraoperatively.
The correlation between this outcome and the likelihood of unsuccessful laparoscopic adhesiolysis and the need for laparotomy will be studied.
The power of corellation will be measured according to the Spearman correlation coefficient and relative risk with a 95% confidence interval.
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Perioperative
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Duration of acute intestinal obstruction
Time Frame: Perioperative
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Duration of acute intestinal obstruction, measured in hours from pain onset till surgery.
The correlation between this outcome and the likelihood of unsuccessful laparoscopic adhesiolysis and the need for laparotomy will be studied.
The power of corellation will be measured according to the Spearman correlation coefficient and relative risk with a 95% confidence interval.
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Perioperative
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Time of day at the start of the surgical intervention
Time Frame: Perioperative
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Time of day at the start of the surgical intervention, specified as daytime (from 9:00 to 18:00), evening (from 18:00 to 24:00), night (from 24:00 to 9:00).
The correlation between this outcome and the likelihood of unsuccessful laparoscopic adhesiolysis and the need for laparotomy will be studied.
The power of corellation will be measured according to the Spearman correlation coefficient and relative risk with a 95% confidence interval.
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Perioperative
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Collaborators and Investigators
Investigators
- Principal Investigator: Pavel А Kotkov, MD, Almazov National Medical Research Centre
Study record dates
Study Major Dates
Study Start (Estimated)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- 14071979
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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