Adhesive Small Bowel ObstructionNCT07350447
Predictors of Laparoscopy Conversion in Adhesive Small Bowel Obstruction
An observational study of Adhesive Small Bowel Obstruction, run by Almazov National Medical Research Centre at 7 sites in Russia.
Trial summary
The goal of this observational study is to reveal predictors of unsuccessfull laparoscopic intervention in adult patients with adhesive small bowel obstruction. The main question it aims to answer is: are there any strong predictors of laparoscopy conversion in patients with small bowel obstruction, caused by… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Adhesive Small Bowel Obstruction
- What is being tested?
- Laparoscopic adhesiolysis and Laparotomic adhesiolysis
- Type of treatment
- Surgery or procedure
- How many people
- 170 participants
- Where
- 7 sitesRussia
- Study dates
- 1 Jan 2026to 31 May 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients, operated in surgical departments of 4 different hospitals in Saint-Petersburg and one hospital in Perm, Kazan and Yekaterinburg respectively.
Who may be able to join
- 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
Who cannot join
- acute adhesive intestinal obstruction in the hernial sac
- pregnant in the third trimester
- patients with severe cardiovascular or respiratory failure
- patients with hemodynamic shock
Trial locations and contacts
7 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Badri V Sigua, MD contact
7 sites in 1 country
Russia7 sites
Kazan Federal University
Kazan'
Andrey Yu Anisimov, MD, +78432366802, AYAnisimov@kpfu.ru
City Clinical Hospital No. 4
Perm
Vladimir A Samarcev, MD, +73422121812, samarcev-v@mail.ru
Almazov National Medical Research Centre
Saint Petersburg
Badri V Sigua, MD, dr.sigua@gmail.com
Mariinskaya Hospital
Saint Petersburg
Ivan A Solov'yev, MD, ivsolov@yandex.ru
Saint-Petersburg I.I. Dzhanelidze research institute of emergency medicine
Saint Petersburg
Andrei E Demko, MD, demko@emergency.spb.ru
The City Hospital of the Holy Martyr Elizabeth
Saint Petersburg
Sergei V Petrov, MD, 8-800-700-86-69, psvsurg@mail.ru
City Clinical Hospital No. 40
Yekaterinburg
Evgenii V Nishnevich, MD, +73432436300, usma@usma.ru
About this study
Official title: Predictors of Laparoscopy Conversion in the Treatment of Adhesive Small Bowel Obstruction
The goal of this observational study is to reveal predictors of unsuccessfull laparoscopic intervention in adult patients with adhesive small bowel obstruction. The main question it aims to answer is: are there any strong predictors of laparoscopy conversion in patients with small bowel obstruction, caused by intraabdominal adhesions.
Read the 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.
- Conditions
- Adhesive Small Bowel Obstruction
- Being tested
- Laparoscopic adhesiolysis, Laparotomic adhesiolysis
- Keywords
- Adhesive small bowel obstruction, Ahesiolysis, Laparoscopic adhesiolysis, abdominal adhesions
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Laparoscopic adhesiolysisProcedure or surgery
Dissection of intra-abdominal adhesions performed laparoscopically in accordance with the principles adopted in the medical institution.
Laparotomic adhesiolysisProcedure or surgery
Traditional adhesiolysis, performed via laparotomy after unsuccessfull attempt of endovideosurgical approach.
| Study group | Role | What they receive |
|---|---|---|
| Laparoscopy group | Patients with acute adhesive intestinal obstruction, operated through surgical intervention, that was initiated and completed using endovideosurgical methods. Receives: Procedure: Laparoscopic adhesiolysis | |
| 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. Receives: Procedure: Laparotomic adhesiolysis |
What is being measured
The primary outcome is the main question the study is designed to answer.
Rate of succesfull laparoscopic interventions
The ratio of successful laparoscopic interventions to the total number of operations
Measured: At the discharge from the hospital (assessed up to 10 days)
Secondary outcomes (7)
Diameter of intestinal loops
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.
Measured: Perioperative
Known or suspected complex adhesive process
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.
Measured: Perioperative
Number of laparotomy operations
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.
Measured: Perioperative
Ischemia or necrosis of the intestine
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.
Measured: Perioperative
Obstruction level
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.
Measured: Perioperative
Duration of acute intestinal obstruction
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.
Measured: Perioperative
Time of day at the start of the surgical intervention
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.
Measured: Perioperative
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jan 2026
- Study start1 Jan 2026 (estimated)
- Primary completion30 Apr 2026 (estimated)
- Study completion31 May 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Adhesive Small Bowel ObstructionStudies 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
- Case-control
- Time perspective
- Retrospective
- Enrolment
- 170 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Almazov National Medical Research Centre
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Kotkov Pavel, Almazov National Medical Research Centre
- Investigators
- Pavel А Kotkov, MD, Principal investigator, Almazov National Medical Research Centre
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07350447
- Sponsor's protocol ID
- 14071979
- Status last verified
- Jan 2026
- First submitted
- 23 Dec 2025
- Last updated
- 20 Jan 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 20 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Predictors of Laparoscopy Conversion in the Treatment of Adhesive Small Bowel Obstruction
- ClinicalTrials.gov ID
- NCT07350447
- Acronym / sponsor ID
- 14071979
- Conditions
- Adhesive Small Bowel Obstruction
- Keywords
- Adhesive small bowel obstruction, Ahesiolysis, Laparoscopic adhesiolysis, abdominal adhesions
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 170 participants (estimated)
- Lead sponsor
- Almazov National Medical Research CentreUniversity, hospital or other
- Study start
- 1 Jan 2026 (estimated)
- Primary completion
- 30 Apr 2026 (estimated)
- Study completion
- 31 May 2026 (estimated)
- First posted
- 20 Jan 2026 (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.
The goal of this observational study is to reveal predictors of unsuccessfull laparoscopic intervention in adult patients with adhesive small bowel obstruction. The main question it aims to answer is: are there any strong predictors of laparoscopy conversion in patients with small bowel obstruction, caused by intraabdominal adhesions.
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 design
- Observational model
- Case-control
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Laparoscopy group | – | Procedure: Laparoscopic adhesiolysisPatients with acute adhesive intestinal obstruction, operated through surgical intervention, that was initiated and completed using endovideosurgical methods. |
| Conversion group | – | Procedure: Laparotomic adhesiolysisPatients 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients, operated in surgical departments of 4 different hospitals in Saint-Petersburg and one hospital in Perm, Kazan and Yekaterinburg respectively.
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (4 listed)
- acute adhesive intestinal obstruction in the hernial sac
- pregnant in the third trimester
- patients with severe cardiovascular or respiratory failure
- patients with hemodynamic shock
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 |
|---|---|---|
| Laparoscopic adhesiolysisDissection of intra-abdominal adhesions performed laparoscopically in accordance with the principles adopted in the medical institution. | Procedure or surgery | Laparoscopy group |
| Laparotomic adhesiolysisTraditional adhesiolysis, performed via laparotomy after unsuccessfull attempt of endovideosurgical approach. | Procedure or surgery | Conversion group |
Primary outcome
Rate of succesfull laparoscopic interventions
Time frame: At the discharge from the hospital (assessed up to 10 days)
The ratio of successful laparoscopic interventions to the total number of operations
7 secondary outcomes
Diameter of intestinal loops
Time frame: Perioperative
Known or suspected complex adhesive process
Time frame: Perioperative
Number of laparotomy operations
Time frame: Perioperative
Ischemia or necrosis of the intestine
Time frame: Perioperative
Obstruction level
Time frame: Perioperative
Duration of acute intestinal obstruction
Time frame: Perioperative
Time of day at the start of the surgical intervention
Time frame: Perioperative
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Jan 2026.
- Individual participant dataSharing planned: Undecided
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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.
Badri V Sigua, MD contact
Pavel А Kotkov, MD principal investigator
Almazov National Medical Research Centre
7 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Adhesive Small Bowel Obstruction, run by Almazov National Medical Research Centre at 7 sites in Russia.
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 3 inclusion and 4 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: opening soon, as of the sponsor's last update on 20 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 7 sites in Russia. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Pavel A Kotkov, MD (+79062619231, Kotkovdr@mail.ru), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Rate of succesfull laparoscopic interventions (time frame: At the discharge from the hospital (assessed up to 10 days)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 20 Jan 2026; AzTrials last refreshed its copy on 1 Nov 2026.