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Predictors of Laparoscopy Conversion in Adhesive Small Bowel Obstruction

Predictors of Laparoscopy Conversion in the Treatment of Adhesive Small Bowel Obstruction

Status
Not yet recruiting
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT07350447
Enrollment
170
Registered
2026-01-20
Start date
2026-01-01
Completion date
2026-05-31
Last updated
2026-01-20

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Adhesive Small Bowel Obstruction

Keywords

Adhesive small bowel obstruction, Ahesiolysis, Laparoscopic adhesiolysis, abdominal adhesions

Brief 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 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.

Interventions

Dissection of intra-abdominal adhesions performed laparoscopically in accordance with the principles adopted in the medical institution.

PROCEDURELaparotomic adhesiolysis

Traditional adhesiolysis, performed via laparotomy after unsuccessfull attempt of endovideosurgical approach.

Sponsors

Almazov National Medical Research Centre
Lead SponsorOTHER

Study design

Observational model
CASE_CONTROL
Time perspective
RETROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Rate of succesfull laparoscopic interventionsAt the discharge from the hospital (assessed up to 10 days)The ratio of successful laparoscopic interventions to the total number of operations

Secondary

MeasureTime frameDescription
Diameter of intestinal loopsPerioperativeDiameter 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.
Known or suspected complex adhesive processPerioperativePresence 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.
Number of laparotomy operationsPerioperativeNumber 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.
Ischemia or necrosis of the intestinePerioperativeIschemia 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.
Obstruction levelPerioperativeObstruction 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.
Duration of acute intestinal obstructionPerioperativeDuration 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.
Time of day at the start of the surgical interventionPerioperativeTime 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.

Countries

Russia

Contacts

CONTACTPavel A Kotkov, MD
Kotkovdr@mail.ru+79062619231
CONTACTBadri V Sigua, MD
dr.sigua@gmail.com
PRINCIPAL_INVESTIGATORPavel А Kotkov, MD

Almazov National Medical Research Centre

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026