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NCT Number: NCT07350447

Predictors of Laparoscopy Conversion in 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.

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Key information

Conditions

Adhesive Small Bowel Obstruction

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Kazan Federal University, Kazan', Russia

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Laparoscopic adhesiolysis

Procedure

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

Laparotomic adhesiolysis

Procedure

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

Primary outcomes

  1. 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

Secondary outcomes

  1. Diameter of intestinal loops

    Time frame: Perioperative

    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.

  2. Known or suspected complex adhesive process

    Time frame: Perioperative

    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.

  3. Number of laparotomy operations

    Time frame: Perioperative

    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.

  4. Ischemia or necrosis of the intestine

    Time frame: Perioperative

    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.

  5. Obstruction level

    Time frame: Perioperative

    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.

  6. Duration of acute intestinal obstruction

    Time frame: Perioperative

    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.

  7. Time of day at the start of the surgical intervention

    Time frame: Perioperative

    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.

Study contacts

Contact information is provided by the study sponsor or research team.

Badri V Sigua, MD

CONTACT

[email protected]

Pavel A Kotkov, MD

CONTACT

[email protected]

+79062619231

Sponsors and collaborators

Lead sponsor

Almazov National Medical Research Centre

Other

Registry information

Official study title

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

Important dates

Study start
2026
Primary completion
2026
Study completion
2026
First posted
Jan 20, 2026
Registry last updated
Jan 20, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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