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Predictors of Laparoscopy Conversion in Adhesive Small Bowel Obstruction

Observational Adhesive Small Bowel Obstruction

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Laparoscopic adhesiolysis, Laparotomic adhesiolysis.
Who it may be relevant to
Registry conditions: Adhesive Small Bowel Obstruction. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Russia
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Official title

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

Overview

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

  • Procedure Laparoscopic adhesiolysis
    Dissection of intra-abdominal adhesions performed laparoscopically in accordance with the principles adopted in the medical institution.
  • Procedure Laparotomic adhesiolysis
    Traditional adhesiolysis, performed via laparotomy after unsuccessfull attempt of endovideosurgical approach.

Primary outcome measures

  • Rate of succesfull laparoscopic interventions [Time frame: At the discharge from the hospital (assessed up to 10 days)]
Secondary outcome measures (7)
  • 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]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model
Case-control

Study locations

Russia · 7 centers
  • Kazan Federal University — Kazan'
  • City Clinical Hospital No. 4 — Perm
  • Almazov National Medical Research Centre — Saint Petersburg
  • Mariinskaya Hospital — Saint Petersburg
  • Saint-Petersburg I.I. Dzhanelidze research institute of emergency medicine — Saint Petersburg
  • The City Hospital of the Holy Martyr Elizabeth — Saint Petersburg
  • City Clinical Hospital No. 40 — Yekaterinburg

Identifiers

NCT: NCT07350447 · 14071979

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗