About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
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 population
Patients, operated in surgical departments of 4 different hospitals in Saint-Petersburg and one hospital in Perm, Kazan and Yekaterinburg respectively.
Trial design
Case-control
Retrospective
Treatments tested in this trial
Laparoscopic adhesiolysis
Procedure/SurgeryDissection of intra-abdominal adhesions performed laparoscopically in accordance with the principles adopted in the medical institution.
Laparotomic adhesiolysis
Procedure/SurgeryTraditional adhesiolysis, performed via laparotomy after unsuccessfull attempt of endovideosurgical approach.
Treatment groups
Trial outcomes
Primary outcomes
Rate of succesfull laparoscopic interventions
The ratio of successful laparoscopic interventions to the total number of operations
Secondary outcomes
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.
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.
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.
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.
Sponsors and contacts
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