Predictors of Laparoscopy Conversion in Adhesive Small Bowel Obstruction

Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorAlmazov National Medical Research Centre

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 volunteers

Qualifiers

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

Design model

Case-control

Time perspective

Retrospective

Treatments tested in this trial

  • Laparoscopic adhesiolysis

    Procedure/Surgery

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

  • Laparotomic adhesiolysis

    Procedure/Surgery

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

Treatment groups

170 Participants
are divided into 2 treatment groups
Group A: Laparoscopy group1 intervention
Group B: Conversion group1 intervention

Trial outcomes

Primary outcomes

1

Rate of succesfull laparoscopic interventions

The ratio of successful laparoscopic interventions to the total number of operations

Time frame
At the discharge from the hospital (assessed up to 10 days)

Secondary outcomes

1

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.

Time frame
Perioperative
2

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.

Time frame
Perioperative
3

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.

Time frame
Perioperative
4

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.

Time frame
Perioperative

Other outcomes

Sponsors and contacts

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