NCT07350447

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.

Trial Health

63
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Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
170

participants targeted

Target at P50-P75 for all trials

Timeline
1mo left

Started Jan 2026

Shorter than P25 for all trials

Geographic Reach
1 country

7 active sites

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress85%
Jan 2026May 2026

First Submitted

Initial submission to the registry

December 23, 2025

Completed
9 days until next milestone

Study Start

First participant enrolled

January 1, 2026

Completed
19 days until next milestone

First Posted

Study publicly available on registry

January 20, 2026

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 30, 2026

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

May 31, 2026

Expected
Last Updated

January 20, 2026

Status Verified

January 1, 2026

Enrollment Period

4 months

First QC Date

December 23, 2025

Last Update Submit

January 10, 2026

Conditions

Keywords

Adhesive small bowel obstructionAhesiolysisLaparoscopic adhesiolysisabdominal adhesions

Outcome Measures

Primary Outcomes (1)

  • Rate of succesfull laparoscopic interventions

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

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

Secondary Outcomes (7)

  • Diameter of intestinal loops

    Perioperative

  • Known or suspected complex adhesive process

    Perioperative

  • Number of laparotomy operations

    Perioperative

  • Ischemia or necrosis of the intestine

    Perioperative

  • Obstruction level

    Perioperative

  • +2 more secondary outcomes

Study Arms (2)

Laparoscopy group

Patients with acute adhesive intestinal obstruction, operated through surgical intervention, that was initiated and completed using endovideosurgical methods.

Procedure: Laparoscopic adhesiolysis

Conversion group

Patients with acute adhesive intestinal obstruction, in whom surgical intervention was initiated by endovideosurgical means, however, during the operation there was a need for laparotomy and the surgical procedure was completed by laparotomy access.

Procedure: Laparotomic adhesiolysis

Interventions

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

Laparoscopy group

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

Conversion group

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients, operated in surgical departments of 4 different hospitals in Saint-Petersburg and one hospital in Perm, Kazan and Yekaterinburg respectively.

You may qualify if:

  • 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

You may not qualify if:

  • acute adhesive intestinal obstruction in the hernial sac
  • pregnant in the third trimester
  • patients with severe cardiovascular or respiratory failure
  • patients with hemodynamic shock

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (7)

Kazan Federal University

Kazan', Russia

Location

City Clinical Hospital No. 4

Perm, Russia

Location

Almazov National Medical Research Centre

Saint Petersburg, Russia

Location

Mariinskaya Hospital

Saint Petersburg, Russia

Location

Saint-Petersburg I.I. Dzhanelidze research institute of emergency medicine

Saint Petersburg, Russia

Location

The City Hospital of the Holy Martyr Elizabeth

Saint Petersburg, Russia

Location

City Clinical Hospital No. 40

Yekaterinburg, Russia

Location

Study Officials

  • Pavel А Kotkov, MD

    Almazov National Medical Research Centre

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Pavel A Kotkov, MD

CONTACT

Badri V Sigua, MD

CONTACT

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant professor of the general surgery department

Study Record Dates

First Submitted

December 23, 2025

First Posted

January 20, 2026

Study Start

January 1, 2026

Primary Completion

April 30, 2026

Study Completion (Estimated)

May 31, 2026

Last Updated

January 20, 2026

Record last verified: 2026-01

Locations