NCT03139149

Brief Summary

This study will compare the results of early surgery after 12 h conservative treatment and 48 h conservative treatment of adhesive small bowel obstruction.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
200

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Oct 2017

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

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

First Submitted

Initial submission to the registry

March 30, 2017

Completed
1 month until next milestone

First Posted

Study publicly available on registry

May 3, 2017

Completed
5 months until next milestone

Study Start

First participant enrolled

October 11, 2017

Completed
6.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 30, 2024

Completed
8 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2024

Completed
Last Updated

March 30, 2023

Status Verified

March 1, 2023

Enrollment Period

6.6 years

First QC Date

March 30, 2017

Last Update Submit

March 29, 2023

Conditions

Small Bowel ObstructionSmall Bowel AdhesionStrangulation of Ileum

Keywords

conservative treatmentlaparoscopic adhesiolysisstrangulation

Outcome Measures

Primary Outcomes (1)

  • Quantity of patients with obstruction release after conservative treatment

    No of patients with success of conservative treatment

    in the 2nd group - 48 hours

Secondary Outcomes (4)

  • Readmission rate in conservative treatment and surgery

    12 months

  • 30 days mortality

    30 days

  • Complications rate

    30 days

  • Quantity of bowel resection

    156 hours

Study Arms (2)

Early surgery

ACTIVE COMPARATOR

After exclusion of indications for an emergency operation, conservative treatment is performed up to 12 hours from the moment of admission. Each patient receive blood test, blood lactate investigation, blood biochemistry, X-ray of the abdomen, ultrasound and CT on the admission. Each patient receive water-soluble contrast in 3 h after admission. In case of of clinical and radiologic signs of obstruction in 12 h after admission, surgery is performed. On the first stage of surgical treatment laparoscopic adhesiolysis is performed. If it is impossible to eliminate the cause of obstruction by laparoscopic technique laparotomy is performed.

Procedure: AdhesiolysisRadiation: X-ray diagnosticsRadiation: Computer tomographyProcedure: UltrasoundOther: General and biochemical blood test

Late surgery

ACTIVE COMPARATOR

After exclusion of indications for an emergency operation, conservative treatment is performed up to 48 hours from the moment of admission. Each patient receive blood test, blood lactate investigation, blood biochemistry, X-ray of the abdomen, ultrasound and CT on the admission. Each patient receive water-soluble contrast 3 h after admission. In case of present of obstruction and absence of contrast in colon in 36 h after intake (48 h after admission) a surgery is perform. On the first stage of surgical treatment laparoscopic adhesiolysis is performed. If it is impossible to eliminate the cause of obstruction by laparoscopic technique laparotomy is performed.

Procedure: AdhesiolysisRadiation: X-ray diagnosticsRadiation: Computer tomographyProcedure: UltrasoundOther: General and biochemical blood test

Interventions

AdhesiolysisPROCEDURE

Method of video laparoscopic operation: * Open access in the left upper quadrant of the anterior abdominal wall, * Installation of trocars, depending on the prevalence of the adhesion process * Assessment of the peritoneal adhesion index * Detection of the asleep gut * Detection of obstacle area * Removing the obstacle without trying to completely eliminate the adhesion process in the abdominal cavity If there is no possibility to eliminate the cause of intestinal obstruction laparoscopically laparotomy is performed.

Early surgeryLate surgery
X-ray diagnosticsRADIATION

X-ray of the thoracic (1) and abdomen (2-5 times) with water soluble contrast.

Early surgeryLate surgery
Computer tomographyRADIATION

Computer tomography of abdomen with iv contrast

Early surgeryLate surgery
UltrasoundPROCEDURE

Ultrasound of the abdomen (2 times)

Early surgeryLate surgery
General and biochemical blood testOTHER

General blood test and biochemical blood test 2 times a day

Early surgeryLate surgery

Eligibility Criteria

Age17 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Patients with adhesive small bowel obstruction

You may not qualify if:

  • Early postoperative small bowel obstruction Irreducible hernia Strangulation or peritonitis symptoms Impairment of consciousness Unstable hemodynamics

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Moscow Clinical Hospital 1

Moscow, Russia

RECRUITING

MeSH Terms

Interventions

High-Energy Shock Waves

Intervention Hierarchy (Ancestors)

Ultrasonic WavesSoundRadiation, NonionizingRadiationPhysical Phenomena

Central Study Contacts

Alexander E Tyagunov, MD. Prof

CONTACT

+79165022324tyagunov1@mail.ru

Alexander V Sazhin, PhD

CONTACT

+79163904180Sazhin-AV@yandex.ru

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD. Prof

Study Record Dates

First Submitted

March 30, 2017

First Posted

May 3, 2017

Study Start

October 11, 2017

Primary Completion

April 30, 2024

Study Completion

December 31, 2024

Last Updated

March 30, 2023

Record last verified: 2023-03

Data Sharing

IPD Sharing
Will share

Locations

RU(1)