Short and Prolonged Conservative Treatment in Patients With Adhesive Intestinal Obstruction

NCT ID: NCT05841069

Last Updated: 2023-05-03

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

180 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-01-01

Study Completion Date

2024-02-01

Brief Summary

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This study will compare the results of 24 h conservative treatment and N h conservative treatment of adhesive small bowel obstruction (where N = 72 h minus duration of intestinal obstruction).

Detailed Description

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Patients with acute adhesive intestinal obstruction, who dont need an emergency operation, will be given water insoluble contrast per os and randomized into two groups - early and delayed surgery. The first group will receive conservative treatment within no more than 24 h. Duration of non-operative treatment in second group will be 72 h minus duration of intestinal obstruction, based on the onset of symptoms. In both groups surgery will be performed if contrast will not reach colon in mentioned terms or clinical deterioration signs will appear. The results of 24 h conservative treatment and N h conservative treatment (where N = 72 h minus duration of intestinal obstruction) will be compared.

Conditions

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Small Bowel Obstruction Small Bowel Adhesion

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Multicenter controlled randomized prospective study
Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

No masking is expected due to the nature of interventions

Study Groups

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Short conservative treatment

Conservative treatment will be performed within no more than 24 h. Surgery will be performed in the absence of contrast in colon according to X-ray examination and if signs of clinical degradation will appear.

Group Type ACTIVE_COMPARATOR

Adhesiolysis

Intervention Type PROCEDURE

Median laparotomy with subsequent detection of intestinal obstruction cause and adhesiolysis.

X-ray examination

Intervention Type RADIATION

Plain X-ray of abdomen (1-4 times) with water insoluble contrast.

Conservative treatment

Intervention Type PROCEDURE

A set of measures aimed at non-operative resolution of acute intestinal obstruction - nasogastric tube, infusion therapy.

Prolonged conservative treatment

Conservative treatment will be performed within N h, where N = 72 h minus duration of acute intestinal obstruction. Surgery will be performed in the absence of contrast in colon according to X-ray examination and if signs of clinical degradation will appear.

Group Type EXPERIMENTAL

Adhesiolysis

Intervention Type PROCEDURE

Median laparotomy with subsequent detection of intestinal obstruction cause and adhesiolysis.

X-ray examination

Intervention Type RADIATION

Plain X-ray of abdomen (1-4 times) with water insoluble contrast.

Conservative treatment

Intervention Type PROCEDURE

A set of measures aimed at non-operative resolution of acute intestinal obstruction - nasogastric tube, infusion therapy.

Interventions

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Adhesiolysis

Median laparotomy with subsequent detection of intestinal obstruction cause and adhesiolysis.

Intervention Type PROCEDURE

X-ray examination

Plain X-ray of abdomen (1-4 times) with water insoluble contrast.

Intervention Type RADIATION

Conservative treatment

A set of measures aimed at non-operative resolution of acute intestinal obstruction - nasogastric tube, infusion therapy.

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

* patients with acute intestinal obstruction

Exclusion Criteria

* pregnancy;
* peritonitis or strangulation, revealed during primary examination;
* early acute small bowel obstruction (presence of anamnestic surgical intervention within 6 month)
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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North-Western State Medical University named after I.I.Mechnikov

OTHER

Sponsor Role lead

Responsible Party

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Kotkov Pavel

PhD, surgery department assistant

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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26 City Hospital

Saint Petersburg, , Russia

Site Status RECRUITING

North-Western State Medical University named after I. I. Mechnikov

Saint Petersburg, , Russia

Site Status RECRUITING

Saint-Petersburg I.I. Dzhanelidze Research Institute of Emergency Medicine

Saint Petersburg, , Russia

Site Status RECRUITING

The City Hospital of the Holy Martyr Elizabeth

Saint Petersburg, , Russia

Site Status RECRUITING

Countries

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Russia

Central Contacts

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Pavel A Kotkov, PhD

Role: CONTACT

+79062619231

Badri V Sigua, MD

Role: CONTACT

+79111979343

Facility Contacts

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Mikhail A Protchenkov, PhD

Role: primary

Badri V Sigua, MD

Role: primary

+79111979343

Aleksei V Osipov, MD

Role: primary

+79219338603

Pavel A Kotkov, PhD

Role: primary

+79062619231

Other Identifiers

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24121989

Identifier Type: -

Identifier Source: org_study_id

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