Comparison of Early Operative Treatment and 48 h Conservative Treatment in Small Bowel Obstruction

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

200 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-10-11

Study Completion Date

2024-12-31

Brief Summary

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

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Detailed Description

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At the admission patients undergo abdomen x-ray, general and biochemical blood test and computer tomography (CT). After exclusion of indications for an emergency operation, patients are given a water-soluble contrast. Conservative treatment is carring out to 12 hours from admission. All patients with resolution of small bowel obstruction in 12 hours will be excluded from the research. Criteria for obstruction release of conservative treatment 1. No pain 2. Appearance of gas in the colon 3. Decrease of bloating 4. Contrast in the colon. After that, if obstruction is not resolved, randomization is performed. First group undergo surgery. Second group undergo conservative treatment with water-soluble contrast evaluation until 48 hours. In the second group surgery is performed if the conservative treatment is not effective. The results of early and late surgery and the results of conservative treatment in groups will be compared.

Conditions

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Small Bowel Obstruction Small Bowel Adhesion Strangulation of Ileum

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Early surgery

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.

Group Type ACTIVE_COMPARATOR

Adhesiolysis

Intervention Type PROCEDURE

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.

X-ray diagnostics

Intervention Type RADIATION

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

Computer tomography

Intervention Type RADIATION

Computer tomography of abdomen with iv contrast

Ultrasound

Intervention Type PROCEDURE

Ultrasound of the abdomen (2 times)

General and biochemical blood test

Intervention Type OTHER

General blood test and biochemical blood test 2 times a day

Late surgery

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.

Group Type ACTIVE_COMPARATOR

Adhesiolysis

Intervention Type PROCEDURE

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.

X-ray diagnostics

Intervention Type RADIATION

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

Computer tomography

Intervention Type RADIATION

Computer tomography of abdomen with iv contrast

Ultrasound

Intervention Type PROCEDURE

Ultrasound of the abdomen (2 times)

General and biochemical blood test

Intervention Type OTHER

General blood test and biochemical blood test 2 times a day

Interventions

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Adhesiolysis

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.

Intervention Type PROCEDURE

X-ray diagnostics

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

Intervention Type RADIATION

Computer tomography

Computer tomography of abdomen with iv contrast

Intervention Type RADIATION

Ultrasound

Ultrasound of the abdomen (2 times)

Intervention Type PROCEDURE

General and biochemical blood test

General blood test and biochemical blood test 2 times a day

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

Patients with adhesive small bowel obstruction

Exclusion Criteria

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

Minimum Eligible Age

17 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No