CClinicalTrials.gg
RecruitingNCT06175442Updated Dec 18, 2023

Effectiveness of Small Bowel Decompression Techniques in Patients With Small Bowel Obstruction

An observational study in Small Bowel Obstruction, Small Bowel Obstruction Adhesion and Small-Bowel Obstruction Due to Volvulus, sponsored by North-Western State Medical University named after I.I.Mechnikov. Recruiting at 8 sites in Russian Federation. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2023-12-18.

Sponsored by North-Western State Medical University named after I.I.Mechnikov · Observational

Study type
Observational
Model
Cohort
Time perspective
Retrospective
Enrollment
500
Ages
18 Years and older
Sex
All
01

Study summary

This study will compare results of different intestinal decompression techniques in patients with small bowel obstruction.

Read the detailed description

Taking into account the large number of different variations of intestinal decompression methods, a comparative analysis will be carried out based on one comparison group (I) and three main ones (IA-B). The comparison criterion will be a group of patients with nasogastric drainage as the only method of the gastrointestinal tract decompression during surgery and in the postoperative period. In the main groups more active methods of intestinal decompression will be performed, including drainage of the initial parts of the small intestine or total intubation, both single-stage intraoperative and its extended version

02

Conditions studied

  • Small Bowel Obstruction
  • Small Bowel Obstruction Adhesion
  • Small-Bowel Obstruction Due to Volvulus
  • Hernia Incarcerated

Keywords

  • Acute intestinal obstruction, small bowel obstruction, nasointestinal tube, nasogastric tube
03

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Sampling method
Non-probability sample

Study population

Adult patients with benign forms of acute small intestinal obstruction and indications for the small intestine intubation: dilation of the the small intestine lumen above the level of a mechanical obstacle to 3.0 cm in diameter or more or the presence of intestinal paresis with the development of edema and microcirculatory disorders in intestinal wall.

Inclusion criteria

  • acute adhesive intestinal obstruction, including strangulation forms;
  • incarcerated ventral hernias, accompanied by impaired intestinal passage;
  • acute adhesive intestinal obstruction in the hernial sac;
  • obstruction of the small intestine lumen with gallstones and other foreign bodies.

Exclusion criteria

Exclusion Criteria:

  • with peritonitis and other complicated surgical infection;
  • operations with intestinal resection;
  • patients after laparostomy
04

Study design

Observational model
Cohort
Time perspective
Retrospective
Enrollment
500 participants (estimated)
Patient registry
No

Groups and cohorts

  • Nasogastric tube only (I)

    Nasogastric intubation only will be the only method of intestinal decompression both intra- and postoperatively.

    Device: Intraoperative intestinal decompression

  • Short nasointestinal tube (IIA)

    Intraoperative intestinal decompression will be performed by placing the tube behind the ligament of Treitz and expressing the contents in the proximal direction or by total nasointestinal intubation with subsequent intraopertional tube withdrawal. Postoperative decompression will consist of the tube behind the ligament of Treitz.

    Device: Intraoperative intestinal decompression

  • Long nasointestinal tube intraoperative (IIB)

    Total intraoperative intubation of the small intestine followed by replacement with a nasogastric tube.

    Device: Intraoperative intestinal decompression

  • Long nasointestinal tube postoperative (IIC)

    Total intraoperative intubation of the small intestine with a long tube, which will persist in the postoperative period

    Device: Intraoperative intestinal decompression

Interventions

  • DeviceIntraoperative intestinal decompression

    Insertion the tubes of various lengths (nasogastral, short and long nasointestinal) into the gastrointestinal tract during operations in patients with acute small intestinal obstruction

05

What researchers measure

Primary outcomes

  1. 30-day postoperative mortality

    Number of patients, died during 30 days after the operation

    Time frame: 30 days after operation

Secondary outcomes

  1. Postoperative complications

    Postoperative complications, defined according Clavien-Dindo classification

    Time frame: 30 days after operation

06

Study locations

8 of 8 sites recruiting
  • Chelyabinsk regional clinical hospital
    Chelyabinsk, Russian Federation
    • Vladislav A Leschenko · Contact · +79226336699
    Recruiting
  • City Clinical Hospital No. 40
    Ekaterinburg, Russian Federation
    Recruiting
  • City Clinical Hospital №4
    Perm, Russian Federation
    Recruiting
  • North-Western State Medical University named after I. I. Mechnikov
    Saint Petersburg, Russian Federation
    • Badri V Sigua, MD · Contact
    Recruiting
  • Saint-Petersburg I.I. Dzhanelidze Research Institute of Emergency Medicine
    Saint Petersburg, Russian Federation
    Recruiting
  • St Petersburg State Budgetary Institution Of Health Care City Mariinskaya Hospital
    Saint Petersburg, Russian Federation
    Recruiting
  • The City Hospital of the Holy Martyr Elizabeth
    Saint Petersburg, Russian Federation
    • Pavel A Kotkov · Contact · +79062619231
    Recruiting
  • State Healthcare Facility "City Clinical Emergency Hospital No 25"
    Volgograd, Russian Federation
    • Aleksandr S R, Ryzhih · Contact · +79226721179
    Recruiting
07

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

08

Registry details

Key details

Study ID
NCT06175442
Lead sponsor
North-Western State Medical University named after I.I.Mechnikov
Responsible party
Kotkov Pavel (Assistant of the Faculty Surgery Department in NWSMU, North-Western State Medical University named after I.I.Mechnikov) — Principal investigator
First posted
Dec 18, 2023
Start date
Dec 1, 2023
Primary completion
May 31, 2024 (estimated)
Completion
Sep 1, 2024 (estimated)
Last update
Dec 18, 2023

Study contacts

Pavel A Kotkov, PhD
Contact
kotkovdr@mail.ru
+79062619231
Badri V Sigua, MD
Contact
dr.sigua@gmail.com
+79111979343

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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