NCT06446440

Brief Summary

Comparison between the results of laparotomy and laparoscopy in adhesive intestinal obstruction and introduce the use of laparoscopy to the emergency setting in Asyut University Hospital.

Trial Health

77
On Track

Trial Health Score

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

Enrollment
40

participants targeted

Target at P25-P50 for all trials

Timeline
7mo left

Started Dec 2023

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
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 Progress81%
Dec 2023Dec 2026

Study Start

First participant enrolled

December 1, 2023

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

June 1, 2024

Completed
5 days until next milestone

First Posted

Study publicly available on registry

June 6, 2024

Completed
2.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2026

Expected
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2026

Last Updated

June 6, 2024

Status Verified

June 1, 2024

Enrollment Period

2.8 years

First QC Date

June 1, 2024

Last Update Submit

June 1, 2024

Conditions

Adhesions Bowel

Outcome Measures

Primary Outcomes (1)

  • Recurrence rate

    Signs and symptoms of intestinal obstruction

    2 years

Study Arms (2)

Group A

These group will include cases underwent laparoscopic adhesiolysis

Procedure: Laparoscopic adhesiolysis

Group B

These group will include cases underwent open adhesiolysis

Procedure: Open adhesiolysis

Interventions

Laparoscopic adhesiolysisPROCEDURE

Laparoscopic adhesiolysis

Group A
Open adhesiolysisPROCEDURE

Open adhesiolysis

Group B

Eligibility Criteria

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

Any case of intestinal obstruction and failed medical treatment and for surgery either open or laparoscopic adhesiolysis

You may qualify if:

  • any male or female above 18 years has adhesive Intestinal obstruction
  • patient fulfilled the criteria to participate but operated before time of study if adequate data available
  • patient in which conservative management is failed

You may not qualify if:

  • othe casues of intestinal obstruction (other than adhsions)
  • shocked patient
  • cardiovascular diseases
  • coagulopathy
  • liver cirrhosis
  • intracranial diseases

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Assiut University Hospital

Asyut, Egypt

RECRUITING

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
General Surgery department at assiut University hospitals

Study Record Dates

First Submitted

June 1, 2024

First Posted

June 6, 2024

Study Start

December 1, 2023

Primary Completion (Estimated)

October 1, 2026

Study Completion (Estimated)

December 1, 2026

Last Updated

June 6, 2024

Record last verified: 2024-06

Locations

EG(1)