NCT03684902

Brief Summary

The study was conducted in 250 patients who underwent midline Laparotomy at Kasr Al-Ainy emergency department, Cairo University from August 2017 until March 2018. Factors such as age ,sex, body mass index, substance abuse, previous laparotomy, malignancy, diabetes mellitus , ascites, albumin, renal functions, bilirubin, hemoglobin, intra-abdominal pathology, suture material, creation of stoma, post-operative chest infection, , post-operative paralytic ileus, leakage and wound infection were observed and analyzed with odds ratio and P value

Trial Health

87
On Track

Trial Health Score

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

Enrollment
250

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Aug 2017

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 5, 2017

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 30, 2018

Completed
21 days until next milestone

Study Completion

Last participant's last visit for all outcomes

September 20, 2018

Completed
4 days until next milestone

First Submitted

Initial submission to the registry

September 24, 2018

Completed
2 days until next milestone

First Posted

Study publicly available on registry

September 26, 2018

Completed
Last Updated

September 26, 2018

Status Verified

September 1, 2018

Enrollment Period

1.1 years

First QC Date

September 24, 2018

Last Update Submit

September 24, 2018

Conditions

Outcome Measures

Primary Outcomes (1)

  • wound infection

    redness, hotness, swelling of the wound

    4 weeks after surgery

Study Arms (1)

xpolration

EXPERIMENTAL

women who underwent emergency midline laprotomy

Procedure: emergency midline exploratory laparotomy

Interventions

Once an adequate level of anesthesia has been reached, the initial incision into the skin may be made. A scalpel is first used to cut into the superficial layers of the skin.with the diathermy The incision is then continued through the subcutaneous fat, the abdominal muscles, and finally, the peritoneum. (Morris J ;2017) For all the patients, closure of midline laparotomy wound was en-mass closure done with non-absorbable No. 1 (Polypropylene) or slowly absorbable (PDS) (double loop). sutures in continuous single layer fashion with 1 cm interval. (Morris J ;2017) The operative details were recorded with special consideration to the operative diagnosis, presence and types of adhesions, duration of surgery, the need for diversion and stoma formation, the use of intraperitoneal drain and the suture material to close the rectus sheath.

Also known as: midline exploratory laparotomy
xpolration

Eligibility Criteria

Age19 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • All participants were subjected to emergency midline exploration.
  • All participants at any age
  • both sexes were included

You may not qualify if:

  • those who arrested on table or at the immediate postoperative period

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Kasr Alainy medical school

Cairo, 12111, Egypt

Location

Study Officials

  • Ahmed maged, MD

    Professor

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
SCREENING
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
professor

Study Record Dates

First Submitted

September 24, 2018

First Posted

September 26, 2018

Study Start

August 5, 2017

Primary Completion

August 30, 2018

Study Completion

September 20, 2018

Last Updated

September 26, 2018

Record last verified: 2018-09

Locations