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CompletedNCT04065607Updated Aug 22, 2019

Indications and Outcome of Laparostomy

An observational study in Laparotomy, sponsored by Dow University of Health Sciences. Completed. Open to participants aged 20 Years to 70 Years. Per ClinicalTrials.gov, last updated 2019-08-22.

Sponsored by Dow University of Health Sciences · Observational

Study type
Observational
Model
Case-only
Time perspective
Retrospective
Enrollment
40
Ages
20 Years to 70 Years
Sex
All
01

Study summary

Brief study Introduction/background Laparostomy is defined is a surgical procedure in which abdominal cavity is opened and left opened deliberately because of difficult primary closure or when primary closure is avoided due to severe intraabdominal sepsis, trauma and risk of abdominal compartment syndrome.

Patients and methods Retrospective Proforma based study conducted from 1st May 2014-31st May 2018. All patients admitted through emergency diagnosed clinically with peritonitis, intraabdominal sepsis and abdominal trauma managed with laparotomy and laparostomy were included in the study. On laparotomy primary cause was identified and controlled with damaged control surgery to save the lives and abdomen was left open with temporary abdominal wall cover of urine bag stitched all around either with skin or external oblique aponeurosis temporarily for second relook laparotomy after 24-48 hours. On second relook of abdomen haemostasis secured and abdomen was washed with normal saline, any missed pathology identified and controlled and abdomen was closed in some patient when there was no need to recheck the abdomen while in other patients abdominal content were covered again temporarily with urine bag. All patients were managed by the team of surgery and ICU. Finally abdomen was closed by deep tension suture DTS or direct layered closure of abdominal wall.

Read the detailed description

Detail study Introduction Laparostomy is a surgical procedure in which abdominal cavity is opened and left opened deliberately called open abdomen, an open abdomen is based on the principle of incision and drainage of an abscess and leaving the wound open for free drainage, washouts and multiple dressings1.

Usually abdomen is closed primarily in all abdominal surgeries but some time it is difficult to close the abdomen primarily to avoid intraabdominal hypertension because the risk of abdominal compartment syndrome and to manage severe intraabdominal sepsis2. Trauma required damage control surgery 3, and other complex abdominal pathologies, injuries due to explosive devices4, laparostomy and finally staged abdominal closure or DTS deep tension sutures are used to close the abdomen5. Multiple techniques are used to close the abdomen temporarily after laparotomy to have a second relook laparotomy6. Laparostomy is a complex procedure and it is difficult to identify which is the best technique for temporary abdominal closure, primary fascial closure, mesh, plastic sheet, bagota bag, urine bag, vacuum assisted closure are commonly used methods to cover the abdominal content to prevent the risk of injury evisceration and direct exposure to the atmosphere7.

Our objective is to identify the indications and outcome of laparostomy in emergency laparotomy and prevent the abdominal compartment syndrome, in critically ill patients due to fecal peritonitis, intraabdominal sepsis and trauma.

Patients and methods Retrospective Proforma based study conducted from 1st May 2014-31st May 2018 at Dow International Hospital Ojha Campus Dow University of Health Sciences Karachi Pakistan.

Inclusion Criteria: all critically ill patients admitted through emergency, diagnosed with peritonitis, intraabdominal sepsis and trauma managed with damaged control surgery initially along with laparostomy in which the abdomen was left open with temporary abdominal cover to have a relook laparotomy were included in the study Exclusion Criteria: Patients diagnosed clinically with peritonitis and trauma but managed by primary abdominal wall closure were excluded from the study.

Initially all Patients were optimized and resuscitated and all necessary investigations were send in emergency eg blood grouping and cross matching, blood complete picture, serum electrolyte ,blood urea \& creatinine screening for hepatitis. Antibiotic cover, fluid and electrolyte support was given to all patients. FFP arranged according to the requirement. Imaging performed where necessary in stable patients.

On laparotomy primary cause was identified and managed with damaged control surgery along with abdominal washout and abdomen was covered with a urine bag open from the center to make a sheet then sutured all around with the skin or external oblique aponeurosis. All patients were managed in the ICU initially for a second relook laparotomy.

Second relook laparotomy was performed after 24-48 hours abdomen was washed with normal saline haemostasis secured and any missed primary pathology was identified and controlled. Abdomen was closed in few patient where no need to recheck the abdomen, while in remaining patients abdominal content were covered again with urine bag who require multiple washouts and dressing. All patients managed by the team of ICU, anesthesia, surgeon, and physician from critical care medicine. Morbidity and mortality happen recorded during the period of hospital stay Patient discharged after complete recovery with the final closure of abdominal wall either with deep tension suture DTS figure 4 or direct layered closure of abdominal wall. Data was collected and recorded on a pre designed research Proforma made for this study. SPSS version 20 was used to analyze the data.

02

Conditions studied

  • Laparotomy

Keywords

  • Laparotomy
  • Laparostomy
  • Open abdomen (OA)
  • Temporary abdominal closure (TAC)
  • Relook laparotomy
03

In context

Lead sponsor

Dow University of Health Sciences is the lead sponsor of 176 studies on the registry; 32 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
20 Years to 70 Years
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

ll Emergency surgery and intensive care admission who require exploratory laparotomy

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • Patients admitted through emergency surgery, diagnosed with fecal peritonitis
  • Intraabdominal sepsis due to tuberculosis \& typhoid perforation
  • Trauma managed with damaged control surgery need a relook laparotomy

Exclusion criteria

Exclusion Criteria:

  • Patients diagnosed clinically with peritonitis and traumas, managed by primary abdominal wall closure were excluded from the study.
  • Age below 20 years
  • Age above 70 years
05

Study design

Observational model
Case-only
Time perspective
Retrospective
Enrollment
40 participants (actual)
Patient registry
No

Interventions

  • ProcedureReopen the abdomen to check missed pathology or abdominal washouts

    Re opening of the abdomen once the patient is stabilized after 24-48 hours to check the missed injury after damaged control surgery in trauma and to control the sepsis in fecal peritonitis due to abdominal tuberculosis or typhoid perforation

06

What researchers measure

Primary outcomes

  1. Indications of Laparostomy

    Conditions or disease for which laparostomy performed

    Time frame: Duration of study: 1st May 2014-31st May 2018.

  2. Mortality

    Mortality happen during hospital stay

    Time frame: Two months

Secondary outcomes

  1. Chest infection

    Chest infection during the admission in hospital

    Time frame: Two months

  2. Abdominal wall surgical site infection

    Infection of abdominal wall during hospital admission or after discharge

    Time frame: Four months

07

Study locations

No study locations are listed for this record.

08

References and documents

Individual participant data

Plan to share: Yes — Study can be shared after the publication

Supporting information: Study protocol, Statistical analysis plan, Informed consent form, Clinical study report, Analytic code

Time frame: One month after the publication

Access criteria: pubmed id

No publications or documents are linked to this record.

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reached

Ran from May 2014 to primary completion in May 2018, 48 months.

How these figures are worked out, and which studies are left out of them.

Registered
Aug 10, 2019
First posted
Aug 22, 2019
StartActual
May 1, 2014
Primary completionActual
May 31, 2018
CompletionActual
May 31, 2018
Last update
Aug 22, 2019
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Aug 22, 2019, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT04065607
Responsible party
Shahida Parveen Afridi (Professor and Head of Department of surgery, Dow University of Health Sciences) — Principal investigator
First posted
Aug 22, 2019
Start date
May 1, 2014
Primary completion
May 31, 2018
Completion
May 31, 2018
Last update
Aug 22, 2019

Study contacts

Shahida Afridi, FCPS
principal investigator · HOD of Surgery Dow University Hospital .Dow University of Health Sciences
Naveed Khan, FCPS,MRCS
study chair · Assciate Professor Surgery Dow University of Health Sciences

Oversight

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

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This study is completed, as verified in Aug 2019. You cannot join it, but the record below documents what was studied.

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