LaparotomyNCT04065607
Indications and Outcome of Laparostomy
An observational study of Laparotomy, run by Dow University of Health Sciences.
Trial 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. Read more about this study
- Who is it for?
- Ages 20 to 70 years
- Conditions the study is for
- Laparotomy
- What is being tested?
- Reopen the abdomen to check missed pathology or abdominal washouts
- Type of treatment
- Surgery or procedure
- How many people
- 40 participants
- Where
- No sites listed yet
- Study dates
- 1 May 2014to 31 May 2018
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: ll Emergency surgery and intensive care admission who require exploratory laparotomy
Who may be able to join
- 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
Who cannot join
- 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
About this study
Official title: Professor and Head of Department of Surgery Dow University Hospital DUHS
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.
- Conditions
- Laparotomy
- Being tested
- Reopen the abdomen to check missed pathology or abdominal washouts
- Keywords
- Laparotomy, Laparostomy, Open abdomen (OA), Temporary abdominal closure (TAC), Relook laparotomy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Reopen the abdomen to check missed pathology or abdominal washoutsProcedure or surgery
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
What is being measured
The primary outcome is the main question the study is designed to answer.
Indications of Laparostomy
Conditions or disease for which laparostomy performed
Measured: Duration of study: 1st May 2014-31st May 2018.
Mortality
Mortality happen during hospital stay
Measured: Two months
Secondary outcomes (2)
Chest infection
Chest infection during the admission in hospital
Measured: Two months
Abdominal wall surgical site infection
Infection of abdominal wall during hospital admission or after discharge
Measured: Four months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Aug 2019
- Study start1 May 2014
- Primary completion31 May 2018
- Study completion31 May 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for LaparotomyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Retrospective
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Dow University of Health Sciences
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Shahida Parveen Afridi, Dow University of Health Sciences
- Investigators
- Shahida Afridi, FCPS, Principal investigator, HOD of Surgery Dow University Hospital .Dow University of Health SciencesNaveed Khan, FCPS,MRCS, Study chair, Assciate Professor Surgery Dow University of Health Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04065607
- Sponsor's protocol ID
- DIMC 233
- Status last verified
- Aug 2019
- First submitted
- 10 Aug 2019
- Last updated
- 22 Aug 2019
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Study can be shared after the publication
Study at a glance
From the registry record, last updated by the sponsor on 22 Aug 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Professor and Head of Department of Surgery Dow University Hospital DUHS
- ClinicalTrials.gov ID
- NCT04065607
- Acronym / sponsor ID
- DIMC 233
- Conditions
- Laparotomy
- Keywords
- Laparotomy, Laparostomy, Open abdomen (OA), Temporary abdominal closure (TAC), Relook laparotomy
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Dow University of Health SciencesUniversity, hospital or other
- Study start
- 1 May 2014 (actual)
- Primary completion
- 31 May 2018 (actual)
- Study completion
- 31 May 2018 (actual)
- First posted
- 22 Aug 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Observational model
- Case only
- Time perspective
- Retrospective
Who may qualify
- Ages
- 20 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- ll Emergency surgery and intensive care admission who require exploratory laparotomy
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Reopen the abdomen to check missed pathology or abdominal washoutsRe 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 | Procedure or surgery | – |
Primary outcome
Indications of Laparostomy
Time frame: Duration of study: 1st May 2014-31st May 2018.
Conditions or disease for which laparostomy performed
Mortality
Time frame: Two months
Mortality happen during hospital stay
2 secondary outcomes
Chest infection
Time frame: Two months
Abdominal wall surgical site infection
Time frame: Four months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Aug 2019.
- Individual participant dataSharing planned: Yes. Study can be shared after the publication
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
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
Questions about this trial
What is this clinical trial studying?
An observational study of Laparotomy, run by Dow University of Health Sciences.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 22 Aug 2019. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Indications of Laparostomy (time frame: Duration of study: 1st May 2014-31st May 2018.). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Aug 2019.