Indications and Outcome of Laparostomy

NCT04065607 | Completed DMC

• 1 other identifier: DIMC 233
• Study Type: observational
• Target: 40
• Locations: 0 countries
• Sites: N/A

Brief 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.

Conditions

Laparotomy

Keywords

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

Outcome Measures

Primary Outcomes (2)

• Indications of Laparostomy

  Conditions or disease for which laparostomy performed

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

• Mortality

  Mortality happen during hospital stay

  Two months

Secondary Outcomes (2)

• Chest infection

  Two months

• Abdominal wall surgical site infection

  Four months

Interventions

Reopen the abdomen to check missed pathology or abdominal washouts PROCEDURE

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

Eligibility Criteria

• Age: 20 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

ll Emergency surgery and intensive care admission who require exploratory laparotomy

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Dow University of Health Sciences: lead

Study Officials

• Shahida Afridi, FCPS

  HOD of Surgery Dow University Hospital .Dow University of Health Sciences

  PRINCIPAL INVESTIGATOR

• Naveed Khan, FCPS,MRCS

  Assciate Professor Surgery Dow University of Health Sciences

  STUDY CHAIR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor and Head of Department of surgery

Study Record Dates

• First Submitted: August 10, 2019
• First Posted: August 22, 2019
• Study Start: May 1, 2014
• Primary Completion: May 31, 2018
• Study Completion: May 31, 2018
• Last Updated: August 22, 2019

Record last verified: 2019-08

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE
• Time Frame: One month after the publication
• Access Criteria: pubmed id