COMPARISON OF CONTINUOUS VERSUS INTERRUPTED-X SUTURING TECHNIQUE FOR CLOSURE OF RECTUS SHEATH IN PATIENTS UNDERGOING EMERGENCY LAPAROTOMY FOR HOLLOW VISCUS PERFORATION
1 other identifier
interventional
86
1 country
1
Brief Summary
THIS STUDY IS GOING TO COMPARE THE INCIDENCE OF BURST ABDOMEN IN PATIENTS UNDERGOING LAPAROTOMY WOUND CLOSURE IN CONTINUOUS VERSUS INTERRRUPTED-X MANNER
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Jun 2022
1 active site
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 Start
First participant enrolled
June 2, 2022
CompletedFirst Submitted
Initial submission to the registry
November 20, 2022
CompletedFirst Posted
Study publicly available on registry
November 30, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 1, 2023
CompletedStudy Completion
Last participant's last visit for all outcomes
November 3, 2023
CompletedNovember 30, 2022
November 1, 2022
9 months
November 20, 2022
November 20, 2022
Conditions
Outcome Measures
Primary Outcomes (1)
Burst abdomen
It is defined as partial or complete separation of the abdominal musculo-aponeurotic layer leading to protrusion or evisceration of abdominal contents.
1-14 days
Secondary Outcomes (3)
Pain score
1-14 days
Superficial surgical site infection
1-14 days
Deep surgical site infection
1-14 days
Study Arms (2)
Patients with hollow viscus perforation
ACTIVE COMPARATORPatient with hollow viscus perforation
ACTIVE COMPARATORInterventions
In continuous closure, each bite will be taken 2 cm from the cut edge of linea alba and successive bites taken 1 cm from each other in continuous fashion followed by gentle approximation of the wound
In interrupted X closure, large bite will be taken outside-in, 2 cm from the cut edge of linea alba and the needle emerged on the other side from inside out diagonally 2 cm from the edge and 4 cm below the first bite and this strand will be crossed and continued outside-in, diagonally at 90 degree to the first diagonal. The two ends will be tied just tight enough to approximate the edges of linea alba.
Eligibility Criteria
You may qualify if:
- All patients of both genders with age greater than 18 years, undergoing emergency laparotomy through midline incision for hollow viscus perforation.
- ASA grade III
You may not qualify if:
- Patients who had undergone a previous laparotomy for any condition or had an incisional hernia or burst abdomen at presentation.
- Patients undergoing laparotomy with anterior abdominal wall injury in the form of muscle hematoma, disruption or abdominal wall laceration.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
King Edward Medical University / Mayo Hospital
Lahore, Punjab Province, 54000, Pakistan
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
November 20, 2022
First Posted
November 30, 2022
Study Start
June 2, 2022
Primary Completion
March 1, 2023
Study Completion
November 3, 2023
Last Updated
November 30, 2022
Record last verified: 2022-11