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Comparison Between Conventional and Modified Smead Jones Method for Mass Closure in Emergency Midline Laparotomy

Primary Purpose

Midline Laparotomy

Status
Completed
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
Midline abdominal closure
Sponsored by
Sohag University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Midline Laparotomy

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Any patient has risk factor for weak scar who underwent emergency laparotomy through midline incision .

Exclusion Criteria:

  • Patients who had previous laparotomy.
  • patients who underwent laparotomy through incisions other than midline incisions.

Sites / Locations

  • Sohag University Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

Group A: Linea alba was closed with conventional continuous technique .

Group B: Linea alba was closed with Modified Smead Jones technique with Far-near near-far technique.

Arm Description

Group A: 25 patients included . Linea alba will be closed with conventional continuous technique .

Group B:25 patients included. Linea alba will be closed with Modified Smead jones technique with Far-near near-far technique.

Outcomes

Primary Outcome Measures

Number of burst abdomen post operative
Number of burst abdomen postoperative in emergency midline laparotomy

Secondary Outcome Measures

Full Information

First Posted
December 13, 2021
Last Updated
June 5, 2022
Sponsor
Sohag University
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1. Study Identification

Unique Protocol Identification Number
NCT05199974
Brief Title
Comparison Between Conventional and Modified Smead Jones Method for Mass Closure in Emergency Midline Laparotomy
Official Title
( Comparison Between ) Conventional and Modified Smead Jones Method for Abdominal Mass Closure in Emergency Midline Laparotomy
Study Type
Interventional

2. Study Status

Record Verification Date
June 2022
Overall Recruitment Status
Completed
Study Start Date
November 1, 2021 (Actual)
Primary Completion Date
May 30, 2022 (Actual)
Study Completion Date
May 30, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Sohag University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
The occurrence of sudden disruption of abdominal wall laparotomy wound is a major disaster and a major psychological trauma to the patient . Acute wound dehiscence is defined as postoperative separation of the abdominal musculoaponeurotic layers within 30 days after operation. Many risk factors were incriminated in causation of burst abdomen including malnutrition, anemia, hypo-proteinemia, pre and post-operative prolonged steroid therapy, peritonitis, malignancy, jaundice, uremia and post-operative abdominal distension or cough. Wound dehiscence may be related to the technique of closure of abdomen and the sutures used. Numerous studies have been conducted evaluating many closure techniques and suture materials. There is a number of studies evaluating various closure techniques and suture materials to prevent wound dehiscence following emergency midline laparotomy. In developing countries such as India, most patients operated as an emergency develop wound dehiscence such as they have prolonged intraperitoneal sepsis and malnutrition. The current opinion for closure of a midline incision is mass closure with non-absorbable or slowly absorbable suture . Tension is distributed evenly along the length of the wound. The standard technique for abdominal closure is 'mass closure' (closing all layers of the abdominal wall, excluding the skin), usually with nonabsorbable sutures, although 'slow-resorbing' sutures such as polydioxanone (PDS) are also widely used . In Smead-Jones method of closure tension between two loops is distributed in such a way that the fascial edges are well approximated. Originally described method was interrupted. Continuous method has advantage of being faster and has less risk of wound dehiscence due to dynamic distribution of increased tension in postoperative period due to see-saw effect. We proposed modification of original Smead-Jones technique by doing it in continuous manner to increase the benefits and found this method to be fast, cost-effective, equally effective in controlling wound infection and better than interrupted technique to prevent wound dehiscence.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Midline Laparotomy

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
50 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Group A: Linea alba was closed with conventional continuous technique .
Arm Type
Active Comparator
Arm Description
Group A: 25 patients included . Linea alba will be closed with conventional continuous technique .
Arm Title
Group B: Linea alba was closed with Modified Smead Jones technique with Far-near near-far technique.
Arm Type
Active Comparator
Arm Description
Group B:25 patients included. Linea alba will be closed with Modified Smead jones technique with Far-near near-far technique.
Intervention Type
Procedure
Intervention Name(s)
Midline abdominal closure
Intervention Description
Abdominal Closure in Emergency Midline Laparotomy
Primary Outcome Measure Information:
Title
Number of burst abdomen post operative
Description
Number of burst abdomen postoperative in emergency midline laparotomy
Time Frame
1 month

10. Eligibility

Sex
All
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Any patient has risk factor for weak scar who underwent emergency laparotomy through midline incision . Exclusion Criteria: Patients who had previous laparotomy. patients who underwent laparotomy through incisions other than midline incisions.
Facility Information:
Facility Name
Sohag University Hospital
City
Sohag
Country
Egypt

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
22061310
Citation
Sajid MS, Parampalli U, Baig MK, McFall MR. A systematic review on the effectiveness of slowly-absorbable versus non-absorbable sutures for abdominal fascial closure following laparotomy. Int J Surg. 2011;9(8):615-25. doi: 10.1016/j.ijsu.2011.09.006. Epub 2011 Oct 30.
Results Reference
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PubMed Identifier
18285735
Citation
Begum B, Zaman R, Ahmed M, Ali S. Burst abdomen-A preventable morbidity. Mymensingh Med J. 2008 Jan;17(1):63-6.
Results Reference
background
PubMed Identifier
11379640
Citation
Rucinski J, Margolis M, Panagopoulos G, Wise L. Closure of the abdominal midline fascia: meta-analysis delineates the optimal technique. Am Surg. 2001 May;67(5):421-6.
Results Reference
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Comparison Between Conventional and Modified Smead Jones Method for Mass Closure in Emergency Midline Laparotomy

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