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

Sponsor
Sohag University (Other)
Overall Status
Completed
CT.gov ID
NCT05199974
Collaborator
(none)
50
1
2
6.9
7.2

Study Details

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.

Condition or Disease Intervention/Treatment Phase
  • Procedure: Midline abdominal closure
N/A

Study Design

Study Type:
Interventional
Actual Enrollment :
50 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Prevention
Official Title:
( Comparison Between ) Conventional and Modified Smead Jones Method for Abdominal Mass Closure in Emergency Midline Laparotomy
Actual Study Start Date :
Nov 1, 2021
Actual Primary Completion Date :
May 30, 2022
Actual Study Completion Date :
May 30, 2022

Arms and Interventions

Arm Intervention/Treatment
Active Comparator: Group A: Linea alba was closed with conventional continuous technique .

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

Procedure: Midline abdominal closure
Abdominal Closure in Emergency Midline Laparotomy

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

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

Procedure: Midline abdominal closure
Abdominal Closure in Emergency Midline Laparotomy

Outcome Measures

Primary Outcome Measures

  1. Number of burst abdomen post operative [1 month]

    Number of burst abdomen postoperative in emergency midline laparotomy

Eligibility Criteria

Criteria

Ages Eligible for Study:
N/A and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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.

Contacts and Locations

Locations

Site City State Country Postal Code
1 Sohag University Hospital Sohag Egypt

Sponsors and Collaborators

  • Sohag University

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

Responsible Party:
Adham Kadry Metawee, resident doctor at general surgery department sohag university hospital, Sohag University
ClinicalTrials.gov Identifier:
NCT05199974
Other Study ID Numbers:
  • soh-med-21-12-08
First Posted:
Jan 20, 2022
Last Update Posted:
Jun 7, 2022
Last Verified:
Jun 1, 2022
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of Jun 7, 2022