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

NCT ID: NCT05199974

Last Updated: 2022-06-07

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

50 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-11-01

Study Completion Date

2022-05-30

Brief Summary

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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.

Detailed Description

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Conditions

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Midline Laparotomy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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

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

Group Type ACTIVE_COMPARATOR

Midline abdominal closure

Intervention Type PROCEDURE

Abdominal Closure in Emergency Midline Laparotomy

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.

Group Type ACTIVE_COMPARATOR

Midline abdominal closure

Intervention Type PROCEDURE

Abdominal Closure in Emergency Midline Laparotomy

Interventions

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Midline abdominal closure

Abdominal Closure in Emergency Midline Laparotomy

Intervention Type PROCEDURE

Eligibility Criteria

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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.
Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Sohag University

OTHER

Sponsor Role lead

Responsible Party

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Adham Kadry Metawee

resident doctor at general surgery department sohag university hospital

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Sohag University Hospital

Sohag, , Egypt

Site Status

Countries

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Egypt

References

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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.

Reference Type BACKGROUND
PMID: 22061310 (View on PubMed)

Begum B, Zaman R, Ahmed M, Ali S. Burst abdomen-A preventable morbidity. Mymensingh Med J. 2008 Jan;17(1):63-6.

Reference Type BACKGROUND
PMID: 18285735 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 11379640 (View on PubMed)

Other Identifiers

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soh-med-21-12-08

Identifier Type: -

Identifier Source: org_study_id

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