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

NCT05199974 | Completed

• 1 other identifier: soh-med-21-12-08
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

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.

Conditions

Midline Laparotomy

Outcome Measures

Primary Outcomes (1)

• Number of burst abdomen post operative

  Number of burst abdomen postoperative in emergency midline laparotomy

  1 month

Study Arms (2)

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

ACTIVE COMPARATOR

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

Procedure: Midline abdominal closure

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

ACTIVE COMPARATOR

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

Interventions

Midline abdominal closure PROCEDURE

Abdominal Closure in Emergency Midline Laparotomy

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.

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Sohag University: lead

Study Sites (1)

Sohag University Hospital

Sohag, Egypt

Location

Related Publications (3)

• 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.

  PMID: 22061310 BACKGROUND

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

  PMID: 18285735 BACKGROUND

• 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.

  PMID: 11379640 BACKGROUND

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: resident doctor at general surgery department sohag university hospital

Study Record Dates

• First Submitted: December 13, 2021
• First Posted: January 20, 2022
• Study Start: November 1, 2021
• Primary Completion: May 30, 2022
• Study Completion: May 30, 2022
• Last Updated: June 7, 2022

Record last verified: 2022-06

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)