The Comparison of Interrupted Modified Smead-Jones Versus Conventional Continuous Suturing Technique for Closure of Rectus Sheath in Patients Undergoing Laparotomy for Hollow Viscus Perforation.

NCT06697067 | Recruiting

• 2 other identifiers: 163/RC/Kemu12921/REG/KEMU/24
• Study Type: interventional
• Target: 108
• Locations: 1 country
• Sites: 1

Brief Summary

After taking approval from Board of Studies, IRB \& ASRB of KEMU, 108 patients fulfilling inclusion criteria will be admitted in Department of General Surgery, East Surgical Ward, Mayo Hospital Lahore through Emergency Department. Firstly patients will be seen in emergency department, history and clinical examination will be done and laboratory investigations and imaging will be done. All the patients aged greater than 18 years undergoing emergency laparotomy for hollow viscus perforation will be included in the study. Informed consent will be obtained. Demographic data including name, age, sex will be recorded. Emergency laparotomy will be done with midline incision and intra-operative findings will be recorded. Thorough peritoneal lavage will be done and necessary procedures will be carried out for the pathology identified, and abdominal drains will be placed. The patients then will be randomly divided into 2 groups; group A (Experimental Group) undergoing Modified Smead-Jones interrupted suture technique and group B (Reference Group) undergoing conventional continuous suture closure of rectus sheath. In Modified Smead-jones suture technique describe as a far bite starting at 2 cm on the edge of linea from outside-in and then taking a near bite of 0.5 cm on the other side inside-out- a near bite on the same side outside-in and then a far bite on the other side inside-out. The suture was next converted to a horizontal mattress by taking a far bite 1 cm above or below the previous bite on the other side- near bite on the same side, near bite on the other side, and finally a far bite on the same side. The two ends of the suture were tied to approximate the edges of the linea alba9. In conventional continuous closure suture technique I will use number 1 polypropylene suture, care being taken to place each bite 1-1.5 cm from the cut edge of linea alba and successive bites being taken 1cm away from each other The edges of linea alba were gently approximated without strangulation with an attempt to keep a suture to wound length ratio of 4:110.Rectus sheath will be closed by the suture material No.1 polypropylene in both groups. The midline laparotomy wound will be managed with daily antiseptic dressing and intravenous antibiotics. All patients will be examined daily till discharge then weekly till 2 weeks and on each visit, a slandered physical examination of abdomen of wound will be done and presence of burst abdomen will be noted. When there are no signs of burst abdomen (after 14 postoperative days) the laparotomy wound will be considered normal. All the data will be collected in accordance to patient's proforma.

Conditions

Wound Dehiscence, Surgical

Keywords

Farrukh 24

Outcome Measures

Primary Outcomes (1)

• safety

  best closure technique of rectus sheath

  15days after emergent laparotomy

Study Arms (2)

Patient undergoing emergent laparotomy due to hollow viscus perforation

EXPERIMENTAL

Procedure: modified smead jones

patient undergoing emergent laparotomy

EXPERIMENTAL

patient undergoing emergent laparotomy for hollow viscus perforation

Procedure: conventional comtinuous suture techniques

Interventions

modified smead jones PROCEDURE

interrupted suture technique

Patient undergoing emergent laparotomy due to hollow viscus perforation

conventional comtinuous suture techniques PROCEDURE

continuous suture technique

patient undergoing emergent laparotomy

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• ASA grade III -

You may not qualify if:

• Patients undergoing laparotomy with anterior abdominal wall injury in the form of muscle, hematoma, disruption or abdominal wall laceration.

Sponsors & Collaborators

• King Edward Medical University: lead
• Mayo Hospital Lahore: collaborator

Study Sites (1)

Department of Surgery, King Edward Medical University

Lahore, Punjab Province, 54000, Pakistan

RECRUITING

MeSH Terms

Conditions

Surgical Wound Dehiscence

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Randomised control trials

Study Record Dates

• First Submitted: November 17, 2024
• First Posted: November 20, 2024
• Study Start: June 6, 2024
• Primary Completion: June 6, 2025
• Study Completion: June 21, 2025
• Last Updated: November 20, 2024

Record last verified: 2024-11

Locations

PA (1)