Para Versus Trans Rectus Stoma Placement for Prevention of Stoma Related Complications

NCT06517407 | Recruiting

• 1 other identifier: Stoma placement
• Study Type: observational
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

Fecal divertion is a surgical procedure by which stoma is constructed through exteriorization of small intestine or large intestine(loop or end stoma).There are many indications for enterostomies such as malignancy, bleeding per rectum, MVO, Volvulus, iatrogenic colon injury, adhesive bands....... etc. Many factors concerning the operative technique are considered to influence the incidence of stoma related complications such as stoma prolapse, retraction, stenosis, para stomal herniation, para stomal soiling ,oedema and ileus. Site of stoma creation in relation to rectus abdominis muscle is believed to be one of them.

Conditions

Stoma Malfunction

Outcome Measures

Primary Outcomes (1)

• para stomal herniation

  * Stoma site was incised about 3-5cm from lateral edge of rectus abdominis muscle at para rectus position, or * at he lateral edge of the rectus abdominis muscle in trans rectal position.

  6 months

Secondary Outcomes (1)

• a_wound infection b_post operative ilieus c_oedema of the stoma d_soiling around the stoma e:prolapse f: stenosis g:retraction

  6 months

Eligibility Criteria

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

Study Population

Lateral para rectal or trans rectal stoma exteriorization. * Stoma site was incised about 3-5 cm from lateral edge of rectus abdominal muscle at para rectus position, or * at he lateral edge of the rectus abdominal muscle in trans rectal position

You may qualify if:

• All patient who recieve abdominal enterostomies either elective or emergencies in surgery department of assuit university hospital

You may not qualify if:

• Patient underwent repair of previous abdominal surgery
• Patient known to have incisional or ventral abdominal hernia

Sponsors & Collaborators

• Assiut University: lead

Study Sites (1)

Assiut university Hospital

Asyut, Egypt

RECRUITING

Related Publications (1)

• Hardt J, Meerpohl JJ, Metzendorf MI, Kienle P, Post S, Herrle F. Lateral pararectal versus transrectal stoma placement for prevention of parastomal herniation. Cochrane Database Syst Rev. 2019 Apr 24;4(4):CD009487. doi: 10.1002/14651858.CD009487.pub3.

  PMID: 31016723 RESULT

Central Study Contacts

Amira Sayed Mohammed Sayed, Resident

CONTACT

01061434567; asmsda1996@gmail.Com

Gamal Abd el hamid Ahmed, Professor

CONTACT

01006369722; eed@aun.edu.eg

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: General surgery department at assiut university Hospitals

Study Record Dates

• First Submitted: July 8, 2024
• First Posted: July 24, 2024
• Study Start: December 1, 2023
• Primary Completion (Estimated): October 1, 2026
• Study Completion (Estimated): December 1, 2026
• Last Updated: July 24, 2024

Record last verified: 2024-07

Locations

EG (1)