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

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

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.

Study Overview

• Status: Recruiting
• Conditions: Stoma Malfunction

Detailed Description

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.

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.

• Study Type: Observational
• Enrollment (Estimated): 60

Contacts and Locations

• Study Contact: Name: Amira Sayed Mohammed Sayed, Resident; Phone Number: 01061434567; Email: asmsda1996@gmail.Com
• Study Contact Backup: Name: Gamal Abd el hamid Ahmed, Professor; Phone Number: 01006369722; Email: eed@aun.edu.eg

Study Locations

• Egypt
  • Assiut, Egypt
    • Recruiting
    • Assiut University Hospital
    • Contact: Assiut university Hospitals; Phone Number: +2088241-1906; Email: irbasyut@aun.edu.eg

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No

• 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

Description

Inclusion Criteria:

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

Exclusion Criteria:

1. Patient underwent repair of previous abdominal surgery
2. Patient known to have incisional or ventral abdominal hernia

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
a_wound infection b_post operative ilieus c_oedema of the stoma d_soiling around the stoma e:prolapse f: stenosis g:retraction	Stoma related other complication	6 months

Collaborators and Investigators

• Sponsor: Assiut University

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (Actual): December 1, 2023
• Primary Completion (Estimated): October 1, 2026
• Study Completion (Estimated): December 1, 2026

Study Registration Dates

• First Submitted: July 8, 2024
• First Submitted That Met QC Criteria: July 23, 2024
• First Posted (Actual): July 24, 2024

Study Record Updates

• Last Update Posted (Actual): July 24, 2024
• Last Update Submitted That Met QC Criteria: July 23, 2024
• Last Verified: July 1, 2024

More Information

Terms related to this study

• Other Study ID Numbers: Stoma placement

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No