Stoma MalfunctionNCT06517407
Para Versus Trans Rectus Stoma Placement for Prevention of Stoma Related Complications
An observational study of Stoma Malfunction, run by Assiut University at 1 site in Egypt.
Trial 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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Stoma Malfunction
- How many people
- 60 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Dec 2023to Dec 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
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
Who may be able to join
- All patient who recieve abdominal enterostomies either elective or emergencies in surgery department of assuit university hospital
Who cannot join
- Patient underwent repair of previous abdominal surgery
- Patient known to have incisional or ventral abdominal hernia
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Egypt1 site, 1 recruiting
- Recruiting
Assiut university Hospital
Asyut
Assiut university Hospitals, +2088241-1906, irbasyut@aun.edu.eg
About this study
Official title: 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.
Read the 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.
- Conditions
- Stoma Malfunction
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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
Stoma related other complication
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jul 2024
- Study start1 Dec 2023
- Primary completionOct 2026 (estimated)
- Study completionDec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Stoma MalfunctionStudies of the same condition, open and under way.
- More trials run by Assiut UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Amira Sayed Mohamed Sayed, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06517407
- Sponsor's protocol ID
- Stoma placement
- Status last verified
- Jul 2024
- First submitted
- 8 Jul 2024
- Last updated
- 24 Jul 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
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.
PubMed 31016723
Study at a glance
From the registry record, last updated by the sponsor on 24 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Para Rectus Versus Trans Rectus Stoma Placement for Prevention of Stoma Related Complications
- ClinicalTrials.gov ID
- NCT06517407
- Acronym / sponsor ID
- Stoma placement
- Conditions
- Stoma Malfunction
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- 1 Dec 2023 (actual)
- Primary completion
- Oct 2026 (estimated)
- Study completion
- Dec 2026 (estimated)
- First posted
- 24 Jul 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Observational model
- Other
- Time perspective
- Prospective
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- 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
Key inclusion criteria (1 listed)
- All patient who recieve abdominal enterostomies either elective or emergencies in surgery department of assuit university hospital
Key exclusion criteria (2 listed)
- Patient underwent repair of previous abdominal surgery
- Patient known to have incisional or ventral abdominal hernia
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
para stomal herniation
Time frame: 6 months
* 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.
1 secondary outcome
a_wound infection b_post operative ilieus c_oedema of the stoma d_soiling around the stoma e:prolapse f: stenosis g:retraction
Time frame: 6 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Jul 2024.
- Results publication: PubMed 31016723Hardt 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.
- Individual participant dataSharing planned: Undecided
Related trials for Stoma Malfunction
Not yet recruiting
Suture Choice for Ostomy Creation
Ostomy - Ileostomy or Colostomy, Stoma Complications
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Stoma Malfunction, run by Assiut University at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 24 Jul 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Amira Sayed Mohammed Sayed, Resident (01061434567, asmsda1996@gmail.Com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
para stomal herniation (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06517407, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Jul 2024.