Ileostomy - StomaNCT06344923
Peritoneum and Anterior Rectus Sheath Suturing and Ileostomy
A study testing Ileostomy with a support rod instead of the layer of peritoneum and anterior rectus sheath suturing and Ileostomy with the layer of the peritoneum and anterior rectus sheath suturing in people with Ileostomy - Stoma and Rectal Neoplasms, run by Qilu Hospital of Shandong University at 1 site in China.
Trial summary
In the era of laparoscopy, ileostomy via specimen extraction site has been proposed as a novel approach for temporary ostomy creation to prevent anastomotic leak after laparoscopic low anterior rectal resection. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Ileostomy - Stoma, Rectal Neoplasms
- What is being tested?
- Ileostomy with a support rod instead of the layer of peritoneum and anterior rectus sheath suturing and Ileostomy with the layer of the peritoneum and anterior rectus sheath suturing
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 1 siteChina
- Study dates
- 14 May 2024to 1 Sep 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- preventive ileostomy in laparoscopic rectal surgery
Who cannot join
- ileostomy due to anastomotic leak
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Qilu Hospital of Shandong University
Jinan, Shandong, 250012
Xiang Zhang, +8618560089182, xiang.zhang02@hotmail.com
Xiang Zhang, M.D. Ph.D
About this study
Official title: Does Suturing the Peritoneum and Anterior Rectus Sheath Affect the Safety of Temporary Loop Ileostomy After Laparoscopic Anterior Rectal Resection
In the era of laparoscopy, ileostomy via specimen extraction site has been proposed as a novel approach for temporary ostomy creation to prevent anastomotic leak after laparoscopic low anterior rectal resection. Whether suturing the layer of the peritoneum and anterior rectus sheath affects the safety of this novel approach has not been investigated.
- Conditions
- Ileostomy - Stoma, Rectal Neoplasms
- Being tested
- Ileostomy with a support rod instead of the layer of peritoneum and anterior rectus sheath suturing, Ileostomy with the layer of the peritoneum and anterior rectus sheath suturing
- Medical subject headings
- Rectal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ileostomy with a support rod instead of the layer of peritoneum and anterior rectus sheath suturingProcedure or surgery
The terminal ileum about 30cm proximal to the cecum was recognized and was lifted out of the body through the auxiliary incision at the right lower abdomen and made sure that the ileum was not twisted. Appropriate sutures can be used to narrow the peritoneal incision, preferably by inserting one finger. A support rod, made of a 24# silicone drainage tube with a 1ml syringe was passed through the mesentery of the small intestine. The support rod was removed two weeks after surgery. It is appropriate that the ileum wall protruded from the epidermis by about 3cm. After suturing trocar sites, the loop ileostomy was opened along the longitudinal axis of the intestinal wall, and 4-0 absorbable suture was used to fix the stoma and subcutaneous tissue circumferentially with 16-20 stitches.
Ileostomy with the layer of the peritoneum and anterior rectus sheath suturingProcedure or surgery
The terminal ileum about 30cm proximal to the cecum was recognized and was lifted out of the body through the auxiliary incision at the right lower abdomen and made sure that the ileum was not twisted. Appropriate sutures can be used to narrow the peritoneal incision, preferably by inserting one finger. The seromuscular layer of the ileum or the mesentery was intermittently sutured with peritoneum and the anterior sheath of the rectus abdominis circumferentially with 8-10 stitches (3-0 silk thread). It is appropriate that the ileum wall protruded from the epidermis by about 3cm. After suturing trocar sites, the loop ileostomy was opened along the longitudinal axis of the intestinal wall, and 4-0 absorbable suture was used to fix the stoma and subcutaneous tissue circumferentially with 16-20 stitches
| Study group | Role | What they receive |
|---|---|---|
| modified preventive ileostomy | Experimental | Ileostomy with a support rod instead of the layer of peritoneum and anterior rectus sheath suturing Receives: Procedure: Ileostomy with a support rod instead of the layer of peritoneum and anterior rectus sheath suturing |
| conventional preventive ileostomy | Active comparator | Ileostomy with the layer of the peritoneum and anterior rectus sheath suturing Receives: Procedure: Ileostomy with the layer of the peritoneum and anterior rectus sheath suturing |
What is being measured
The primary outcome is the main question the study is designed to answer.
postoperative complications related to ileostomy
Measured: after primary surgery to ileostomy closure (6 months after primary surgery)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Apr 2024
- Study start14 May 2024
- Primary completion31 May 2025 (estimated)
- Study completion1 Sep 2025 (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 Ileostomy - StomaStudies of the same condition, open and under way.
- More trials run by Qilu Hospital of Shandong 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Qilu Hospital of Shandong University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06344923
- Sponsor's protocol ID
- KYLL
- Status last verified
- Mar 2024
- First submitted
- 24 Mar 2024
- Last updated
- 16 Oct 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Mao J, Xia P, Wang Y, An X, Dai Y, Zhang X. Parastomal hernia outcomes after sutured versus unsutured composite techniques for specimen-extraction-site loop ileostomy following laparoscopic low anterior resection: the UNSEAL randomized controlled trial. Surg Endosc. 2026 Sep 25. doi: 10.1007/s00464-026-13420-1. Online ahead of print.
PubMed 42791407
Study at a glance
From the registry record, last updated by the sponsor on 16 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Does Suturing the Peritoneum and Anterior Rectus Sheath Affect the Safety of Temporary Loop Ileostomy After Laparoscopic Anterior Rectal Resection
- ClinicalTrials.gov ID
- NCT06344923
- Acronym / sponsor ID
- KYLL
- Conditions
- Ileostomy - Stoma, Rectal Neoplasms
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- Qilu Hospital of Shandong UniversityUniversity, hospital or other
- Study start
- 14 May 2024 (actual)
- Primary completion
- 31 May 2025 (estimated)
- Study completion
- 1 Sep 2025 (estimated)
- First posted
- 3 Apr 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.
In the era of laparoscopy, ileostomy via specimen extraction site has been proposed as a novel approach for temporary ostomy creation to prevent anastomotic leak after laparoscopic low anterior rectal resection. Whether suturing the layer of the peritoneum and anterior rectus sheath affects the safety of this novel approach has not been investigated.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| modified preventive ileostomy | Experimental | Procedure: Ileostomy with a support rod instead of the layer of peritoneum and anterior rectus sheath suturingIleostomy with a support rod instead of the layer of peritoneum and anterior rectus sheath suturing |
| conventional preventive ileostomy | Active comparator | Procedure: Ileostomy with the layer of the peritoneum and anterior rectus sheath suturingIleostomy with the layer of the peritoneum and anterior rectus sheath suturing |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- preventive ileostomy in laparoscopic rectal surgery
Key exclusion criteria (1 listed)
- ileostomy due to anastomotic leak
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Ileostomy with a support rod instead of the layer of peritoneum and anterior rectus sheath suturingThe terminal ileum about 30cm proximal to the cecum was recognized and was lifted out of the body through the auxiliary incision at the right lower abdomen and made sure that the ileum was not twisted. Appropriate sutures can be used to narrow the peritoneal incision, preferably by inserting one finger. A support rod, made of a 24# silicone drainage tube with a 1ml syringe was passed through the mesentery of the small intestine. The support rod was removed two weeks after surgery. It is appropriate that the ileum wall protruded from the epidermis by about 3cm. After suturing trocar sites, the loop ileostomy was opened along the longitudinal axis of the intestinal wall, and 4-0 absorbable suture was used to fix the stoma and subcutaneous tissue circumferentially with 16-20 stitches. | Procedure or surgery | modified preventive ileostomy |
| Ileostomy with the layer of the peritoneum and anterior rectus sheath suturingThe terminal ileum about 30cm proximal to the cecum was recognized and was lifted out of the body through the auxiliary incision at the right lower abdomen and made sure that the ileum was not twisted. Appropriate sutures can be used to narrow the peritoneal incision, preferably by inserting one finger. The seromuscular layer of the ileum or the mesentery was intermittently sutured with peritoneum and the anterior sheath of the rectus abdominis circumferentially with 8-10 stitches (3-0 silk thread). It is appropriate that the ileum wall protruded from the epidermis by about 3cm. After suturing trocar sites, the loop ileostomy was opened along the longitudinal axis of the intestinal wall, and 4-0 absorbable suture was used to fix the stoma and subcutaneous tissue circumferentially with 16-20 stitches | Procedure or surgery | conventional preventive ileostomy |
Primary outcome
postoperative complications related to ileostomy
Time frame: after primary surgery to ileostomy closure (6 months after primary surgery)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Oct 2024.
- Derived from this study: PubMed 42791407Mao J, Xia P, Wang Y, An X, Dai Y, Zhang X. Parastomal hernia outcomes after sutured versus unsutured composite techniques for specimen-extraction-site loop ileostomy following laparoscopic low anterior resection: the UNSEAL randomized controlled trial. Surg Endosc. 2026 Sep 25. doi: 10.1007/s00464-026-13420-1. Online ahead of print.
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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. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Ileostomy with a support rod instead of the layer of peritoneum and anterior rectus sheath suturing and Ileostomy with the layer of the peritoneum and anterior rectus sheath suturing in people with Ileostomy - Stoma and Rectal Neoplasms, run by Qilu Hospital of Shandong University at 1 site in China.
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 1 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: status not confirmed, as of the sponsor's last update on 16 Oct 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 China. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
postoperative complications related to ileostomy (time frame: after primary surgery to ileostomy closure (6 months after primary surgery)). 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 NCT06344923, 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 16 Oct 2024.