Ileostomy; ComplicationsNCT05985499
A Randomized Parallel-controlled Study Comparing the Ileostomy "Dumpling Suture Method" With Traditional Suture Method in Rectal Anterior Resection Surgery With Specimen Extraction Via Stoma
A study testing Suturing of ileostomy using "Dumpling suture method" and Suturing of ileostomy using Traditional suture method in people with Ileostomy; Complications, run by Xinhua Hospital, Shanghai Jiao Tong University School of Medicine at 1 site in China.
Trial summary
Natural Orifice Specimen Extraction Surgery (NOSES), which involves obtaining specimens from the abdominal cavity without any incisions, has attracted much attention in recent years, and it has been widely popularized in the treatment of rectal cancer because of its postoperative non-incision, advantages of less… Read more about this study
- Who is it for?
- Ages 18 to 100 years
- Conditions the study is for
- Ileostomy; Complications
- What is being tested?
- Suturing of ileostomy using "Dumpling suture method" and Suturing of ileostomy using Traditional suture method
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 72 participants
- Where
- 1 siteChina
- Study dates
- 21 Mar 2023to 31 Dec 2024
- 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 100 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients scheduled for rectal anterior resection surgery with specimen extraction via stoma
- No serious systemic infection or immunosuppression
- Patients aged above 18 years and below 100 years
- Eastern Cooperative Oncology Group Performance Status: 0-1
- Expected survival time > 6 months
- Patient participate voluntarily and sign an informed consent form
Who cannot join
- Patients who do not require a prophylactic stoma after preoperative evaluation
- Any skin infectious disease of the abdominal wall
- Surgery less than 1 month from the last chemotherapy
- Previously underwent any other stoma surgery
- Presence of a serious active or uncontrollable infection requiring systemic therapy
- Previous history of definite neurological or psychiatric disorders
- Patient may not be able to complete the study for other reasons, or who the investigator believes should not be included
Trial locations and contacts
1 site in 1 country.
China1 site
Xinhua Hospital, Shanghai Jiaotong University School of Medicine
Shanghai, Shanghai Municipality, 200092
About this study
Official title: A Randomized Parallel-controlled Study Comparing the Ileostomy "Dumpling Suture Method" With Traditional Suture Method in Rectal Anterior Resection Surgery With Specimen Extraction Via Stoma (NOSES With Specimen Extraction Via Stoma)
Natural Orifice Specimen Extraction Surgery (NOSES), which involves obtaining specimens from the abdominal cavity without any incisions, has attracted much attention in recent years, and it has been widely popularized in the treatment of rectal cancer because of its postoperative non-incision, advantages of less trauma, quicker recovery, and postoperative aesthetics. Anastomotic fistula is a serious complication of rectal cancer surgery. For patients at high risk of anastomotic fistula, prophylactic ileostomy is often performed intraoperatively to divert feces and protect the anastomosis. For such patients, rectal anterior resection surgery with specimen extraction via stoma (NOSES with specimen extraction via stoma) is usually performed, borrowing a prophylactic stoma incision to retrieve the specimen, and also realizing the absence of additional abdominal incision. However, this procedure is prone to stoma infection and has a high complication rate (20-40%), which limits the popularization of NOSES surgery and is an urgent clinical problem. Our center has proposed a new stoma closure method (Dumpling Suture Method), which reduces the size of the incision by folding the suture to achieve the effect of hiding the skin incision and reduce stoma infection. In our previous study, 17 cases of the new procedure were completed in our center, and 25 patients with stoma closure by the traditional method were included in the same period for control purposes. After six months of follow-up, we found that the "dumpling suture method" significantly reduced the incidence of stoma complications compared with the traditional suture method (5.8% vs. 36%), and no additional adverse effects were observed. This is a single-center, open-label, randomized, parallel-controlled clinical study. The primary endpoint is stoma complication rate within 30 days postoperatively. In this study, we aim to evaluate the efficacy and safety of the "dumpling suture method " compared with the traditional stoma suture in reducing postoperative stoma complications through a randomized parallel controlled clinical trial, which is of great significance for the improvement of the rectal NOSES procedure and the reduction of the incidence of stoma complications.
- Conditions
- Ileostomy; Complications
- Being tested
- Suturing of ileostomy using "Dumpling suture method", Suturing of ileostomy using Traditional suture method
- Keywords
- ileostomy, complications, NOSES, stoma suture
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Suturing of ileostomy using "Dumpling suture method"Procedure or surgery
Suturing of ileostomy using "Dumpling suture method"
Suturing of ileostomy using Traditional suture methodProcedure or surgery
Suturing of ileostomy using Traditional suture method
| Study group | Role | What they receive |
|---|---|---|
| "Dumpling suture" for ileostomy | Experimental | The stoma is fixed with sutures in a skin fold method, and the incision is progressively reduced in a process similar to the process of folding and pinching the Chinese small dumplings. This procedure may reduce stoma complications by progressively reducing the incision and realizing the effect of hiding the skin incision. Receives: Procedure: Suturing of ileostomy using "Dumpling suture method" |
| Traditional suture for ileostomy | Other | The stoma was fixed at the skin using traditional sutures. The incision is narrowed by 2-3 interrupted sutures at the distal and proximal ends of the skin incision on the abdominal wall. The stoma is then fixed at the right lower abdominal incision with sutures. Receives: Procedure: Suturing of ileostomy using Traditional suture method |
What is being measured
The primary outcome is the main question the study is designed to answer.
Complication rate of stoma
Observe and assess for stoma complications
Measured: Within one month after surgery
Secondary outcomes (3)
Stoma DET（Discoloration，Erosion and Tissue overgrowth） score
Measure the state of the skin around the stoma and the corresponding lesion area, ranging from 0-15, higher scores mean a worse outcome of stoma
Measured: Within one month after surgery
Stoma Pain Score
Measurement of stoma pain level using numerical rating scale，ranging from 0-10, higher scores mean a worse outcome of pain
Measured: Within one month after surgery
Quality of life scale score for patients with stoma
Measurement of quality of life for patients with stoma using City of Hope Quality of Life-Ostomy Questionnaire (CHO-QOL-OQ), ranging from 0-3200, higher scores mean a worse outcome of quality of life
Measured: Day 30 after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Aug 2023
- Study start21 Mar 2023
- Primary completion6 Oct 2024
- Study completion31 Dec 2024
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; ComplicationsStudies of the same condition, open and under way.
- 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 72 participants (actual)
Sponsor and investigators
- Lead sponsor
- Xinhua Hospital, Shanghai Jiao Tong University School of Medicine
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Tingyu Wu, Xinhua Hospital, Shanghai Jiao Tong University School of Medicine
- Investigators
- Tingyu Wu, Doctor, Principal investigator, Xinhua Hospital, Shanghai Jiao Tong University School of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05985499
- Sponsor's protocol ID
- XHEC-C-2023-022-2
- Status last verified
- Apr 2024
- First submitted
- 3 Aug 2023
- Last updated
- 30 Apr 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: In this study personal information and data such as patient history, physical examination results, surgical records, and study questionnaire data will be collected. These data will be used to evaluate the efficacy and safety of the new procedure and for academic publication. The researcher will treat the patients' personal data confidentially and anonymize the data and information in any public release of the results of the study.
Publications
Liang Z, Gu J, Liu Y, Zhao Y, Ding W, Wang Z, Du P, Wu T. Dumpling Suture Method Versus Traditional Suture Method of Diverting Loop Ileostomy in Laparoscopic Anterior Rectal Resection With Specimen Extraction Through Stoma Incision: A Randomized, Parallel-Controlled Trial. Dis Colon Rectum. 2026 Mar 1;69(3):420-431. doi: 10.1097/DCR.0000000000004056. Epub 2025 Nov 21.
PubMed 41269064
Study at a glance
From the registry record, last updated by the sponsor on 30 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Parallel-controlled Study Comparing the Ileostomy "Dumpling Suture Method" With Traditional Suture Method in Rectal Anterior Resection Surgery With Specimen Extraction Via Stoma (NOSES With Specimen Extraction Via Stoma)
- ClinicalTrials.gov ID
- NCT05985499
- Acronym / sponsor ID
- XHEC-C-2023-022-2
- Conditions
- Ileostomy; Complications
- Keywords
- ileostomy, complications, NOSES, stoma suture
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 72 participants (actual)
- Lead sponsor
- Xinhua Hospital, Shanghai Jiao Tong University School of MedicineUniversity, hospital or other
- Study start
- 21 Mar 2023 (actual)
- Primary completion
- 6 Oct 2024 (actual)
- Study completion
- 31 Dec 2024 (actual)
- First posted
- 14 Aug 2023 (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.
Natural Orifice Specimen Extraction Surgery (NOSES), which involves obtaining specimens from the abdominal cavity without any incisions, has attracted much attention in recent years, and it has been widely popularized in the treatment of rectal cancer because of its postoperative non-incision, advantages of less trauma, quicker recovery, and postoperative aesthetics. Anastomotic fistula is a serious complication of rectal cancer surgery. For patients at high risk of anastomotic fistula, prophylactic ileostomy is often performed intraoperatively to divert feces and protect the anastomosis. For such patients, rectal anterior resection surgery with specimen extraction via stoma (NOSES with specimen extraction via stoma) is usually performed, borrowing a prophylactic stoma incision to retrieve the specimen, and also realizing the absence of additional abdominal incision. However, this procedure is prone to stoma infection and has a high complication rate (20-40%), which limits the popularization of NOSES surgery and is an urgent clinical problem. Our center has proposed a new stoma closure method (Dumpling Suture Method), which reduces the size of the incision by folding the suture to achieve the effect of hiding the skin incision and reduce stoma infection. In our previous study, 17 cases of the new procedure were completed in our center, and 25 patients with stoma closure by the traditional method were included in the same period for control purposes. After six months of follow-up, we found that the "dumpling suture method" significantly reduced the incidence of stoma complications compared with the traditional suture method (5.8% vs. 36%), and no additional adverse effects were observed. This is a single-center, open-label, randomized, parallel-controlled clinical study. The primary endpoint is stoma complication rate within 30 days postoperatively. In this study, we aim to evaluate the efficacy and safety of the "dumpling suture method " compared with the traditional stoma suture in reducing postoperative stoma complications through a randomized parallel controlled clinical trial, which is of great significance for the improvement of the rectal NOSES procedure and the reduction of the incidence of stoma complications.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| "Dumpling suture" for ileostomy | Experimental | Procedure: Suturing of ileostomy using "Dumpling suture method"The stoma is fixed with sutures in a skin fold method, and the incision is progressively reduced in a process similar to the process of folding and pinching the Chinese small dumplings. This procedure may reduce stoma complications by progressively reducing the incision and realizing the effect of hiding the skin incision. |
| Traditional suture for ileostomy | Other | Procedure: Suturing of ileostomy using Traditional suture methodThe stoma was fixed at the skin using traditional sutures. The incision is narrowed by 2-3 interrupted sutures at the distal and proximal ends of the skin incision on the abdominal wall. The stoma is then fixed at the right lower abdominal incision with sutures. |
Who may qualify
- Ages
- 18 to 100 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Patients scheduled for rectal anterior resection surgery with specimen extraction via stoma
- No serious systemic infection or immunosuppression
- Patients aged above 18 years and below 100 years
- Eastern Cooperative Oncology Group Performance Status: 0-1
- Expected survival time > 6 months
Key exclusion criteria (7 listed)
- Patients who do not require a prophylactic stoma after preoperative evaluation
- Any skin infectious disease of the abdominal wall
- Surgery less than 1 month from the last chemotherapy
- Previously underwent any other stoma surgery
- Presence of a serious active or uncontrollable infection requiring systemic therapy
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 |
|---|---|---|
| Suturing of ileostomy using "Dumpling suture method"Suturing of ileostomy using "Dumpling suture method" | Procedure or surgery | "Dumpling suture" for ileostomy |
| Suturing of ileostomy using Traditional suture methodSuturing of ileostomy using Traditional suture method | Procedure or surgery | Traditional suture for ileostomy |
Primary outcome
Complication rate of stoma
Time frame: Within one month after surgery
Observe and assess for stoma complications
3 secondary outcomes
Stoma DET（Discoloration，Erosion and Tissue overgrowth） score
Time frame: Within one month after surgery
Stoma Pain Score
Time frame: Within one month after surgery
Quality of life scale score for patients with stoma
Time frame: Day 30 after surgery
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Apr 2025.
- Derived from this study: PubMed 41269064Liang Z, Gu J, Liu Y, Zhao Y, Ding W, Wang Z, Du P, Wu T. Dumpling Suture Method Versus Traditional Suture Method of Diverting Loop Ileostomy in Laparoscopic Anterior Rectal Resection With Specimen Extraction Through Stoma Incision: A Randomized, Parallel-Controlled Trial. Dis Colon Rectum. 2026 Mar 1;69(3):420-431. doi: 10.1097/DCR.0000000000004056. Epub 2025 Nov 21.
- Individual participant dataSharing planned: Yes. In this study personal information and data such as patient history, physical examination results, surgical records, and study questionnaire data will be collected. These data will be used to evaluate the efficacy and safety of the new procedure and for academic publication. The researcher will treat the patients' personal data confidentially and anonymize the data and information in any public release of the results of the study.
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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.
Tingyu Wu, Doctor principal investigator
Xinhua Hospital, Shanghai Jiao Tong University School of Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Suturing of ileostomy using "Dumpling suture method" and Suturing of ileostomy using Traditional suture method in people with Ileostomy; Complications, run by Xinhua Hospital, Shanghai Jiao Tong University School of Medicine 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 6 inclusion and 7 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: finished, as of the sponsor's last update on 30 Apr 2025. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Complication rate of stoma (time frame: Within one month after 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 NCT05985499, 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 30 Apr 2025.