Ileostomy; ComplicationsNCT06010043

"Dumpling Suture Method" Versus Traditional Suture Method of Protective Loop Ileostomy in Laparoscopic Anterior Rectal Resection With Specimen Extraction Via Stoma: a Retrospective Comparative Study

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.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

Who is it for?: Ages 18 to 80 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: 52 participants
Where: 1 siteChina
Study dates: 1 Aug 2019to 15 Aug 2023
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

All patients underwent successful laparoscopic anterior rectal resection plus protective loop ileostomy with specimen extraction through stoma incision;
All patients were pathologically diagnosed with rectal carcinoma or ulcerative colitis;
Patients aged 18 - 80 years
ASA (American Society of Anesthesiologists) classification ≤ grade 3.
Patient participate voluntarily and sign an informed consent form

Who cannot join

Patients with distant metastasis;
Patients with colon cancer;
Patients with a history of previous abdominal surgery;
ASA (American Society of Anesthesiologists) classification > grade 3;
Patients who underwent emergency surgery;
Patients who underwent surgery ≤ 3 weeks from the last chemotherapy ;
Patients lost to follow-up.

Trial locations and contacts

1 site in 1 country.

China1 site

Xinhua Hospital, Shanghai Jiao Tong University School of Medicine
Shanghai, Shanghai Municipality, 200092

Other trials in China

About this study

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. The study aimed to introduce the "Dumpling suture method" of protective loop ileostomy in laparoscopic anterior resection and compare this new method with the traditional method. From August 1st 2019 to August 1st 2023, 22 cases of the new procedure were completed in our center, and 30 patients with stoma closure by the traditional method were included in the same period for control purposes. A retrospective analysis was conducted on 52 patients in the study center, and the intraoperative details and postoperative outcomes of the two groups were measured.

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 groups in NCT06010043
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: Day 30 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: Day 30 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: Day 30 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.

1 Aug 201915 Aug 2023

First posted24 Aug 2023
Study start1 Aug 2019
Primary completion1 Aug 2023
Study completion15 Aug 2023

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
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: Non-randomised
Intervention model: Parallel groups
Masking: None (open label)
Enrolment: 52 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT06010043
Sponsor's protocol ID: XHEC-2023-D-146
Status last verified: Aug 2023
First submitted: 21 Aug 2023
Last updated: 25 Aug 2023
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.

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

Not yet recruiting
Suture Choice for Ostomy Creation
Ostomy - Ileostomy or Colostomy, Stoma Complications
Recruiting
Novel Post-Surgical Incision Management to Prevent Ostomy Complications
Ostomy, Enterocutaneous Fistula
Not yet recruiting
Phasix Mesh Underlay During Loop Ileostomy Closure
Incisional Hernia of Anterior Abdominal Wall
Recruiting
Safety and Effectiveness Evaluation of the COLO-BT as an Alternative Treatment to the Ileostomy
Colorectal Surgery, Colorectal Cancer
Active, not recruiting
Autologous Fecal Microbiota Transplantation for Anal Function Recovery After Ileostomy Reversal in Rectal Cancer
Rectal Cancer, Low Anterior Resection Syndrome

All Ileostomy; Complications trials

Study at a glance

From the registry record, last updated by the sponsor on 25 Aug 2023. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: "Dumpling Suture Method" Versus Traditional Suture Method of Protective Loop Ileostomy in Laparoscopic Anterior Rectal Resection With Specimen Extraction Via Stoma: a Retrospective Comparative Study
ClinicalTrials.gov ID: NCT06010043
Acronym / sponsor ID: XHEC-2023-D-146
Conditions: Ileostomy; Complications
Keywords: ileostomy, complications, NOSES, stoma suture
Study type: Interventional
Recruitment status: Completed
Enrolment: 52 participants (actual)
Lead sponsor: Xinhua Hospital, Shanghai Jiao Tong University School of MedicineUniversity, hospital or other
Study start: 1 Aug 2019 (actual)
Primary completion: 1 Aug 2023 (actual)
Study completion: 15 Aug 2023 (actual)
First posted: 24 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.

Study design

Primary purpose: Prevention
Allocation: Non-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 80 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (5 listed)

All patients underwent successful laparoscopic anterior rectal resection plus protective loop ileostomy with specimen extraction through stoma incision;
All patients were pathologically diagnosed with rectal carcinoma or ulcerative colitis;
Patients aged 18 - 80 years
ASA (American Society of Anesthesiologists) classification ≤ grade 3.
Patient participate voluntarily and sign an informed consent form

Key exclusion criteria (7 listed)

Patients with distant metastasis;
Patients with colon cancer;
Patients with a history of previous abdominal surgery;
ASA (American Society of Anesthesiologists) classification > grade 3;
Patients who underwent emergency surgery;

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: Day 30 after surgery
Observe and assess for stoma complications

3 secondary outcomes

Stoma DET（Discoloration，Erosion and Tissue overgrowth） score
Time frame: Day 30 after surgery
Stoma Pain Score
Time frame: Day 30 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 25 Aug 2023.
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.

Related trials for Ileostomy; Complications

Not yet recruiting
Suture Choice for Ostomy Creation
Ostomy - Ileostomy or Colostomy, Stoma Complications
Recruiting
Novel Post-Surgical Incision Management to Prevent Ostomy Complications
Ostomy, Enterocutaneous Fistula
Not yet recruiting
Phasix Mesh Underlay During Loop Ileostomy Closure
Incisional Hernia of Anterior Abdominal Wall
Recruiting
Safety and Effectiveness Evaluation of the COLO-BT as an Alternative Treatment to the Ileostomy
Colorectal Surgery, Colorectal Cancer
Active, not recruiting
Autologous Fecal Microbiota Transplantation for Anal Function Recovery After Ileostomy Reversal in Rectal Cancer
Rectal Cancer, Low Anterior Resection Syndrome

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.

The record lists no contact. Use the official record to reach the sponsor.

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

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 5 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 25 Aug 2023. 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: Day 30 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 NCT06010043.

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 25 Aug 2023.