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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| "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. |
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| 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Suturing of ileostomy using "Dumpling suture method" | Procedure | Suturing of ileostomy using "Dumpling suture method" |
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| Measure | Description | Time Frame |
|---|---|---|
| Complication rate of stoma | Observe and assess for stoma complications | Within one month after surgery |
| Measure | Description | Time Frame |
|---|---|---|
| Stoma DETļ¼Discolorationļ¼Erosion and Tissue overgrowthļ¼ 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 | Within one month after surgery |
| Stoma Pain Score |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Tingyu Wu, Doctor | Xinhua Hospital, Shanghai Jiao Tong University School of Medicine | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Xinhua Hospital, Shanghai Jiaotong University School of Medicine | Shanghai | Shanghai Municipality | 200092 | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 41269064 | Derived | 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. |
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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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| Suturing of ileostomy using Traditional suture method | Procedure | Suturing of ileostomy using Traditional suture method |
|
Measurement of stoma pain level using numerical rating scaleļ¼ranging from 0-10, higher scores mean a worse outcome of pain |
| 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 | Day 30 after surgery |