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

Study Overview
=================
Brief 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 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 planned to recruit 66 patients randomized in a 1:1 ratio to the trial and control groups. The primary endpoint is stoma complication rate at 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.

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)

Conditions
-----------------
Ileostomy; Complications

Intervention / Treatment
-----------------
* Procedure: Suturing of ileostomy using Dumpling suture method
* Procedure: Suturing of ileostomy using Traditional suture method


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: 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 Exclusion Criteria: 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

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 100 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Dumpling suture for ileostomy<br>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. | Procedure: Suturing of ileostomy using Dumpling suture method<br>* Suturing of ileostomy using Dumpling suture method<br>|
| Other: Traditional suture for ileostomy<br>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. | Procedure: Suturing of ileostomy using Traditional suture method<br>* Suturing of ileostomy using Traditional suture method<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Complication rate of stoma | Observe and assess for stoma complications | Day 30 after surgery | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 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 | 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 | Day 30 after surgery | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
NOSES, ileostomy, complications, stoma suture