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

Ileostomy; Complications Clinical Trial

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)

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05985499
• Other study ID #: XHEC-C-2023-022-2
• Status: Recruiting
• Phase: N/A
• Start date: March 21, 2023
• Est. completion date: December 31, 2024

Study information

• Verified date: April 2024
• Source: Xinhua Hospital, Shanghai Jiao Tong University School of Medicine
• Contact: Min Shi
• Phone: +86-21-25076143
• Email: xinhuahospitalec[@]163.com
• Is FDA regulated: No
• Study type: Interventional

Clinical 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 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 66
• Est. completion date: December 31, 2024
• Est. primary completion date: December 31, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 100 Years

Eligibility

Inclusion Criteria:

1. Patients scheduled for rectal anterior resection surgery with specimen extraction via stoma

2. No serious systemic infection or immunosuppression

3. Patients aged above 18 years and below 100 years

4. Eastern Cooperative Oncology Group Performance Status: 0-1

5. Expected survival time > 6 months

6. Patient participate voluntarily and sign an informed consent form

Exclusion Criteria:

1. Patients who do not require a prophylactic stoma after preoperative evaluation

2. Any skin infectious disease of the abdominal wall

3. Surgery less than 1 month from the last chemotherapy

4. Previously underwent any other stoma surgery

5. Presence of a serious active or uncontrollable infection requiring systemic therapy

6. Previous history of definite neurological or psychiatric disorders

7. Patient may not be able to complete the study for other reasons, or who the investigator believes should not be included

Related Conditions & MeSH terms

• Ileostomy; Complications

Intervention

Procedure:
• Suturing of ileostomy using "Dumpling suture method"
Suturing of ileostomy using "Dumpling suture method"
• Suturing of ileostomy using Traditional suture method
Suturing of ileostomy using Traditional suture method

Locations

Country	Name	City	State
China	Xinhua Hospital, Shanghai Jiaotong University School of Medicine	Shanghai	Shanghai

Sponsors (1)

Lead Sponsor	Collaborator
Xinhua Hospital, Shanghai Jiao Tong University School of Medicine

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Complication rate of stoma	Observe and assess for stoma complications	Day 30 after surgery
Secondary	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
Secondary	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
Secondary	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