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
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ClinicalTrials.gov Identifier: NCT05985499 |
Recruitment Status :
Recruiting
First Posted : August 14, 2023
Last Update Posted : April 23, 2024
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Condition or disease | Intervention/treatment | Phase |
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Ileostomy; Complications | Procedure: Suturing of ileostomy using "Dumpling suture method" Procedure: Suturing of ileostomy using Traditional suture method | Not Applicable |
Study Type : | Interventional (Clinical Trial) |
Estimated Enrollment : | 66 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Prevention |
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) |
Actual Study Start Date : | March 21, 2023 |
Estimated Primary Completion Date : | December 31, 2024 |
Estimated Study Completion Date : | December 31, 2024 |
Arm | Intervention/treatment |
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Experimental: "Dumpling suture" for ileostomy
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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Procedure: Suturing of ileostomy using "Dumpling suture method"
Suturing of ileostomy using "Dumpling suture method" |
Traditional suture for ileostomy
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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Procedure: Suturing of ileostomy using Traditional suture method
Suturing of ileostomy using Traditional suture method |
- Complication rate of stoma [ Time Frame: Day 30 after surgery ]Observe and assess for stoma complications
- Stoma DET(Discoloration,Erosion and Tissue overgrowth) score [ Time Frame: Day 30 after surgery ]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
- Stoma Pain Score [ Time Frame: Day 30 after surgery ]Measurement of stoma pain level using numerical rating scale,ranging from 0-10, higher scores mean a worse outcome of pain
- Quality of life scale score for patients with stoma [ Time Frame: Day 30 after surgery ]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
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Ages Eligible for Study: | 18 Years to 100 Years (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
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
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05985499
Contact: Min Shi | +86-21-25076143 | xinhuahospitalec@163.com |
China, Shanghai | |
Xinhua Hospital, Shanghai Jiaotong University School of Medicine | Recruiting |
Shanghai, Shanghai, China, 200092 | |
Contact: Min Shi +86-21-25076143 xinhuahospitalec@163.com |
Principal Investigator: | Tingyu Wu, Doctor | Xinhua Hospital, Shanghai Jiao Tong University School of Medicine |
Responsible Party: | Tingyu Wu, Principal Investigator, Xinhua Hospital, Shanghai Jiao Tong University School of Medicine |
ClinicalTrials.gov Identifier: | NCT05985499 |
Other Study ID Numbers: |
XHEC-C-2023-022-2 |
First Posted: | August 14, 2023 Key Record Dates |
Last Update Posted: | April 23, 2024 |
Last Verified: | April 2024 |
Individual Participant Data (IPD) Sharing Statement: | |
Plan to Share IPD: | Yes |
Plan Description: | 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. |
Supporting Materials: |
Study Protocol Statistical Analysis Plan (SAP) Informed Consent Form (ICF) Clinical Study Report (CSR) |
Studies a U.S. FDA-regulated Drug Product: | No |
Studies a U.S. FDA-regulated Device Product: | No |
ileostomy complications NOSES stoma suture |