History of Changes for Study: NCT05627284

A Prospective Clinical Trial of Colostomy-replacement Combined With Bio-mesh Placement in the Prevention of SSIH

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Version	A	B	Submitted Date	Changes
1			November 16, 2022	None (earliest Version on record)

Study Identification


Unique Protocol ID:	2022-LCYJ-PY-33
Brief Title:	A Prospective Clinical Trial of Colostomy-replacement Combined With Bio-mesh Placement in the Prevention of SSIH
Official Title:	A Prospective Clinical Trial of Colostomy-replacement Combined With Bio-mesh Placement in the Prevention of SSIH
Secondary IDs:

Study Status


Record Verification:	October 2022
Overall Status:	Recruiting
Study Start:	October 1, 2022
Primary Completion:	September 30, 2024 [Anticipated]
Study Completion:	September 30, 2025 [Anticipated]

First Submitted:	November 16, 2022
First Submitted that Met QC Criteria:	November 16, 2022
First Posted:	November 25, 2022 [Actual]

Last Update Submitted that Met QC Criteria:	November 16, 2022
Last Update Posted:	November 25, 2022 [Actual]

Sponsor/Collaborators


Sponsor:	The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School
Responsible Party:	Sponsor
Collaborators:

Oversight


U.S. FDA-regulated Drug:	No
U.S. FDA-regulated Device:	No
Data Monitoring:

Study Description

Brief Summary:

The goal of this clinical trial is to explore the safety and effectiveness of stoma reversal combining bio-mesh placement in patients with high risk of stoma site incisional hernia (SSIH). The main questions it aims to answer are:

Whether bio-mesh placement is safe for patients with a high risk of SSIH.
Whether stoma reversal combining bio-mesh placement is a preventive strategy for patients with high risk of SSIH.
Whether stoma reversal combining bio-mesh placement will trigger other complications.

Participants who are eligible and are enrolled in this study will receive stoma reversal combining bio-mesh placement surgery. After that, they will be followed up for one year to evaluate the occurrence of SSIH and other complications.

Detailed Description:

Conditions


Conditions:	Stoma Site Incisional Hernia
Keywords:	Stoma Site Incisional Hernia Colon cancer

Study Design


Study Type:	Interventional
Primary Purpose:	Prevention
Study Phase:	Not Applicable
Interventional Study Model:	Single Group Assignment
Number of Arms:	1
Masking:	None (Open Label)
Allocation:	N/A
Enrollment:	58 [Anticipated]

Arms and Interventions

Arms	Assigned Interventions
Experimental: Stoma reversal with bio-mesh placement	Procedure: Stoma reversal with bio-mesh placement Patients will receive stoma reversal. During the surgery, a bio-mesh is placed beyond the peritoneum on the surgical site to strengthen the abdominal wall.

Outcome Measures


Primary Outcome Measures:
1.	stoma site incisional hernia [ Time Frame: one-year after surgery ] Hernia occurs on the primary stoma site

Eligibility


Minimum Age:	18 Years
Maximum Age:	75 Years
Sex:	All
Gender Based:
Accepts Healthy Volunteers:	No
Criteria:	Inclusion Criteria: Age: 18-75 years old; Patients should have colonic prophylactic stoma and have not received reversal yet; There are no obvious signs of tumor recurrence or metastasis in tumor patients before stoma resection; No serious underlying diseases, can tolerate general anesthesia surgery Preoperative ECOG (Eastern Cooperative Oncology Group) physical status score 0/1; Preoperative ASA (American Society of Anesthesiologists) grade I-III; Without vital organs function failure; All patients and their families signed informed consent before surgery. Exclusion Criteria: Incapacitated persons; With a history of other types of hernia; Those who have had hernia mesh implantation before; Those who are allergic to bio-mesh or their components before; Combined with other surgeries; Severe mental illness; Severe respiratory disease; Severe liver and kidney insufficiency; Those who have absolute contraindications to surgery; Suffering from severe bleeding disorders or obvious abnormal coagulation function; History of unstable angina or myocardial infarction within 6 months; History of cerebral infarction or cerebral hemorrhage within 6 months; Continuous intravenous application of glucocorticoid within 1 month; The patient has participated or is participating in other clinical studies (within 6 months).

Contacts/Locations


Central Contact Person:	Yonghuan Mao, Dr Telephone: +86 15151877330 Email: maoyonghuan@163.com
Locations:	China, Jiangsu
	Nanjing Drum Tower Hospital [Recruiting] Nanjing, Jiangsu, China, 210000 Contact:Contact: Meilin Jiang, Dr. +86 025-68182923 gyethics@163.com

IPDSharing


Plan to Share IPD:

References


Citations:
Links:
Available IPD/Information: