The Efficacy and Safety of Using Collagen Patch on Anastomotic Site in Colorectal Surgery

Taipei Medical University Shuang-Ho Hospital

In order to investigate the effects of collagen wound dressing on colonic anastomosis during colectomy, we conducted a retrospective cohort study. The goal of study was to determine whether the use of collagen wound dressing results in improving clinical outcomes for patients undergoing laparoscopic colectomy.

Study Overview

• Status: Completed
• Conditions: Anastomosis, Functional
• Intervention / Treatment: Procedure: Laparoscopic colectomy

Detailed Description

Wound healing occurs in four distinct phases: hemostasis, inflammation, proliferation, and tissue remodeling. Numerous factors can influence these phases, which can be classified as either local or systemic. Local factors include infection, presence of foreign bodies, inadequate oxygenation, and other issues affecting the wound itself, while systemic factors encompass a wide range of considerations such as age, gender, presence of systemic disease, ischemia, stress, medication use, obesity, cigarette and alcohol use, nutritional status, and immunocompromised conditions.

Anastomotic healing in the colon is similar to the healing process in skin while there's still some differences. While the cellular and histological processes involved in colonic healing are well known, the pathophysiological process is not fully understood and requires further studies . Unlike skin healing, the process of patients undergoing colonic resection and anastomosis healing can only be inferred by observing certain parameters, such as amount of drainage, time to first flatus and defecation and the patient's symptoms. These parameters are used to guide the patient's recovery program. Complications such as anastomotic leakage, bleeding or stricture would lead to longer hospital stay, mortality and morbidity. The most devastating one is anastomotic leakage. Although we have found some strategies to lower the rate in colorectal surgery such as colon preparation or antibiotics administration, the leakage still bothers a lot.

Besides controlling the local and systemic factors, several biomaterial products have been designed to progress the healing. Collagen plays crucial roles in all of the four healing phases. As a result, collagen wound dressing, derived from bovine, equine, avian or porcine, has been applied in different sites of wound to promote healing. Several studies have concluded that collagen wound dressing resulted in better outcomes but limited to in vitro studies or animal based research. Pantelis D. concluded that fibrin in combination with the collagen patch can improve healing in high-risk mice that underwent colonic anastomosis surgery. Pommergaard HC. also concluded that the collagen wound dressing can lower the leakage rate in mouse colon anastomosis surgery.

Another limitation is that most studies have small sample sizes and lack of long term observation. Parker et al designed a non-randomized study and concluded that collagen wound dressing is safe and easy to apply in human colorectal surgery. Marano et al compared the complication rate of two cohorts and revealed that collagen wound dressing can lower the complication rate in the patients who underwent upper gastrointestinal surgery. As of now, it is premature to conclude that collagen wound dressing is effective in human colonic anastomosis due to the lack of human studies and larger sample size. In order to investigate the effects of collagen wound dressing on colonic anastomosis during colectomy, we conducted a retrospective cohort study. Our goal was to determine whether the use of collagen wound dressing results in improving clinical outcomes for patients undergoing laparoscopic colectomy.

• Study Type: Observational
• Enrollment (Actual): 241

Contacts and Locations

Study Locations

• Taiwan
  • New Taipei City, Taiwan, 235
    • Taipei Medical University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Patients who underwent laparoscopic colectomy.

Description

Inclusion Criteria:

• Patients who underwent laparoscopic colectomy.

Exclusion Criteria:

• Patients who underwent open surgery, emergent surgery, or had prior chemotherapy or concurrent chemoradiotherapy were excluded from the study

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Collagen group /Control group; Patients who received collagen patches on the anastomotic site during colectomy were allocated to the collagen group. Patients without collagen patches on the anastomotic site during colectomy were allocated to the control group.	Procedure: Laparoscopic colectomy; Patients who under went laparoscopic colectomy

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Bowel function recovery	The primary outcome measurements were the number of days until first flatus and defecation after surgery, which were recorded as the number of days from surgery to the first occurrence of each event.	0-30 days after colectomy

Collaborators and Investigators

• Sponsor: Taipei Medical University Shuang Ho Hospital
• Investigators: Study Chair: Tung-Cheng Chang, MD,PhD, Taipei Medical University Shuang Ho Hospital

Study record dates

Study Major Dates

• Study Start (Actual): September 28, 2022
• Primary Completion (Actual): February 24, 2023
• Study Completion (Actual): March 15, 2023

Study Registration Dates

• First Submitted: April 16, 2023
• First Submitted That Met QC Criteria: April 16, 2023
• First Posted (Actual): April 26, 2023

Study Record Updates

• Last Update Posted (Actual): April 26, 2023
• Last Update Submitted That Met QC Criteria: April 16, 2023
• Last Verified: April 1, 2023

More Information

Terms related to this study

• Other Study ID Numbers: N202209004

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No