Efficacy and Safety of Purified Starch for Adhesion Prevention in Colorectal Surgery

Intra-abdominal adhesion occurs in up to 90% of patients after abdominal surgery. Many patient will undergo a second surgery for temporary stoma closure, therefore these ostomy closure operations can give an opportunity to evaluate adhesion caused by previous operations. This study was conducted to use second surgery to investigate the anti-adhesion effect of purified starch among patients who underwent colorectal surgery.

Study Overview

• Status: Completed
• Conditions: Adhesions Abdominal
• Intervention / Treatment: Procedure: Second surgery

Detailed Description

Data was analyzed from the medical records of patients who underwent a second surgery after colectomy between January 2020 and April 2022. Patient were allocated to either the purified starch group and control group. Since January 2020, adhesion scores have been registered in operation note when patients undergo a second colorectal surgery. The primary outcomes in this study were adhesion severity and adhesion area. The secondary outcomes were operation time, blood loss, and postopera-tive complications.

• Study Type: Observational
• Enrollment (Actual): 83

Contacts and Locations

Study Locations

• Taiwan
  • New Taipei City, Taiwan, 235
    • Taipei Medical University Shuang-Ho Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years to 100 years (Adult, Older Adult)
• Accepts Healthy Volunteers: N/A
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Patients who underwent a second surgery after colorectal resection.

Description

Inclusion Criteria:

• Patients who underwent a second surgery after colorectal resection between January 2020 and April 2022 were enrolled into this study.

Exclusion Criteria:

• Patients who underwent a second surgery less than 1 month after the first colorectal resection or who developed peritoneum carcinomatosis in the second surgery and patients younger than 20 years were excluded.

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Retrospective

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Purified starch/Control group; Patients who were willing to receive purified starch at their own expense during this first surgery were included in the purified starch group, and patients who did not re-ceive purified starch or other anti-adhesion products were included in the control group.	Procedure: Second surgery; The primary outcomes were adhesion severity and adhesion area in the lower ab-dominal cavity, as determined through direct visual observation of a laparotomy wound or laparoscopic observation from stoma closure wound.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Adhesion severity	Adhesion severity was scored as grade 0 (no adhesion), grade I (filmy adhesion and blunt dissection), grade II (strong adhesion and sharp dissection), and grade III (very strong vascularized adhesion, sharp dissection, and damage barely preventable).	three to six months
Adhesion area	Adhesion area was scored as grade 0 (no adhesion), grade I (adhesion of less than one-third of the area between the abdominal wall and the visceral organ in the lower abdominal cavity), grade II (adhesion of one-third and two-thirds of the area between the abdominal wall and the visceral organ in the lower abdominal cavity), and grade III (adhesion of more than two-thirds of the area between the abdominal wall and the visceral organ in the lower abdominal cavity).	three to six months

Collaborators and Investigators

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

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2020
• Primary Completion (Actual): May 1, 2022
• Study Completion (Actual): June 30, 2022

Study Registration Dates

• First Submitted: October 9, 2022
• First Submitted That Met QC Criteria: October 12, 2022
• First Posted (Actual): October 14, 2022

Study Record Updates

• Last Update Posted (Actual): October 14, 2022
• Last Update Submitted That Met QC Criteria: October 12, 2022
• Last Verified: October 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Fibrosis; Cicatrix; Tissue Adhesions
• Other Study ID Numbers: N202109018

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