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

NCT05580484 | Completed

• 1 other identifier: N202109018
• Study Type: observational
• Target: 83
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Adhesions Abdominal

Outcome Measures

Primary Outcomes (2)

• 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

Study Arms (1)

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

Interventions

Second surgery PROCEDURE

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.

Purified starch/Control group

Eligibility Criteria

• Age: 20 Years - 100 Years
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients who underwent a second surgery after colorectal resection.

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Taipei Medical University Shuang Ho Hospital: lead

Study Sites (1)

Taipei Medical University Shuang-Ho Hospital

New Taipei City, 235, Taiwan

Location

MeSH Terms

Interventions

Second-Look Surgery

Intervention Hierarchy (Ancestors)

Surgical Procedures, Operative

Study Officials

• Tung-Cheng Chang

  Taipei Medical University Shuang Ho Hospital

  STUDY CHAIR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Chief of department of colorectal surgery

Study Record Dates

• First Submitted: October 9, 2022
• First Posted: October 14, 2022
• Study Start: January 1, 2020
• Primary Completion: May 1, 2022
• Study Completion: June 30, 2022
• Last Updated: October 14, 2022

Record last verified: 2022-10

Locations

TW (1)