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

Adhesions Abdominal Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05580484
• Other study ID #: N202109018
• Status: Completed
• Start date: January 1, 2020
• Est. completion date: June 30, 2022

Study information

• Verified date: October 2022
• Source: Taipei Medical University Shuang Ho Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 83
• Est. completion date: June 30, 2022
• Est. primary completion date: May 1, 2022
• Gender: All
• Age group: 20 Years to 100 Years

Eligibility

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.

Related Conditions & MeSH terms

• Adhesions Abdominal
• Tissue Adhesions

Intervention

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.

Locations

Country	Name	City	State
Taiwan	Taipei Medical University Shuang-Ho Hospital	New Taipei City

Sponsors (1)

Lead Sponsor	Collaborator
Taipei Medical University Shuang Ho Hospital

Country where clinical trial is conducted

Taiwan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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