Adhesions AbdominalNCT05580484
Efficacy and Safety of Purified Starch for Adhesion Prevention in Colorectal Surgery
An observational study of Adhesions Abdominal, run by Taipei Medical University Shuang Ho Hospital at 1 site in Taiwan.
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. Read more about this study
- Who is it for?
- Ages 20 to 100 years
- Conditions the study is for
- Adhesions Abdominal
- What is being tested?
- Second surgery
- Type of treatment
- Surgery or procedure
- How many people
- 83 participants
- Where
- 1 siteTaiwan
- Study dates
- 1 Jan 2020to 30 Jun 2022
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 100 years
- All sexes
- Adult, Older adult
Study population: Patients who underwent a second surgery after colorectal resection.
Who may be able to join
- Patients who underwent a second surgery after colorectal resection between January 2020 and April 2022 were enrolled into this study.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the 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.
- Conditions
- Adhesions Abdominal
- Being tested
- Second surgery
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Second surgeryProcedure or 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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Procedure: Second surgery |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 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).
Measured: three to six months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Oct 2022
- Study start1 Jan 2020
- Primary completion1 May 2022
- Study completion30 Jun 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Adhesions AbdominalStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 83 participants (actual)
Sponsor and investigators
- Lead sponsor
- Taipei Medical University Shuang Ho Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Tungcheng Chang, Taipei Medical University Shuang Ho Hospital
- Investigators
- Tung-Cheng Chang, Study chair, Taipei Medical University Shuang Ho Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05580484
- Sponsor's protocol ID
- N202109018
- Status last verified
- Oct 2022
- First submitted
- 9 Oct 2022
- Last updated
- 14 Oct 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 14 Oct 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy and Safety of Purified Starch for Adhesion Prevention in Colorectal Surgery
- ClinicalTrials.gov ID
- NCT05580484
- Acronym / sponsor ID
- N202109018
- Conditions
- Adhesions Abdominal
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 83 participants (actual)
- Lead sponsor
- Taipei Medical University Shuang Ho HospitalUniversity, hospital or other
- Study start
- 1 Jan 2020 (actual)
- Primary completion
- 1 May 2022 (actual)
- Study completion
- 30 Jun 2022 (actual)
- First posted
- 14 Oct 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Purified starch/Control group | – | Procedure: Second surgeryPatients 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. |
Who may qualify
- Ages
- 20 to 100 years
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- Patients who underwent a second surgery after colorectal resection.
Key inclusion criteria (1 listed)
- Patients who underwent a second surgery after colorectal resection between January 2020 and April 2022 were enrolled into this study.
Key exclusion criteria (1 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Second surgeryThe 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. | Procedure or surgery | Purified starch/Control group |
Primary outcome
Adhesion severity
Time frame: three to six months
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).
Adhesion area
Time frame: three to six months
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).
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Oct 2022.
- Individual participant dataSharing planned: Undecided
Related trials for Adhesions Abdominal
Enrolling by invitationObservational study
Intestinal Obstruction Surgery. Acute Abdominal Pathology. №9:05/05/2026
Small Bowel Adhesion, Obstruction Bowel
Not yet recruitingObservational study
Predictors of Laparoscopy Conversion in Adhesive Small Bowel Obstruction
Adhesive Small Bowel Obstruction
Active, not recruiting
Intra-Abdominal Instillation Of Fresh Frozen Plasma Versus Corticosteroids In Prevention Of Recurrent Attacks Of Adhesive Intestinal Obstruction: A 2 Years' Experience Clinical Study
Adhesive Peritoneal Band
Recruiting
The Effect of Temporary Ovarian Suspension to the Abdominal Wall During Laparoscopic Endometriosis Surgery for Adhesion Prevention -A Comparative and Prospective Study
Endometriosis, Abdominal Adhesions
Not yet recruitingObservational study
Adhesion Prevention in ASBO Surgery Using 4DryField® PH
Adhesive Small Bowel Obstruction, Postoperative Abdominal Adhesions
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Tung-Cheng Chang study chair
Taipei Medical University Shuang Ho Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Adhesions Abdominal, run by Taipei Medical University Shuang Ho Hospital at 1 site in Taiwan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 14 Oct 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Adhesion severity (time frame: three to six months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Oct 2022.