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Compares treatment options for Ileostomy
Official title A Study Comparing Laparoscopic/Robotic Stoma Reduced-Port Fusion Surgery with Traditional Surgery in Patients with Temporary Ileostomy
ClinicalTrials.gov ID: NCT06604052
What this study is testing
- What it's testing
- The traditional positioning and surgical methods for temporary ileostomy no longer meet the requirements of minimally invasive surgery: (1) Conventional stoma positioning often leads to the trocar incision being too close to the stoma site, increasing the risk of baseplate leakage and skin infection. (2) Since stoma positioning is required to be within the rectus abdominis, the proximity between the stoma and auxiliary incision can heighten difficulties in stoma bag attachment and raises the risk of fecal leakage.
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- After preoperative evaluation, patients scheduled for laparoscopic/robotic colorectal surgery (rectum, sigmoid colon, left colon) who are planned to...
- No serious systemic infection or immunosuppression.
- Over 18 years of age.
- Eastern Cooperative Oncology Group Performance Status: 0-1
- The expected survival time \> 6 months.
You likely can't join if
- Any skin infectious diseases in the abdominal wall.
- Use hormones and immunosuppressive drugs within 1 month before surgery.
- The time between operation and the last chemotherapy was less than 1 month.
- Any previous ostomy surgery.
- Any serious active infection or uncontrollable infection that requires systematic treatment.
- A clear history of neurological or psychiatric disorders.
See the full eligibility criteria
- After preoperative evaluation, patients scheduled for laparoscopic/robotic colorectal surgery (rectum, sigmoid colon, left colon) who are planned to undergo prophylactic ileostomy.
- No serious systemic infection or immunosuppression.
- Over 18 years of age.
- Eastern Cooperative Oncology Group Performance Status: 0-1
- The expected survival time \> 6 months.
- The people voluntarily participate and sign the informed consent
- Any skin infectious diseases in the abdominal wall.
- Use hormones and immunosuppressive drugs within 1 month before surgery.
- The time between operation and the last chemotherapy was less than 1 month.
- Any previous ostomy surgery.
- Any serious active infection or uncontrollable infection that requires systematic treatment.
- A clear history of neurological or psychiatric disorders.
- people may not be able to complete the study for other reasons.
The study team makes the final eligibility decision.
Where it's taking place
- Shanghai, China, China
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Shanghai, China, China. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.