Comparing two laparoscopic techniques for rectosigmoid resection
Conventional Laparoscopic-assisted Rectosigmoid Resection Versus Laparoscopic Rectosigmoid Resection With Intracorporeal Anastomosis and Transrectal Specimen Retrieval
PHASE2 · Universitaire Ziekenhuizen KU Leuven · NCT01033838
This study is testing two different surgical methods for removing part of the colon to see which one helps patients recover better after surgery.
Quick facts
| Phase | PHASE2 |
|---|---|
| Study type | Interventional |
| Enrollment | 1 (estimated) |
| Ages | 18 Years to 90 Years |
| Sex | All |
| Sponsor | Universitaire Ziekenhuizen KU Leuven (other) |
| Locations | 1 site (Leuven) |
| Trial ID | NCT01033838 on ClinicalTrials.gov |
What this trial studies
This clinical trial aims to compare two surgical techniques for rectosigmoid resection: laparoscopic-assisted rectosigmoid resection and laparoscopic rectosigmoid resection with transrectal specimen retrieval. The study involves a hybrid approach where dissection is performed laparoscopically, and the specimen is retrieved through the rectum using an endobag. Patients will be included in a standardized perioperative care program called Enhanced Recovery After Surgery (ERAS) to optimize recovery. The trial will assess the effectiveness and outcomes of these two techniques over a short-term follow-up period.
Who should consider this trial
Good fit: Ideal candidates include adults aged 18-90 with symptomatic recurrent diverticular disease, benign adenomatous polyps requiring surgery, or early non-transmural sigmoid tumors.
Not a fit: Patients who are unsuitable for laparoscopy, pregnant, or have significant comorbidities may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved surgical outcomes and recovery for patients undergoing rectosigmoid resection.
How similar studies have performed: There are currently no available trials in the literature comparing these two specific techniques, making this approach novel.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Age 18-90 * Symptomatic recurrent diverticular disease * Benign adenomatous polyp, requiring surgery * Early non-transmural sigmoidtumor * Signed written informed consent, approved by ethical committee Exclusion Criteria: * Patients unsuitable for laparoscopy * Pregnancy * ASA \>III * Coagulation disorders * Anti-coagulants
Where this trial is running
Leuven
- University Hospitals Leuven — Leuven, Belgium (RECRUITING)
Study contacts
- Study coordinator: Albert M Wolthuis, MD
- Email: albert.wolthuis@uzleuven.be
- Phone: +3216344265
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Symptomatic Recurrent Diverticular Disease, Benign Adenomatous Sigmoidal Polyp, Requiring Surgery, Early Non-transmural Sigmoidtumor