A Phase 2 interventional study of rectosigmoid resection in Symptomatic Recurrent Diverticular Disease, Benign Adenomatous Sigmoidal Polyp, Requiring Surgery and Early Non-transmural Sigmoidtumor, sponsored by Universitaire Ziekenhuizen KU Leuven. Recruiting at 1 site in Belgium. Open to participants aged 18 Years to 90 Years. Per ClinicalTrials.gov, last updated 2024-07-01.
Sponsored by Universitaire Ziekenhuizen KU Leuven · Phase 2, Interventional, and Treatment
Laparoscopic anterior resection is a standardized procedure requiring a small muscle split incision to retrieve the specimen and to fashion the proximal part of the double stapled anastomosis. Most patients can be included within a standardized perioperative care program called Enhanced Recovery After Surgery (ERAS). A new evolution as a primary step towards a complete Natural Orifice Translumenal Endoscopic Surgery (NOTES)-procedure is a hybrid approach (transrectal and laparoscopic). The dissection is performed laparoscopically but the specimen is retrieved within an endobag through the rectum. The anastomosis is created intracorporeally using a triple stapled technique. There are no trials available in the literature concerning these 2 techniques. Therefore this study will be undertaken to establish the role of the 2 surgical procedures and to compare them after short-term follow-up.
44 studies on the registry are indexed under Diverticular Diseases; 9 are open to participants now.
This study's planned enrollment of 1 is below the median of 81 across 31 interventional studies indexed under Diverticular Diseases.
Browse Diverticular Diseases studies →Universitaire Ziekenhuizen KU Leuven is the lead sponsor of 963 studies on the registry; 267 are open to participants now.
Of its 5 completed or terminated interventional studies of FDA-regulated products, 0 (0%) have results posted.
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Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Procedure: rectosigmoid resection
Procedure: rectosigmoid resection
Reduction in analgetic need
reduction in hospital stay within an ERAS-program
effect on the inflammatory response
effect on anal continence
procedural cost assessment (incorporating operative time)
overall cost assessment
The record gives a start of Dec 2009, a primary completion of Dec 2011 and a completion of Jun 2025. It does not say whether these dates are actual or estimated.
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