Randomized Trial Comparing Laparoscopic-assisted Rectosigmoid Resection Versus Laparoscopic Rectosigmoid Resection With Transrectal Specimen Retrieval

Study Overview
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Brief Summary
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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.

Official Title
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Conventional Laparoscopic-assisted Rectosigmoid Resection Versus Laparoscopic Rectosigmoid Resection With Intracorporeal Anastomosis and Transrectal Specimen Retrieval

Conditions
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Symptomatic Recurrent Diverticular Disease, Benign Adenomatous Sigmoidal Polyp, Requiring Surgery, Early Non-transmural Sigmoidtumor

Intervention / Treatment
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* Procedure: rectosigmoid resection


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 90 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: laparoscopic-assisted rectosigmoid resection<br> | Procedure: rectosigmoid resection<br> <br> |
| Experimental: laparoscopic rectosigmoid resection and transrectal retrieval<br> | Procedure: rectosigmoid resection<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Reduction in analgetic need |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 |  |  |