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

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

Status
Recruiting
Phases
Phase 2
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01033838
Acronym
LATA
Enrollment
1
Registered
2009-12-17
Start date
2009-12-31
Completion date
2025-06-01
Last updated
2024-07-01

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

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

Brief summary

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.

Interventions

Sponsors

Universitaire Ziekenhuizen KU Leuven
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)

Eligibility

Sex/Gender
ALL
Age
18 Years to 90 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frame
Reduction in analgetic need

Secondary

MeasureTime 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

Countries

Belgium

Contacts

Primary ContactAlbert M Wolthuis, MD
albert.wolthuis@uzleuven.be+3216344265

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 5, 2026